Pharma-Net

Investing in Pharmaceutical Companies

2012-05-01T22:22:00.001-03:00

The pharmaceutical companies seem to be immune to the economic ups and downs that countries across the world go through. Illness and disease are an ongoing thing in life and it is due to this reason that the pharmaceutical companies have always been in business and were least affected by the economic ups and downs that have been experienced by different countries in the recent past. The global economies have been affected by recession, and most of the industries have been affected by the impact of recession. Banks have declared bankruptcy, automobile industry has got affected and even the service sector has laid-off so many people and this has all been a result of the recent recession.

However, the pharmaceutical industry has been able to sustain itself very well during all this time and continues to do so. Although e have seen mergers and acquisitions happening even in the pharmaceutical industry, yet the effect of recession on this industry has been much less when compared with the other industries.

For people thinking about investing in the pharmaceutical companies, there are a few pointers they might wish to know:

Â· Investing in this companies is not fool proof however if you compare it with any other industry, it would surely be rated as one of the most secure investments.

Â· Recession has not spared any segment or industry in the market today, each and every industry has felt the impact of the economic slowdown however all the different industries have felt the impact in varying degrees. The pharmaceutical industry has been affected the least but it too has not been able to totally escape the impact of recession.

Â· Illness and diseases are surely not affected by recession and that is one reason why the pharmaceutical companies have been able to comfortably sustain themselves during the economic slowdown. We have seen pharmaceutical companies merging and have also seen many people being laid off in this industry. Despite of these facts the pharmaceutical industry has shown less fluctuations in comparison to the banking and automobile industries.

Â· Investing in the pharmaceutical companies is still considered to be a very safe option in comparison to the automobile or banking sector. The reason for this is that the automobile industry has seen the shut down and merging of certain companies and the banking sector has seen the acquisition of many banks and also the filing of bankruptcy by some eminent banks in the past few years. While the pharmaceutical companies have also shown signs of being affected by the economic slowdown the magnitude of impact on pharmaceutical companies has been very low.

Keeping these few pointers in mind the general feeling in the investment market is that the pharmaceutical companies are a decent investment with safe return, especially in today's economically slow pace. Therefore most people are now skeptical about investing in other industries and choose to invest in the pharmaceutical companies so that they can experience the safety of their investment and not be bothered about a sudden shut down.

To find out more about investing in pharma companies you can go to http://www.medisan.com/. They also provide with many information and tips investing.

Article Source: EzineArticles.com

Are pharmaceutical companies using African babies as guinea pigs?-Africa Today-02-21-2012

2012-05-01T22:22:00.000-03:00

Major Pharmaceutical Companies

2012-05-01T22:21:00.006-03:00

Pharmaceutical companies have a major social responsibility while performing on a profitable motive. Several public platforms are shared by major pharmaceutical companies for this very purpose.

The pharmaceutical industry has several issues to contend with for profitable survival. The United States does not have regulations for drug prices, but several other regulations monitor the functioning of pharmaceutical companies in the country. Fierce competition from illegal drug imports is also an issue that cannot be ignored by major pharmaceutical companies.

There are several associations that represent pharmaceutical manufacturers. The International Federation of Pharmaceutical Manufacturers and Associations is an organization that is at the apex. It is a non-profit and non-governmental organization. Its members are several research based pharmaceutical, biotech and vaccine companies from both USA and other countries as well.

Organizations such as these, work for a global policy environment that is conducive to innovation in the pharmaceutical field. A survey of major pharmaceutical manufacturers indicates that collectively the industry has almost 700 medicines in the pipeline. These medicines are aimed at providing relief to people suffering from various diseases like HIV/AIDS, cancer, heart diseases and stroke among others.

The existence of a platform like an international association provides opportunities to major pharmaceutical companies to have collaborative relationships among themselves and foster industry growth in such a manner that provides avenues for overall improvement in public health while being commercially profitable.

One of the major pharmaceutical companies is Eli Lily, a global player. Their specialties include drugs for cancer, cardiovascular diseases, neurological disorders, endocrinal disorders, diabetes and several infectious diseases. Cephalosporin, erythromycin, insulin and Prozac are among Eli Lily's major pharmaceutical breakthroughs. Pfizer is another major pharmaceutical company that has contributed a lot to alleviate human and animal suffering. Based in New York, Pfizer has been around since 1849.

Parke-Davis, Proctor & Gamble, Bristol-Myers Squib, Johnson & Johnson, 3M Company, Mars Incorporated, Bayer AG, Quest Diagnostics, Tyco International and Cardinal Health Incorporated are a few of the major pharmaceutical companies in the USA.

Pharmaceuticals [http://www.Pharmaceuticals-Web.com] provides detailed information on Pharmaceuticals, Pharmaceutical Companies, Pharmaceutical Jobs, Pharmaceutical Naming and more. Pharmaceuticals is affiliated with Mexican Online Pharmacy.

Article Source: EzineArticles.com

Bill Maher - Anti-Pharma Rant

2012-05-01T22:21:00.005-03:00

The Rise of the Indian Pharmaceutical Companies

2012-05-01T22:21:00.004-03:00

The Indian Pharmaceutical industry is the 4th largest industries in the world. It consists of around 20,000 businesses. Pharmaceutical companies in India are on a roll both on domestic as well as international grounds. Pharmaceutical companies boast of skillful workforce along with the latest technology in use. These features help to expand their market and business overseas.

The latest trend in the pharmaceutical business is the tie-ups between Multi National Companies and Indian Pharmaceutical companies. These MNCs turn to their Indian counterparts to achieve cost-efficiency in terms of R & D. Besides offering skill and technology, offer affordable Research and Development facilities. For example, mergers and acquisitions between MNCs and Indian pharmaceutical companies are common for research on third world diseases like cancer, AIDS, etc.

Moreover, India is gradually moving up from being just a service provider to a value-add in profits. Here, MNCs purchase / license new products or share Intellectual Property. Pharmaceutical companies of India are slowly becoming a popular destination for collaborative research and development.

Adding to this is the success of the Indian pharmaceutical industry as an exporter of high quality generic drugs. The companies owe this success to the system of product patents which were introduced on 1stJanuary, 2005. Now, the Indian pharmaceutical industry exports drugs to approximately 65 countries around the world with the United States as its biggest market. The industry's export was worth US 3.75 billion dollars and growing at a compound annual rate of 22.7% according to the National Pharmaceuticals Policy for 2006.

However, the these companies can hope to achieve more by discovering untapped markets both in India as well as abroad. Another area that calls for attention is the Research & Development department. The government needs to invest more for Research & Development as innovative drugs are high on demand.

Also, the relationship between pharmaceuticals and biotechnology in India needs to be more cemented. This is because biotechnology has a lot of room for growth with the rise in vaccines and bio - services. Lacks of funding and skilled employees are the obstacles for the development of biotechnology in Indian pharmaceutical companies. However, a wind of change is expected as the drugs go off patent, giving the Indian pharmaceutical companies an opportunity to upgrade their manufacturing capabilities.

To conclude, the companies have a lot of potential in store. It is estimated that the Indian pharmaceutical industry will soon enter the top 10 list of the pharmaceutical industries in the world.

Pharmaceutical companies of India are growing its pharmaceutical business to keep the feet stuck in world pharma industry.

Article Source: EzineArticles.com

Swine flu win-win game for pharmaceutical companies

2012-05-01T22:21:00.003-03:00

Pharmaceutical Companies

2012-05-01T22:21:00.002-03:00

Pharmaceutical companies are companies licensed to discover, manufacture and distribute pharmaceutical medicines or drugs. Currently there are about 200 major pharmaceutical companies in the world and some of them use biotechnology to produce drugs. This particular technique uses biological systems or living organisms to obtain derivatives. Drugs thus obtained are typically known as biopharmaceuticals, which are turning out to be another important aspect for the companies. In recent times technology has developed more efficient methods and informatics systems through which the companies study diseases that cause infections and other symptoms. This study is further used to invent new medicines by identifying active ingredients of traditional medicine.

Pharmaceutical companies have full-fledged laboratories that are equipped with latest infrastructure, wherein chemists and scientists work continuously to identify factors such as genetics and cellular structure that play an important role in various diseases. Establishing this facility is an expensive affair. The companies are required to have post approval, sales surveillance and a license from the government prior to clinical test of the drugs. Clinical testing involves three stages, of which the first stage determines the safety and tolerability of the drug. The second and third stages determine the effectiveness of these drugs. Extensive drug tests are done on animals before they are administered to humans.

Physicians play a major role in the sales of medicines of pharmaceutical companies. It is through their prescriptions, that medicines reach patients and have a potential for widening the market. Hence, these companies advertise and market their products to the physicians first. Pharmaceutical marketing is complex and requires indigenous discipline.

Some of the major pharmaceutical companies that are known all over the world are Pfizer, Glaxosmithkline and Sanofi-Aventis. These companies patent all their products, as the risk of forgery is substantially large in this field. Development in the field of medicine has enabled doctors to provide solutions for diseases, which were incurable earlier. Pharmaceutical companies play the role of lifesavers.

Article Source: EzineArticles.com

The real Drug Pushers (Pharmaceutical Companies)

2012-05-01T22:21:00.001-03:00

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA
> Vaccine Development and Approval: Phase 2 and Beyond - November 7-8, 2011 - Philadelphia, PA

How Web Document Management Software Empowers Pharmaceutical Companies

2012-05-01T22:21:00.000-03:00

In the pharmaceutical industry the clock is ticking at the rate of warp-speed "drug years." Pharmaceutical industries have 8 (possibly up to 12 years) to discover, conceptualize, define, develop and commercialize--as opposed to market--pre-market drug information. This process of course results in a financial tab of about $200-$900 million dollars--numbers that are subject to vary depending on your sources and on the amount of time taken for the various phases of drug development. At any rate however the monetary costs of a new start-to-finish drug (and more so for failed drugs) are likely to be impressively enormous. No matter how you look at it the pharmaceutical wallet becomes reciprocally thinner as the "drug-years" clock continues to tick.

Drug Patents: How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Another motivating factor for pharmaceutical industries to rush the clock are patent laws. Drug patents, of course, create a window--a very large window if strategized correctly--to a monopolized gain on the sale of a new drug. Current laws place patent years at around 17 so if a company spends 11 years in the development phases it has exactly six uninterrupted years to achieve market gain to the fullest--no easy task for even the BIG guys.

Both financial costs and patent pressures cause pharmaceutical companies to rush, to lose their opportunity for sales completely, or worst case scenario, to cause eventual problems, even death, for patients. How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Enter Web Document Management

Web document management, when utilized in small, medium, or large pharmaceutical companies and in conjunction with their satellites and CROs can literally shave drug years off the pharmaceutical clock. Web document management solutions combined with web process, quality, regulatory, training and submissions preparation solutions can subtract even more drug years leaving more free-for-all patent time. Best of all however these solutions systematize and automate solutions, trend information and make it easier to get quality, regulation, training, documentation and all company processes under control so that patients stay safe and pharmaceutical companies gain.

As in so many instances technology steps in and effortlessly ties two endeavors together with increased effectiveness on both ends of the spectrum.

One Solution at a Time: Start with Web Document Management

For pharmaceutical companies that cannot invest in all of these solutions at once, start with a web document management solution. A web document management solution will and should be able to manage tens of thousands and even hundreds of thousands of documents from lab notebook entries, study data, biomarkers, formulation studies, statistical analyses, GLP compliance docs, patent analyses, lead generation reports, market analysis, financial statements, manufacturing scenarios, patent filings, product commercial path scenarios, IND submission strategies, toxicology reports, templates, etc., etc.

The web document management solution should also provide web-based collaboration features, the technology to quickly scan paper documents into the system, a user-friendly interface, tracking/audit trail features, 21 CFR Part 11 compatibility, revision controls, reporting features and compatibility with training software controls. The system should also be compatible with common ERP solutions.

Conclusion

When used correctly technology (such as the increasingly popular web document management software solutions) is always an enabler and essentially allows pharmaceutical companies the ability to get the data they need faster so that the right decisions can be made for both patients and the interests of the company and its employees. Pharmaceutical regulatory, quality, IT and management representatives should select four or five web document management software vendors and compare them seriously. The web document management software vendor chosen could be the means of a pharmaceutical company's success after its next successful IND.

Marci Crane is a copywriter at MasterControl in Salt Lake City, Utah. For more information about web document management in pharmaceutical environments, please feel free to contact a MasterControl representative.

Article Source: EzineArticles.com

Fwd: | 09.01.11 | IOM: Vaccines cause very few side effects

2011-09-01T21:34:00.000-03:00

If you are unable to see the message below, click here to view.

September 1, 2011

Subscribe | Website | Jobs
Refer FierceVaccines to a Colleague

Spotlight:
Emory University receives $26M from NIH

Also Noted:
Ebola and rabies protection in one vax?; BiondVax starts Ph2 universal flu vax trial; Much more...

News From The Fierce Network:
1. Researchers find influenza B spread clues
2. Unilife aims prefilled syringes at patients
3. Facebook app shows how people swap germs

Events

Marketplace

> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Today's Top Stories

1. IOM: Vaccines cause very few side effects

By Maureen Martino

The IOM has conducted an exhaustive survey of almost 1,000 research studies and concluded that vaccines are tied to very few and usually mild side effects. The expert panel examined 8 common vaccines: MMR, DTaP, varicella for chickenpox, influenza, hepatitis B, meningococcal, tetanus-containing vaccines and the HPV vaccine, according to Reuters.
The IOM determined the vaccines weren't tied to an increased risk of autism or Type 1 diabetes. Side effects did include high fevers, allergic reaction and seizures, but in most cases they subsided quickly. "Despite looking very hard, it was really hard to find that vaccines cause injuries and the injuries they do cause are generally pretty mild and self-contained," said committee chair Ellen Wright Clayton, director of the Center for Biomedical Ethics and Society at Vanderbilt University in Nashville, in an interview with Reuters.
An increasing number of parents are skipping their kids' vaccinations due to misguided fears about serious side effects. Lower vaccination levels have led to outbreaks of whooping cough and measles in recent years. The IOM may ease the concerns of some parents, but it's unlikely to sway the staunchest anti-vaccine crusaders.
"The big take-home message is that we found only a few cases in which vaccines can cause adverse side effects, and the vast majority of those are short-term and self-limiting," added Clayton.
- here's the full IOM report
- take a look at the Reuters story
Related Articles:
Report: Higher income parents increasingly forgoing kids' vaccinations
Study: No benefit to spreading out vaccines

Read more about: vaccine safety
back to top

2. CDC: Teen HPV vaccination rates lagging

By Maureen Martino

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=75&ms=MzYyNTk4MwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTE0MTgwMjE1S0&mt=1&rt=0" name="api_addthis_com_oexchange_CVyTPw050bW0jgEfMIZBFw" >Twitter | Facebook | LinkedIn

The CDC says HPV vaccination rates continue to lag those of other vaccines recommended for teenagers. Just 49% of teens got one dose of the HPV shot, and only 32% of girls got all three recommended injections. That's up just 5% from the previous year. Comparatively, 63% of kids got the meningitis shot, and 69% received the Tdap vaccine. Blacks and Hispanics were less likely to receive the third HPV dose compared with whites. Additionally, girls living in poverty were also less likely to complete the HPV series, according to the CDC release.
Each year, 6 million men and women are infected with HPV, which can eventually cause cervical cancer and other diseases. Gardasil and Cervarix prevent the most common strains of the virus, but all three doses must be given to achieve maximum protection.
"...[T]he HPV results are very concerning," noted Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. "Our progress is stagnating, and if we don't make major changes, far too many girls in this generation will remain vulnerable to cervical cancer later in life. Now that we have the tools to prevent most cervical cancers, it is critical that we use them." The study was published in the CDC's Morbidity and Mortality Weekly Report.
- see the CDC release
- here's more from HealthDay
Related Articles:
Patient education needed for HPV vaccines, cancer screenings
Study: Support of mandatory HPV vaccine declines after negative news coverage
HPV shot provides sustained protection against pre-cancerous growths

Read more about: Cervarix, HPV, Gardasil
back to top

3. Infant rotavirus shots benefit the unvaccinated

By Erica Teichert

Refer FierceVaccines to a Colleague

Researchers have found that vaccinating infants against rotavirus may help protect the unvaccinated children and adults around them.
In a CDC study published in The Journal of Infectious Diseases, there were fewer rotavirus-related hospital admissions after the vaccine was introduced in 2008 than from 2000 to 2008. Ben Lopman, one of the scientists involved in the study, believes this is due to infant vaccinations.
"Our study showed that the burden of rotavirus--severe enough to require hospitalization--in older children and adults is larger than we were previously aware," Lopman said, according to Medical News Today. "And by vaccinating infants, we can indirectly prevent this burden of disease, thereby amplifying public health and economic benefits of infant vaccination."
In addition, fewer hospitalized rotavirus patients led to lower overall costs. "We estimate that 15% of the total 66,000 averted hospitalizations and 20% of the $204 million in averted direct medical costs attributable to the vaccination program were among unvaccinated 5-24 year-olds," according to the study, as quoted by CBC.
- read the CBC News article
- here's more from Medical News Today
Related Articles:
Rotavirus vax campaign would save millions of lives
Merck's rotavirus vaccine makes big impact

4. New strain of H5N1 lacks vax protection

By Erica Teichert

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=138&ms=MzYyNTk4MwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTE0MTgwMjE1S0&mt=1&rt=0" name="api_addthis_com_oexchange_JMSNUaD4pWtowK2ciPo4w" >Twitter | Facebook | LinkedIn

Scientists have discovered a mutant strain of the bird flu, which has been observed in China and Vietnam, and the variant is different enough that current vaccines won't protect against it.
So far, the strain is contained within poultry and birds, but H5N1-2.3.2.1--the name given to the new strain--could transfer to people. "There is a human H5N1 vaccine candidate that is a (WHO) recommended vaccine...But it doesn't confer full protection against the (new variant)," said virologist Malik Peiris of the University of Hong Kong, as quoted by Reuters. The news outlet noted 8 people have been infected with H5N1 in Cambodia this year, and all have died.
H5N1 previously made headlines when the virus spread to 63 countries from 2003 to its peak in 2006. Reported cases of the flu strain have risen consistently since 2008.
- check out the Reuters coverage
- and here's the Chron post
Related Articles:
Scientists easily create hybrid virus
Computing method offers shortcut to right flu vax
Smallpox vax highly effective against bird flu

Read more about: flu vaccine, bird flu, H5N1
back to top

Also Noted

TODAY'S SPOTLIGHT... Emory University receives $26M from NIH

The NIH has awarded Emory University a $26 million grant for its work on HIV/AIDS vaccines. The university will work to develop a vaccine in the next 5 years with the help of such partners as the Yerkes National Primate Research Center, Mt. Sinai School of Medicine, La Jolla Institute of Allergy and Immunology, University of Nebraska and Louisiana State University Health Sciences Center. Item
Vaccine Research
Researchers have discovered a potential vaccine that would protect against rabies and Ebola in a single jab. According to Thomas Jefferson University scientists, the candidate has showed promising results in mouse trials and could make a significant impact in developing nations where both diseases put people at risk. Item | Piece
Israeli biotech BiondVax is beginning its Phase II universal flu vaccine trial for Multimeric-001. The trial will include 120 patients who are 65 years of age and older and will start in October. BiondVax release
HCM City Pasteur Institute is in the home stretch for its dengue fever vaccine in connection with Sanofi Pasteur. The vaccine will start its final clinical trial in Vietnam next month. Item
Vaccine has published the results of Emergent BioSolutions' ($EBS) Phase Ia anthrax vaccine trial, noting the good responses from BioThrax with 1 mg of CPG 7909 in the 69-person trial. Emergent release
Scientists have found a link between a bovine viral diarrhea virus and bleeding calf syndrome, which causes low blood cell counts and bone marrow depletion in newborn calves. The study was published in Veterinary Research. Release
Vaccine Market
Selecta Biosciences has garnered a malaria vaccine subcontract from Science Applications International with support from NIAID. In addition, the company has named Takashi Kei Kishimoto as its new chief scientific officer. Article
And Finally... Russia's chief sanitary inspector Gennady Onishchenko believes his country is being cast aside by UNICEF's polio vaccination efforts, and that possibility is dangerous for the nation's biotech industry. Item

Events

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here

> Vaccine Development and Approval: Phase 2 and Beyond - November 7-8, 2011 - Philadelphia, PA

The unique demands of vaccine trials require discussion among all stakeholders with clarification of expectations and sharing of lessons learned. This conference will provide an opportunity to present key issues and case studies from industry and regulatory professionals on such topics as adaptive designs for vaccine trials, regulatory expectations, new pathways to approval and data challenges. Address Issues and Challenges of Vaccine Development from Phase 2 to Licensure. Register Today!

Marketplace

> Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

Jobs

> Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics

Regulus Therapeutics Inc. is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus seeks a motivated 6 plus years of drug development experience to join our efforts in translating microRNA biology into human therapeutics. The position requires proven ability to work in a fast-paced biotech environment. Read more.

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

©2011 FierceMarkets This email was sent to nbrauchitsch@yahoo.com as part of the FierceVaccines email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778.

Editor-in-Chief: John Carroll. Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

Manage your subscription
Change your email address
Unsubscribe from FierceVaccines

Explore Our Network

You may enjoy these publications from FierceMarkets:

Custom Search

Fwd: | 08.09.11 | Will Valeant snap up Medicis?; Yervoy could soon face Roche rival

2011-08-10T00:15:00.001-03:00

-------- Original Message --------

Subject:	\| 08.09.11 \| Will Valeant snap up Medicis?; Yervoy could soon face Roche rival
Date:	Tue, 9 Aug 2011 13:19:54 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

August 9, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsors:
IBM Webinar
Fierce Custom Publishing
Kru Research

Spotlight:
Study: Revlimid interaction may explain side effects

Also Noted:
KV Pharma completes generics-unit sale; Gedeon Richter wins dispute over buyout; Much more...

News From The Fierce Network:
1. QIAGEN submits PMA for companion Dx
2. Roche deals API plants in SC, CO
3. Gene regulates the timing of our tickers

2012 is Almost Here: Prepare Your Compliance Systems and Processes for the Physician Payments Sunshine Act
August 30th, 1pm ET/ 10am PT

Beginning in 2012, pharmaceutical, biotechnology and medical device companies will be required to monitor, analyze and report on Health Care Professional (HCP) spending as never before. There’s no time to waste – while reporting isn’t due until 2013, data must be captured throughout 2012 to ensure reporting compliance. Register Now!

Sponsor:Kru Research

Events

> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL
> Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment - September 19-20 - Washington, DC
> e-Patient Connections 2011 Conference - Sept 20-21 - Philadelphia, PA

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Capitalizing on the Outsourcing Option - New Fierce eBook

Today's Top Stories

1. Will Valeant manage to snap up Medicis?

By Tracy Staton

While announcing second-quarter earnings yesterday, Medicis Pharmaceuticals CEO Jonah Shacknai said he plans to get back to his normal schedule soon following a series of personal tragedies that kept him away from the office. Shacknai has been with his family since he lost both his 6-year-old son--who died after an accidental fall--and his girlfriend under "bizarre" and still unexplained circumstances. Now into the picture steps acquisition-hungry Valeant Pharmaceuticals, which, according to Wall Street Journal sources, has approached Medicis about a possible buyout.

The WSJ notes Medicis stock has been underperforming lately as the investigation into the girlfriend's death continues, thereby making the company a potential bargain. So, Valeant might be able to pursue its goal of dominating the dermatology market by snapping up Medicis at an attractive price. Some Medicis products--such as the acne treatment Solodyn--would be natural additions to Valeant's stable.

The timing might be right for Valeant for other reasons. During the conference call about Medicis' earnings, Shacknai sounded as if he might be open to a change, although he declined comment on the buyout talk. "At a time like this, you do a lot of introspective thinking," Shacknai said (as quoted by 10News). "We have obviously had an extraordinarily difficult time. We have undertaken some tragedies, some losses that one couldn't imagine experiencing in a lifetime."

But then again, Shacknai took great pains to thank his co-workers and board of directors for their support, adding that these difficult weeks have made him appreciate his "cohesive, capable and experienced executive team" even more. He started Medicis himself back in 1988. "I expect to be on my normal calendar in the office doing all the things I had done previously," Shacknai promised during the call.

- check out the WSJ piece
- see the 10News story
- get more from the San Diego Business Journal

This week's sponsor is Kru Research.

Reach and Engage Empowered Patients and Digital Health Consumers! www.2011epatient.com

2. Merck, Pfizer among corporate cash stashers

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=116&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_37Ad5a84dEpFo7YvTn9A" >Twitter | Facebook | LinkedIn

World markets in free fall mode; rioting in London; intransigent U.S. politicians; no wonder investors are rushing to buy gold. Next, they'll be burying cash in coffee cans in the backyard. But actually, big drugmakers are one step ahead of the cash-hoarders. They've already been squirreling their money away.

Billions of Big Pharma cash sits in figurative coffee cans around the world, waiting for executives to feel ready to spend. Some companies are saving up for the right acquisition to come along. Unfortunately for the U.S. economy, some plan to invest their money in emerging markets. Some are in the midst of share buybacks that will return a lot of their cash to shareholders as they try to soothe investors through their patent-cliff fears.

But others are just saving up. And that's natural in the current environment. "Companies feel like they don't have strong confidence that things will be better in the next year," job-market watcher John Challenger told the Star-Ledger. "Why take risks right now?"

Among the cash-rich drugmakers are Merck, which has stashed away an additional $1 billion this year. Johnson & Johnson has added another $3 billion to its stores, the newspaper reports, giving it some $27 billion on hand. Pfizer has beaucoups cash--$24 billion as of last week--especially in the wake of its $2.375 billion Capsugel sale. It's spending some of that money on shareholder dividends.

- see the article from the Star-Ledger
- read the New York Post story

Read more about: Pfizer, Merck, Johnson & Johnson, Big Pharma
back to top

3. Pharma feels threatened by U.S. austerity

By Tracy Staton

All the talk of deficit-cutting in Washington has drugmakers spooked--and has industry lobbyists working overtime. Pharma companies are fighting potential new Medicare drug rebates. Whispers about pulling the direct-to-consumer advertising tax deduction have surfaced again. As the next stage of cuts looms, who knows what other ideas Washington will come up with?

And the U.S. cost moves come amid austerity measures elsewhere, especially in Europe, where even richer countries such as Germany have targeted drug prices for reductions. So, the U.S. threats seem even more dire; after all, prices have tended to be higher there than in other countries, and that's helped drugmakers suffering from price negotiations elsewhere.

But as the Wall Street Journal Health Blog reports, analysts aren't as worried about U.S. austerity. Some of the potential cuts won't affect pharma directly: Medicare spending moves, for instance. If the government cuts reimbursements for cancer-drug therapy, oncologists will feel the hurt first. Sure, doctors may press for discounts up the line, but they can't mandate price cuts.

What's more, some drugmakers are more insulated from government cuts. Roche and Novartis, for instance, Sanford C. Bernstein analysts said (as quoted by the WSJ). Merck, Sanofi and Pfizer may also have a measure of protection.

- read the Health Blog post

Read more about: Medicare, drug prices, Big Pharma, reimbursement
back to top

4. Yervoy may soon face Roche rival

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=67&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_VbBW7RIjhBhbaVsA0kJQ" >Twitter | Facebook | LinkedIn

Roche's new melanoma treatment, dubbed Zelboraf, may get an early entry into the market. Sources tell Reuters the experimental drug could be approved as early as next week, months ahead of schedule. Apparently, some recently released data, which showed Zelboraf significantly cut the risk of death when added to chemotherapy, has inspired the FDA to move more quickly on the application.

That would mean earlier-than-expected competition for Bristol-Myers Squibb's Yervoy, the breakthrough melanoma drug approved in March. Yervoy has been a boon for BMS, coming out of the gate with unexpectedly strong sales. Its sticker price of $120,000 hasn't appeared to deter uptake one bit, at least not yet.

The two meds aren't exactly head-to-head rivals: Roche's drug targets a particular gene mutation that affects about half of all melanoma patients, so its potential market is somewhat smaller than Yervoy's, which works by stimulating patients' immune systems. In fact, they could become a melanoma-fighting cocktail if in-process trials prove the combination successful. Analysts have predicted that Zelboraf sales will peak at around $732 million, while Yervoy sales are expected to reach more than $1.4 billion.

- read the Reuters story

Read more about: Roche, Bristol-Myers Squibb, Yervoy, melanoma
back to top

5. Genentech unloads buildings to Gilead

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=105&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_5CPGejfmuM6GOgy4aR8A" >Twitter | Facebook | LinkedIn

Genentech is selling off a small piece of its Oceanside, CA, campus to Gilead Sciences. The deal involves two buildings and 55 employees, all of whom will keep their jobs, the San Diego Union-Tribune reports. That must be a relief to the Genentech folks, who well know that parent company Roche is in the middle of a cost-cutting push.

According to the Union-Tribune, Gilead will pick up a facility where about 30 scientists work on processes for producing experimental drugs. The other building is a manufacturing plant where 25 employees turn out batches of drugs for clinical trials. Gilead plans to use its new facilities to make batches of an experimental cancer drug--that work is currently outsourced to a contract manufacturer--and to develop a production process for another in-development therapy.

The terms of the deal weren't disclosed, but Gilead said in a statement it expects the transfer to close during the third quarter.

Genentech says the sale isn't the beginning of a wholesale unloading of Oceanside property. "Genentech is totally committed to Oceanside," spokeswoman Robin Snyder told the newspaper. "We want to be really clear about that."

- see the Gilead release
- get the Union-Tribune story

Read more about: Genentech, Gilead Sciences, California
back to top

Also Noted

TODAY'S SPOTLIGHT... Study: Revlimid interaction may explain side effects

A new trial found Revlimid interacts with P-glycoprotein in a way that affects blood levels of the drug, and the researchers suggest its dosage may need to be tweaked because of their finding. Report

@FiercePharma: Study finds Revlimid's interaction w/Pgp affects blood levels, so dosing might need tweaks. Article | Follow @FiercePharma

> KV Pharmaceutical wrapped up the $60 million sale of its generics unit to Zydus Pharmaceuticals and Zynesher Pharmaceuticals. Report

> Contract manufacturer Aenova plans to lease a SkyePharma manufacturing business near Lyon, France. News

> Hungary's Gedeon Richter said Genefar had been ordered to pay it $40 million for breach of contract in a dispute over the failed buyout of Polpharma. Story

> Gastrointestinal specialist Salix Pharmaceuticals saw its second-quarter profit beat analyst estimates on growing sales of its diarrhea drug Xifaxan. Item

> Endo Pharmaceuticals raised its forecast for sales and earnings as it reported Q2 income of $54.6 million on $607 million in sales. Article

> A start-up has released a software tool to help pharmaceutical companies track comments on Facebook, now that the social media site is enabling two-way communication on drugmakers' pages. Release

> Pfizer and AstraZeneca filed separate patent suits against India's Hetero Drugs, one involving a Viagra copycat and the other concerning a generic version of Nexium. Story

> Bachem said it had renewed a longstanding agreement with AstraZeneca to supply the drug Goserelin. Report

> A Maryland oncologist pleaded guilty to using a misbranded drug after administering cancer meds bought outside the U.S. Piece

Biotech News

@FierceBiotech: Is the FDA writing a recipe for the failure of biosimilars in the U.S.? Report | Follow @FierceBiotech

@JohnCFierce: So Lexicon says its Ph2 study for LX1032 showed signs of efficacy, reducing symptoms of gastro-related tumors. Item | Follow @JohnCFierce

@MaureenFierce: Several Russian cos. have establish a $113M joint venture designed to develop innovative treatments in the country. News | Follow @MaureenFierce

> Biogen, Abbott tout promising MS data from PhIIb daclizumab deal. Story

> Array adds $713M cancer drug pact with Genentech to deal roster. Report

Biotech Research News

> Gene discovered that regulates the timing of our tickers. News

> DoD gives NeoStem $1.7M to develop adult stem cells for osteoporosis. More

> Scientists discover possible genetic route to killing pain. Details

> Standford's SPARK hosts ideas so "crazy" they just might work. Story

> Researcher find faulty gene responsible for some ovarian cancers. Report

> Texas Gov. Perry supports adult stem cells after undergoing procedure. Article

Manufacturing News

> At the box office, bad boy pharma on top. Details

> UPS sees new tech, distribution models for supply chain. Story

> Roche deals API plants in SC, CO. Article

> Merck pushes pharma to top jobs-cutter. More

> NSF expands into chemical reference standards. Report

And Finally... Soy tablets do little to stave off bone loss among menopausal women, according to new research, and don't help with hot flashes, either. Report

Events

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

Saint Joseph's University offers an expanded portfolio of globally accessible AACSB-accredited programs ideal for working professionals in the pharma, biotech, medical device, diagnostics and healthcare sectors. Apply now; our September Cohort begins 9/8. Visit sju.edu/epharma or call 800-SJU-EMBA.

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

Medicaid Drug Rebate Program Summit is where manufacturers meet with all the government officials including CMS, VA, 340B, DoD, USDOJ and OIG for compliance and operations answers to healthcare reform questions. Register with a 25% off the standard rate by clicking here: www.medicaiddrugrebates.com

> Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment - September 19-20 - Washington, DC

Patients with renal impairment are at increased risk for developing drug related adverse events. In these patients drug dosage needs to be closely monitored and adjusted to reflect altered pharmacokinetics (PK) and pharmacodynamics (PD) parameters. This conference will explore ways to facilitate drug development and optimize dosing in renal impairment. Register by August 31 and SAVE $150!

> e-Patient Connections 2011 Conference - Sept 20-21 - Philadelphia, PA

Bigger than before, we are gathering experts from life sciences, public health, hospitals and also doctors and nurses to benchmark best practices for reaching and supporting digital health consumers. Save $300 with code FIERCE. Learn more at www.epatient2011.com.

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today.

> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director

We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more.

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

©2011 FierceMarkets This email was sent to nbrauchitsch@yahoo.com as part of the FiercePharma email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778. Refer FiercePharma to a Colleague

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

This exclusive offer is only available to you, and for a limited time!

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: K-V Sells Generics To Zydus For $60M

2011-08-10T00:15:00.000-03:00

Pharmaceutical Online Newsletter

Having trouble viewing this email? Visit here.

In This Issue:	08/09/11
EU GMP Annex 1:2008 And Particle Counting: Part 2 The Art Of Tablet Compression Learn More About Fume Hoods Large-Scale Cultivation Of CHO Cells	FDA Update: August 2011 Security In The Supply Chain K-V Sells Generics To Zydus For $60M Amylin And Takeda Put A Halt On Obesity Drug

Featured Articles
EU GMP Annex 1:2008 And Particle Counting: Part 2 By TSI Incorporated This article is the second in a series of three application notes to assist end users in understanding guidance detailed in EU GMP Annex 1. In this installment, detailing cleanroom and clean air device classification is covered.

The Art Of Tablet Compression By Natoli Engineering Company, Inc. Dale Natoli, vice president of Natoli Engineering Company, Inc, talks about the many factors that must be kept in the production of high-quality tablets.

Learn More About Fume Hoods By Labconco Corporation The laboratory's degree of exposure to toxic contaminants is an important consideration when selecting a fume hood. The concentration of contaminants in the actual breathing zone of the operator should be kept as low as possible.

Large-Scale Cultivation Of CHO Cells In The Stirred Single-Use Bioreactor By Sartorius Stedim Biotech The Sartorius Stedim Biotech BIOSTAT® CultiBag STR is the first and only single-use bioreactor which was engineered based on the well-established principles known from classical reusable bioreactors.

Security In The Supply Chain By FedEx Custom Critical When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.

Featured Downloads
Datasheet: High-Speed Headspace Inspection Machine The LIGHTHOUSE high-speed headspace inspection machine is an automated 100% inspection system designed to perform high-speed headspace analysis of sealed parenteral containers. The machine can be configured for 100% container closure inspection in parenteral products.

Product Sheet: Single-Use Bag In A Tank — Pharmaceutical Vessels This versatile deep drawn container is an ideal multiuse vessel with disposable bags for both the pharmaceutical and biotech applications.

White Paper: Pharmaceutical Counterfeiting — A Clear And Present Danger Pharmaceutical counterfeiting is the perfect crime. The "drug supply channel" is ill equipped to prevent it. Counterfeiting is a dangerous and growing problem. The number of counterfeiting "attacks" is on the rise, the products targeted are on the increase, and the techniques are becoming more sophisticated.

Brochure: Getinge Isolation Technology When it comes to isolation technology, there are some specific benefits derived from our modular approach and the highly specialized knowledge from our subsidiary Getinge La Calhène. These benefits are related directly to the quality of the customer's process and the economic lifecycle of the equipment.

Industry News
	K-V Sells Generics To Zydus For $60M
	Amylin And Takeda Put A Halt On Obesity Drug
	Researchers Use An Unconventional Approach To Find Leukemia Treatment
	Global GMP Guidelines Available In Online GMP Library
	FDA Approves Hospira's Gemcitabine Injection
	Gilead To Buy Genentech Biologics Process Research/Clinical Manufacturing Facility
	SP Upgrades Laboratory Benchtop Freeze Dryer
	Interest Generated By NPR Story On Promising Epilepsy Clinical Trial
	Biopharma Leaders Discuss Pharma's Future At Pharmaceutical Strategic Alliances
	Stellar Biotechnologies Announces A Strategic Agreement For Marketing And Sales With SAFC®
View more headlines



New draft guidance available for drug evaluation and research. FDA panels: Who Can Serve? Eisai NDA refused. Find out why. It's all in this month's FDA Update!

Spotlight On Cleaning (CIP, WIP, SIP)
Brochure: Steam-Thru® Connections
The innovative design of Steam-Thru Connections allows a quick and easy sterile connection between biopharmaceutical processing equipment and single-use bag and tube assemblies.

Application Note: Cleaning Glassware Contaminated With Drug Compounds Or Chemicals
The final cleaning process of equipment involved in drug compounding is crucial as the pharmacist must ensure the glassware can be reused without any carry-over of material from the previous run. This includes active ingredients and excipients.

Brochure: Clean-In-Place Systems
IPEC provides custom-designed clean-in-place systems for leading manufacturers in the food, dairy, beverage, consumer products, and pharmaceutical/biotech industries.

White Paper: A Guide To Spray Technology For Pharmaceutical Processing
Spray systems are often regarded as simple on-off valve and regulation processes. In fact, spray nozzles are precision components engineered for specific process conditions.

Product Sheet: Tornado — The Perfect High-Impact Tank Washer
The sleek, smooth exterior of the Tornado, combined with the unit's self-cleaning abilities, provides an ultra-hygienic exterior surface suitable for use in the most hygiene-conscious environments.

Product Sheet: Solujet — Low-Foaming Phosphate-Free Liquid Detergent
Solujet Low-Foaming Phosphate-Free Liquid Detergent from Alconox is a low- foaming, high-wetting detergent for maximum performance. It is phosphate-free, biodegradable, and readily disposable.
Browse the download library

Featured Multimedia

Video: Pilot Scale
Find out how Norwich can provide faster, seamless solutions in smaller scale, with reduced materials, and at a lower-cost.

Bulletin Board

Webinar: Optical Properties Of The Three Forms Of Titanium Dioxide
August 11 \| 10:30 a.m. EDT This webinar will use titanium dioxide to illustrate a number of fundamental theories and approximations, including Gladstone-Dale and Mie.

Fwd: 58 sessions, 600+ stakeholders, the biggest Cold Chain event in the world!

2011-08-10T00:14:00.000-03:00

-------- Original Message --------

Subject:	58 sessions, 600+ stakeholders, the biggest Cold Chain event in the world!
Date:	Tue, 9 Aug 2011 12:00:57 -0400 (EDT)
From:	FiercePharmaManufacturing <editors@fiercepharmamanufacturing.com>
Reply-To:	editors@fiercepharmamanufacturing.com
To:	nbrauchitsch@yahoo.com

Untitled Document

This week's FiercePharma Manufacturing is brought to you by IQPC.

The Cold Chain and Temperature Management Global Forum is fast approaching and the early bird price is about to end on August 19!

Book a full access pass< /strong> which includes the Two Day Conference, Five Workshops, Focus Day and Welcome Reception and save $2,403! Click here to register now!

The Cold Chain & Temperature Management Global Forum is among the worlds biggest and is the best place to be if you operate as an international Cold Chain specialist. Don't miss out on networking with over 600 industry stakeholders and professionals, and with 58 sessions to choose from this is your greatest opportunity to gain the skills and contacts you need to excel in your field and give your knowledge an international edge.

Book today. Call 1-800-882-8684, visit www.ColdChainPharma.com,or email cbecker@iqpc.com.au.

Regards,
Courtney Becker-James
Event Director
Cold Chain IQ (a division of IQPC)

P.S Don’t miss such a great early bird offer! Book today by calling 1-800-882-8684 or visiting www.ColdChainPharma.com!

Want to reach 15,000+ FiercePharma Manufacturing subscribers with your own message?
Contact ryan@fiercemarkets.com or call 202-824-5089.

About this email: In order to receive FiercePharmaManufacturing for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FiercePharmaManufacturing.
Click here to unsubscribe.

FierceMarkets 1900 L St. NW Suite 400 Washington, DC 20036

Fwd: G+: Improving Public Health through Vaccines

2011-08-10T00:13:00.001-03:00

-------- Original Message --------

Subject:	G+: Improving Public Health through Vaccines
Date:	Tue, 9 Aug 2011 11:01:30 -0400 (EDT)
From:	FierceVaccines <editors@fiercevaccines.com>
Reply-To:	editors@fiercevaccines.com
To:	nbrauchitsch@yahoo.com

This week's FierceVaccines is brought to you by Gerson Lehrman Group, Inc.

Dear Colleague,

Priorities for vaccine development are the subject of intense debate: should funding go to research, infrastr ucture or delivery? Find out what global vaccine experts from industry, academia and healthcare think in this survey presented by G+, part of Gerson Lehrman Group, Inc.

You will get perspectives from thought leaders on the most pressing issues, interesting approaches and critical perspectives on vaccine development. With this survey, you gain a better understanding of the challenges in improving public health through immunization science and policy.

Best Regards,

The G+ Team

Where people, ideas and new opportunities meet

About G+
G+ is a community where th e world's most active and influential professionals, academics and entrepreneurs connect. G+ provides a place for people to start new conversations, ask the important questions and propose ideas online and at in-person meetings. Join the conversation online at GPlus.com.

Want to reach 18,000+ FierceVaccines subscribers with your own message?
Contact ryan@fiercemarkets.com or call 202-824-5089.

About this email: In order to receive FierceVaccines for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FierceVaccines. Click here to unsubscribe.

FierceMarkets 1900 L St. NW Suite 400 Washington, DC 20036

Fwd: Do you know what you're missing?

2011-08-10T00:13:00.000-03:00

-------- Original Message --------

Subject:	Do you know what you're missing?
Date:	Tue, 9 Aug 2011 11:16:23 -0400 (EDT)
From:	FierceMedicalDevices <editors@fiercemedicaldevices.com>
Reply-To:	editors@fiercemedicaldevices.com
To:	nbrauchitsch@yahoo.com

Untitled Page

This week's FierceMedicalDevices is brought to you by Medical Device Daily.

You’ve been missing a lot lately! A lot of breaking news … deals in development … regulatory updates … financial forecasts …and more! Everything other medical device executives rely on every business day in Medical Device Daily to keep them on top of the latest developments in the med-tech industry!

In the past week our writers have covered the industry from every angle!

Deals roundup: FMC to acquire Liberty Dialysis, AACH for nearly $2 billion
Agreements/contracts: AmbiCom to jointly develop Wi-Fi cardiac defib application
Landmark trial establishes coiling safety for aneurysms
Washington roundup: Senate HELP committee shows ideological divide on user fees
Covidien's PUFS clinical trial data is favorable for device
New clinical research validates Calypso's Gating technology
CareFusion to distribute ResMed Stellar ventilators

We’re sending you this exclusive offer to start your Risk-Free subscription to Medical Device Daily! You'll get:

Our Medical Device Daily news report electronically delivered to you before the sun is up.
A second update every afternoon, The Medical Device Daily Midday Report, the perfect &q uot;heads-up" for what your colleagues will be discussing tomorrow, PLUS e-news bulletins on breaking developments as they happen.
Focused-intensity on sector-specifics: See our daily Extras on the niches that you need to track – CV technologies, diagnostics, cancer, orthopedics and neurology.
Historical research dating back to 2005. Search our archival database of content to spot trends, perform due diligence, locate licensing partners, and make market assessments.

Try Medical Device Daily Risk-Free for 30-days!

Want to reach 14,000+ FierceMedicalDevices subscribers with your ow n message?
Contact ryan@fiercemarkets.com or call 202-824-5089.

About this email: In order to receive FierceMedicalDevices for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FierceMedicalDevices.
Click here to unsubscribe.

FierceMarkets 1900 L St. NW Suite 400 Washington, DC 20 036

Fwd: | 08.09.11 | Merck cuts propel pharma to top of layoffs list

2011-08-10T00:12:00.000-03:00

-------- Original Message --------

Subject:	\| 08.09.11 \| Merck cuts propel pharma to top of layoffs list
Date:	Tue, 9 Aug 2011 08:57:25 -0400 (EDT)
From:	FiercePharmaManufacturing <editors@fiercepharmamanufacturing.com>
Reply-To:	editors@fiercepharmamanufacturing.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

August 9, 2011

Subscribe | Website | Jobs
Refer FiercePharmaManufacturing to a Colleague

This week's sponsor:
Fierce Custom Publishing
510(k)

Spotlight:
At the box office, bad boy pharma on top

Also Noted:
Janssen, FDA work on Doxil supply; DSM seeks contracts beyond Big Pharma; Much more...

News From The Fierce Network:
1. Boston Sci invests $37M in Irish facility
2. Knees help Smith & Nephew in Q2
3. Scientists discover possible route to killing pain

Capitalizing on the Outsourcing Option - New Fierce eBook

Events

> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC
> PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC
> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD
> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA
> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD
> BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director

New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH's revision of the 510(k) premarket notification process. Click here to download today.

Today's Top Stories

1. Merck pushes pharma to top jobs-cutter

By George Miller

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=57&ms=MzU4NTc4OAS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTQyOTAwS0&mt=1&rt=0" name="api_addthis_com_oexchange_YTN77QNZ4DGiismfTiwGQ" >Twitter | Facebook | LinkedIn

Merck ($MRK) has almost single-handedly snatched the top spot for monthly job cuts from the U.S. government, ending a 7-month streak by the public-sector behemoth. U.S. job cuts overall jumped a frightening 60% in July. The retail sector joined pharma and the government in the top three.

Merck helped push pharma to the July job-cuts apex of 13,493; the drugmaker accounts for 13,000 of that total, resulting from its previously announced multi-year force reduction. No breakdown of manufacturing versus other types of pharma jobs was available.

By contrast, pharma's cousin, the chemical industry, dropped just one-tenth the number of jobs as pharma, making it the ninth largest jobs-cutter in July. The healthcare/products sector, which includes medical devices, occupies the sixth spot with 5,193 cuts.

"What may be most worrisome is that the heaviest layoffs occurred in industries that have enjoyed relatively low job-cut levels, including pharmaceuticals, computer and retail," says John Challenger, CEO, in the report.

Adding to the pharma darkness is last week's Bureau of Labor Statistics report that the U.S. economy added 117,000 jobs in July and that the unemployment rate fell one-tenth of a percent to 9.1%. The unemployment drop, however, was driven by people leaving the labor force, so it's more representative of economic bad news that coincides with the good news of the added jobs.

Meanwhile, in India, pharma is hiring, according to the Economic Times. In fact, it's been seeing an upswing over the past four years with a growth of 13% to 17%.

- here's the CGC report
- here's the Economic Times article

Read more about: jobs, Merck
back to top

2. UPS sees new tech, distribution models

By George Miller

Healthcare changes coupled with increasing and changing regulatory requirements are among factors accelerating the pace of supply chain change among pharma, biotech and medical device companies. Many are turning to new technology to keep up, according to UPS's fourth annual Pain in the Supply Chain report.

Through phone surveys this spring of nearly 250 supply chain execs in the U.S., Europe and Asia (compared with 150 U.S.-only respondents in the 2010 report), UPS is seeing "a complete rethinking of supply chains," says John Menna, director for healthcare strategy, in a phone interview. Supply chain executives are looking for "step changes, not incremental improvements. They have an increasing appetite to do things differently."

Menna's observation of the accelerating pace of change comes not just from respondent answers to survey questions, but also from the types of analyses they undertake and the changes they're making now, he says.

The survey finds 86% of respondents saying they will turn to new technologies as an investment strategy within the next three to 5 years, with 72% saying they have made such investments in the last 18 months. "They're looking at tracking technologies," says Menna, "radio frequency identification tags, for example, and integration of corporate systems with UPS tracking systems."

The respondent company universe is roughly a two to one mix of pharma/biotech companies and medical device companies, respectively.

Also on the tech shopping list: sensing devices, warehouse management software and order-to-cash systems. "They're looking for anything that will make it easier for product ordering, as well as newer functions for supply chain planning," he says.

On the non-tech side, the survey finds changes in distribution channels and models a tactic for achieving greater efficiencies. Some 63% of pharma/biotech respondents say they've used this strategy--including more direct shipments to providers, retailers and patients, as well as increased use of wholesalers and distributors--over the past 18 months. And 81% say they plan to do so in the next three to 5 years.

One distribution model change is a form of logistics handover, in which a drugmaker relinquishes post-manufacturing ops to a logistics provider. One example is the growing collaboration between Merck and UPS. Others involve DHL's Exel unit, which has relationships with Bristol-Myers Squibb and Pfizer.

- here's the release
- see the report (pdf)

Read more about: Ups Supply Chain
back to top

3. Roche deals API plants in SC, CO

By George Miller

Roche Carolina has returned money given by the state of South Carolina to keep open its 300,000-square-foot facility in Florence. The drugmaker announced late last year that it might close the plant. But it was apparently swayed by a $500,000 state incentive and said in June that it would keep the plant open for "at least a few more years," according to SCnow.com.

But Roche returned the money late last week, and officials hope the funds can be used elsewhere (or by Florence itself in the future). The plant, which employs about 300, manufactures the active ingredients for Tamiflu and Xeloda, a chemotherapy drug.

The FDA listed Tamiflu for oral suspension in short supply last month and in January.

And in Boulder, CO, last week, International Chemical Investors Group said it plans to acquire Roche Colorado, which includes a pharma production facility. Some 265 development and manufacturing personnel staff the site, which Roche bought in 1994.

ICIG will operate the site as part of its Corden Pharma unit.

Under terms of the transaction, Corden will supply Roche with APIs currently made at the facility. It aims to meet the drugmaker's demand for "commercial scale peptides and other medicinal compounds," according to the Boulder County Business Report. The workforce is expected to remain intact.

- see the SC story
- here's the Boulder story

Read more about: Roche, Manufacturing Plant
back to top

4. GSK tests wireless water monitoring at plant

By George Miller

Sustainability-minded GlaxoSmithKline ($GSK) is simultaneously testing two technologies to enhance water use in an API manufacturing operation. The drug giant has combined wireless networking with pressure and flow transmitters at its plant in Cork, Ireland.

The transmitters from Emerson Process Management's Smart Wireless platform are attached to two new storage tanks connected with the facility's water system. The tanks were added when the API operation outgrew its water storage facility. Via the new tanks, the transmitters monitor data throughout the plant and send it to GSK engineers. In addition to studying water usage, the engineers are testing the wireless technology in hopes of being able to create a network that allows for additional process instrumentation, according to an Emerson Process Management case study.

The network currently has 10 Smart Wireless devices: 6 pressure transmitters, two flow transmitters and two level transmitters. Flow data are transmitted every 30 seconds and pressure and level data every 300 seconds to a Smart Wireless Gateway on the roof of the plant's control room building. The wireless system is integrated with GSK's DeltaV utility-control automation system, where it can be accessed by plant operators.

- here's the case study

Special Report: The 12 greenest companies in biopharma

5. NSF to provide chemical reference standards

By George Miller

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=68&ms=MzU4NTc4OAS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTQyOTAwS0&mt=1&rt=0" name="api_addthis_com_oexchange_kQnEMrQuLIVGorwZr6yQg" >Twitter | Facebook | LinkedIn

Nonprofit NSF International is launching the NSF Reference Standards Program, through which it will provide chemical reference standards as a service to drugmakers. The new program augments the documentary standards service it already provides.

The chemical reference standards, which are used for comparisons that demonstrate the identity, purity, quality and strength of the subject drugs and ingredients, will be traceable to official U.S. and European pharmacopeial standards, according to an announcement. The program will focus on developing reference standards that are in demand by global customers in the pharma and health supplement industries, says Steven Lane, the program's general manager, in an email. One indication of the global scope of the service is the announcement's availability in Chinese as well as English. Lane says that reference standard pricing will be "favorable" relative to other U.S. and European pharmacopeial standards.

Among characteristics of the NSF reference standards: They will be verified to conform to FDA and European Directorate for the Quality of Medicines & HealthCare regulatory requirements; produced and tested in compliance with current good manufacturing practices; and tested independently by a minimum of three collaborating laboratories.

- here's the announcement

Also Noted

TODAY'S SPOTLIGHT... At the box office, bad boy pharma on top

In another blow to pharma's tattered image among the public, Rise of the Planet of the Apes makes drug developer Will and Big Pharma the agents of unprecedented disaster. "Will is a brilliant, but cold pharmaceutical scientist who, instead of finding a cure for Alzheimer's disease, starts the cataclysmic extinction of man." Alas, it topped the weekend box office receipts in North America at $54 million, more than double the take of second-place The Smurfs. Review | Box Office Rundown

> Janssen, maker of chemotherapy drug Doxil, says it's "working closely" with the FDA on a plan to get the drug to doctors as soon it becomes available, which it expects to be in late August. Story

> DSM seeks a CMO partner to help it target work in addition to what it receives from Big Pharma. Report

> Vaccine maker MedImmune has opened a second manufacturing plant in Frederick, MD, to expand production capacity. Item

> Abbott Labs will enjoy "significant savings on imports of products from offshore," after its Temecula, CA, plant was admitted to a foreign trade zone. Article

> More demand-driven supply chains can help Big Pharma make the leap from traditional make-to-stock production to more efficient make-to-demand. News

> An unnamed Belgian drugmaker is using RFID and bar code technology to track more than 70,000 bags of products annually as they undergo testing. Story

> Asian distributor Zuellig Pharma has teamed with business-process specialist ADEC Solutions to create a pharma/healthcare knowledge- and business-process outsourcing service provider. ADEC/Zuellig release

> Early results from the first few years of FDA dietary-supplement manufacturing inspections show some common GMP violations. Story

> CMO SynCo Bio Partners has expanded its aseptic filling facility, equipped to fill and lyophilize biopharmaceuticals, including monoclonal antibodies, nucleic acids, proteins, polysaccharides, aluminum-containing vaccines, RNA and live biotherapeutics for clinical and market supply. Item

> AccuDial liquid OTC medications have a two-part label that allows parents to administer milliliter-precision doses based on a child's weight, rather than the more common dosing based on age. Story

Events

> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC

This Conference offers a unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. FDA speakers provide updates on the current state of efforts impacting global regulatory strategies. Industry professionals will present case studies on how they employ global strategies in their daily processes. Click here.

> PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC

This workshop focuses on the device design validation requirements of FDA's Quality System Regulation and the international harmonized quality standard ISO 13485:2003 which may be applied during the life-cycle of a combination product. Click here.

> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD

This interactive forum will closely examine the latest developments, preparation and use of inspection standards and practical aspects of manual and automated methods along with the regulatory and compendial requirements that govern them. Click here.

> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA

PDA, ISPE, the FDA and EMA have created a joint conference dedicated to teaching the principles of ICH Q10. This will be a unique opportunity to learn principles from companies that implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model. Click here.

> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD

This conference will gather industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces. The agenda will include presentations from regulatory and industry representatives globally. Click here.

> BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA

BPI is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing. This conference is where challenges are explored, solutions are uncovered and opportunities are developed. Learn more, view the agenda or download the brochure.

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director

Editor: George Miller. Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

Unsubscribe from FiercePharmaManufacturing

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: | 07.25.11 | Will pharma fight Express-Medco merger?; Forest taps lobbyist to aid Solomon

2011-07-26T02:29:00.000-03:00

-------- Original Message --------

Subject:	\| 07.25.11 \| Will pharma fight Express-Medco merger?; Forest taps lobbyist to aid Solomon
Date:	Mon, 25 Jul 2011 12:36:02 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

July 25, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsors:
Drexel University
INC Research
An Expert Briefing: Biotechnology 101

Spotlight:
Teva gets a taste of its own patent medicine

Also Noted:
Dr Reddy's to buy Russian drug portfolio; Glenmark to ramp up on Salix HIV drug; Much more...

News From The Fierce Network:
1. Data analysis reveals adverse drug combo
2. Nonprofit to gain from Vertex's CF drug
3. St. Jude to cut 450 Swedish jobs

This week's sponsor is Drexel University Online.

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Webinars

Events

> Skill-building and Summer Fun in Boston!
> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years
> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

This week's sponsor is INC Research.

Today's Top Stories

1. Will pharma fight the Express-Medco deal?

By Tracy Staton

As if drugmakers didn't have enough pressure on sales from the upcoming patent cliff, they're now facing the threat of a pharmacy benefits merger that would turn two 900-pound gorillas into one King Kong of pricing power. As Dow Jones reports, pharma companies aren't cringing in fear just yet--at least not in public--but they might soon grab some burning torches and make a run at antitrust regulators, to see if that can keep the monster away.

Since Express Scripts announced last week that it planned to buy Medco Health Solutions for $29-plus billion, drugmakers have been taciturn about the possible threat to U.S. drug prices. Those who have spoken have tended to downplay the risk. Eli Lilly CFO Derica Rice, for instance, said the company could keep its negotiating power simply through the advantages its products offer over generics. (Never mind that the company's recent earnings clearly suffered from generic competition; that's another story.)

But industry experts and analysts have a different story to tell. BioPharma Alliance's Michael Luby, for instance, told Dow Jones that the Express/Medco combo would offer "extraordinary purchasing power for the combined company to leverage with pharmaceutical companies." And Morningstar analyst Damien Conover said the companies might raise antitrust concerns with regulators; that wouldn't be much of a stretch, given that the word "antitrust" was already all over the media coverage when Express and Medco announced the deal.

Price cuts in European countries such as Germany and Spain have already been dogging Big Pharma. In the U.S., drugmakers have escaped government price negotiation, at least so far, though companies have discounted their drugs for Medicare and are subject to mandatory Medicaid rebates. Pharma has, of course, spent lots of time, money and effort lobbying against U.S. government pricing pressure.

Now, the threat comes from the private sector. Besides the obvious danger of sheer size, the planned PBM merger involves at least one company, Medco, that hasn't been shy about subjecting drugs to its own comparative-effectiveness research--something the federal government has had difficulty embracing for political reasons. Pharma isn't wild about the idea. So, if the FTC doesn't start getting letters from drug CEOs, we'd be surprised.

- read the Dow Jones story

An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT

Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today.

2. Forest taps lobbyist to aid Solomon at HHS

By Tracy Staton

Forest Laboratories is stepping up its fight on behalf of CEO Howard Solomon. In the face of threats that Solomon would be barred from doing business with the federal government, the company has tapped former Sen. John Breaux for help. A Democrat from Louisiana, Breaux co-headlines a lobbying firm with former Senate Majority Leader Trent Lott, and one of his specialties is healthcare issues.

Several months ago, the Department of Health and Human Services notified Solomon that he might be excluded from government business, a move that would prevent Forest from capturing Medicare and Veterans Administration sales so long as Solomon is associated with the company. Forest immediately pledged its support in Solomon's fight against exclusion, noting that, while the company had pleaded guilty to marketing an unapproved drug and settled an off-label marketing investigation with the U.S. Justice Department, Solomon himself had never been accused of wrongdoing.

In going after Solomon personally, HHS is making good on threats to hold pharma executives accountable for their companies' misdeeds, perhaps even if those executives weren't directly involved in wrongdoing. In spite of several Justice Department settlements in the hundreds of millions of dollars--as well as a couple in the billions--federal officials have worried that such deals aren't enough to deter bad corporate behavior.

Solomon's problems with HHS have spawned problems for Forest, most notably a proxy fight with Carl Icahn and his investment funds. Icahn's group has nominated new members for the company's board, and it has sued the company for more information about Solomon's status. Clearly, Forest thinks it needs help fighting off the dragons, or it wouldn't have hired Breaux.

- read the news from The Hill
- get more from Pharmalot

Read more about: Forest Laboratories, Howard Solomon
back to top

3. Vietnam to test GSK drug for contaminants

By Tracy Staton

In the wake of a recall in Hong Kong, GlaxoSmithKline's ($GSK) antibiotic Augmentin is now facing testing by regulators in Vietnam. The Drug Administration of Vietnam says it will collect samples of the drug to test for plasticizers, the chemicals found in trace amounts by Hong Kong officials. Vietnam has also asked GSK to work with distributors to collect samples.

Hong Kong has pulled two Augmentin products: a powdered form that's reconstituted into a liquid for dosing and a 375 mg pill version. Authorities there said they had found plasticizers in both products; the pill version contained di-2-ethyl hexyl phthalate (DEHP) and diisodecyl phthalate (DIDP). The 375 mg pill is no longer imported into Vietnam, authorities there said, although other pill strengths and powdered versions are.

At the time of the Hong Kong recall, GSK and health officials there emphasized that the amounts of plasticizer found weren't likely to cause harm to humans if they were taken at the proper doses. But Hong Kong is still mulling legal action against the drugmaker. Meanwhile, GSK is conducting an internal investigation to determine the source of the chemicals, because they are not used to manufacture the antibiotic products.

- read the story in Thanh Nien News

Read more about: Augmentin, Vietnam, GlaxoSmithKline, drug recall
back to top

4. Roche, Novartis cancer meds win EMA nod

By Tracy Staton

Roche and Novartis both got a boost from European authorities, who are recommending new uses for their targeted cancer drugs. Roche got the nod from European Medicines Agency to market Tarceva for patients with a particular genetic strain of non-small cell lung cancer, while Novartis' Afinitor won backing for use in patients with advanced pancreatic neuroendocrine tumors.

Both new indications will need a final OK from the European Commission, but as Reuters points out, the EC typically follows through on these recommendations within a couple of months.

Tarceva already is a big seller for Roche, with $1.58 billion in 2010 revenues, but the new use promises to broaden its marketing appeal further. The new indication would cover Tarceva as a first-line treatment for NSCLC that has tested positive for a genetic mutation affecting the advanced epidermal growth factor receptor. It's already approved as a second- and third-line treatment for lung cancer with or without the mutation.

Afinitor, on the other hand, is still a sub-$1 billion drug, but Novartis ($NVS) hopes that building up new indications for the drug will eventually push it into blockbuster territory. As Reuters notes, the drug targets a protein that regulates cell division and metabolism, as well as blood-vessel growth. The new indication would allow Afinitor to be marketed for NET tumors that are inoperable or have metastasized. It's already approved for kidney disesase, and recent data have raised hopes that it could win a nod for use in breast cancer. Novartis plans to file for that indication by year's end.

- read the Reuters news
- get more from InPharm

Read more about: Novartis, Roche, lung cancer, Tarceva
back to top

5. J&J's blockbuster hopefuls get EMA rec

By Tracy Staton

Johnson & Johnson ($JNJ) saw its stable of new drugs strengthened at last week's meeting of European regulators. The European Medicines Agency's drug-approval panel backed its new prostate cancer drug Zytiga and its new hepatitis C treatment Incivo. As Bloomberg notes, both are presumed blockbusters that could help give J&J sales a multibillion-dollar boost.

Zytiga won approval in the U.S. earlier this year, as did Incivo, which is sold in that market by Vertex Pharmaceuticals ($VRTX) under the brand name Incivek. Citigroup's Matthew Dodds has tagged peak sales of Zytiga at $1.1 billion by 2015, while Incivo could hit $1.4 billion by the same year, Bloomberg notes.

The final European approval will have to come from the European Commission, but J&J is expected to be able to launch the drugs on the continent by the end of this year. In fact, J&J's Janssen Pharmaceutical is raring to go; Incivo medical leader Jim Witek told Bloomberg that Incivo could be on the market within days of the EC's blessing.

- read the Bloomberg story

ALSO: Johnson & Johnson (JNJ)'s Simponi, a treatment for rheumatoid arthritis, wasn't approved by U.S. regulators as a way to inhibit the progression of damage from the disease. Report

Also Noted

TODAY'S SPOTLIGHT... Teva gets a taste of its own patent medicine

Teva Pharmaceutical Industries, the generic-drug giant that made a business out of challenging the valuable patents of Big Pharma, is getting a taste of its own tactics as generics makers target its multiple sclerosis drug Copaxone. And it's adopting the same defensive tactics that branded drugmakers have employed against it for years. Report

@FiercePharma: Merck amps up in China with Simcere JV. Report | Follow @FiercePharma

> India's Dr Reddy's Laboratories agreed to buy JB Chemicals & Pharmaceuticals' drug prescription portfolio in Russia and several other countries in an approximately $34.9 million deal. Report

> Salix Pharmaceuticals has updated its supply agreement with India's Glenmark Pharmaceuticals to increase manufacturing of its HIV-associated diarrhea drug, Crofelemer. Article

> According to results from a Japanese study, Bayer's Xarelto blood thinner wasn't associated with a higher risk of bleeding for irregular-heartbeat patients compared to the previous standard of care, warfarin. Item

> GlaxoSmithKline sued Watson Pharmaceuticals to protect the patent on its prostate drug Jalyn, which Watson is seeking FDA permission to copy. News

> Victory Pharma, a specialty pharmaceutical company with operations in Cary, NC, and San Diego, will eliminate 179 positions when the sale of its assets to Shionogi wraps up. Report

> Valeant Pharmaceuticals got Canadian approval for its sleep drug Sublinox, to be marketed in a joint venture with Meda. Release

> Sanofi said it has appointed Greg Irace to the role of senior vice president, global services; he is currently CEO of Sanofi's U.S. operations. Report

Biotech News

@FierceBiotech: Bristol-Myers snapping up Amira Pharma for $325M. Item | Follow @FierceBiotech

@JohnCFierce: Government pledging to overhaul rules on human research. From the NYT. Story | Follow @JohnCFierce

@RyanMFierce: John Halamka has a very lucid explanation for why Harvard Med School needs a full time CIO, NGS demands, storage, etc. Blog post | Follow @RyanMFierce

@MaureenFierce: FDA rejects new use for J&J immune disorder drug Simponi. News | Follow @MaureenFierce

> Government officials try to simplify the rules on human research. Article

> Analysis: Grim stats on CNS drugs demand fresh approach to development. Report

> Medicis inks $58M dermatology pact with India's Lupin. Piece

Biotech IT News

> Harvard Med School CIO Halamka exiting big job. Story

> Biomax Informatics expands deal with Royal DSM. More

> Mayo Clinic eyes future trial recruitment with health data exchanges. Report

> Bioinformatics upstart Intervention Insights secures $7.2M. Article

Medical Device News

> Nevro lands $58M for pain devices. More

> St. Jude to cut 450 Swedish Jobs. Report

> King's College spins out Centron Diagnostics. Story

> Imperial Innovations invests $6.5M in Stanmore Implants. Article

> Drew Medical's Dinkel banned from Medicare business. News

And Finally... Arthrosclerosis, which causes heart disease, can also result in dementia, researchers found. Report

Webinars

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Join us Tuesday, July 26th, 1 pm ET / 10 am PT as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process. Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more. Register Today

Events

> Skill-building and Summer Fun in Boston!

Boston offers exciting summer options for visitors of all ages. You could see a movie in the local park, listen to a concert on City Hall Plaza, or learn to paint on the waterfront. So why not explore Boston in August and build your professional skills at the same time?

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA

Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

With a surge in remote monitoring devices, mHealth developers are clamoring to build M2M applications that can transmit patient data in real time. Download this whitepaper today to learn more about developing apps for pharma-manufacturing and beyond. Download this white paper today!

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

Jobs

> Regional BD Director

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: | 07.22.11 | Merck amps up in China; J&J board blames woes on middle managers

2011-07-26T02:26:00.000-03:00

-------- Original Message --------

Subject:	\| 07.22.11 \| Merck amps up in China; J&J board blames woes on middle managers
Date:	Fri, 22 Jul 2011 12:10:32 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

July 22, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsors:
Myriad RBM, Inc.
An Expert Briefing: Biotechnology 101

Spotlight:
AZ: No plans for follow up on Brilinta-aspirin link

Also Noted:
Teva to shutter Montreal plant, cut 340 jobs; Baxter boosts earnings, raises outlook; Much more...

News From The Fierce Network:
1. Pfizer commits $100M to Mission Bay project
2. BMS snapping up Amira Pharma for $325M
3. FDA panel votes in favor of Sapien valve

This week's sponsor is Myriad RBM, Inc.

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Webinars

Events

> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR
> Skill-building and Summer Fun in Boston!
> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years
> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Today's Top Stories

1. Merck amps up in China with Simcere JV

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=17&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_2jvI6CNyjsOW8y1qOUMovw" >Twitter | Facebook | LinkedIn

Merck is expanding its tent in China with another partnership, this time with Simcere Pharmaceutical Group. It's a drug follow-up to the company's vaccines partnership with Sinopharm, which began with a deal to sell Merck's human papillomavirus vaccine. That link-up was intended to spread to other shots and, possibly, prescription meds.

The Simcere joint venture, still subject to final conditions, will focus at first on branded drugs for cardiovascular and metabolic diseases, with each company contributing existing products for manufacturing and marketing. On the CV side, think Zocor and Cozaar from Merck, and Simcere's Shufutan (Crestor), which it markets under license. In the metabolic area, the partnership will start with the diabetes drug Januvia, aiming to "maximize access" in a country that's facing a growing problem with that disease.

The partnership will also work on the development side of things, but the details on that are sketchy at this point. "This partnership is another step forward in Merck's strategy to grow our business in China and is fully aligned with the Chinese government's goal to increase access to quality products," Adam Schechter, Merck's president of global human health, said in a statement.

China, of course, is one of the world's most promising markets for drugmakers. Pharmaceutical sales there are enjoying double-digit growth, and the market is expected to reach $73 billion by 2013. Merck is aiming to boost its sales in the country by more than 20% per year, but for that, it will have to contend with virtually every Big Pharma competitor.

- get the release from Merck
- read the RTT News story

2. J&J board blames woes on middle managers

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=27&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_edN9MSDzwSdsxCKKjM9nw" >Twitter | Facebook | LinkedIn

Johnson & Johnson's quality control problems were caused by mismanagement at McNeil Consumer Healthcare, a board committee investigation found. The report places the blame for a rash of recalls--not only the massive withdrawals of McNeil products, but also substandard prescription drugs, devices and contact lenses--squarely on lower-level execs, letting senior executives off the hook, Bloomberg reports.

McNeil quality-control staff and production folks didn't play well together, and the division suffered from "an emphasis on production volume" rather than on compliance, the panel's report states. J&J's consumer division leadership should have watched McNeil more closely, especially as it worked to integrate Pfizer's consumer health division, the committee said. "[S]ome McNeil employees may have lost focus and commitment to maintain quality standards," Bloomberg quotes.

True, integrating the Pfizer operation was a big job, with thousands of new products to handle. New manufacturing lines were put in at Fort Washington, PA, and Las Piedras, Puerto Rico--both factories that would end up on the FDA's hit list for quality lapses. And McNeil's management suite had a revolving door at the time, the report notes, so company leaders didn't know what was happening at the plant level.

The board committee praised J&J execs for acting quickly once they discovered the manufacturing issues. It also denied any red flags or "systemic failure" overlooked by top management--two allegations raised by shareholder lawsuits attempting to hold executives and board members accountable.

But the report also fingers restructuring at J&J for making the problem worse: Quality and compliance staff were cut by 35%, and the corporate types lost the authority to show up unexpectedly to audit subsidiaries' operations. Plus, a "virtual hiring freeze" hampered McNeil's ability to hire quality-review staff. Someone in J&J's senior management obviously signed off on those decisions. And while top management may not have known the depth of McNeil's problems, one might argue that they should have known. Absolving J&J's leadership of responsibility for the widespread problems may help dispose of shareholder claims, but it won't force them to do the tough soul-searching required to make a company better.

- read the Bloomberg coverage
- get more from Pharmalot

Read more about: Johnson & Johnson, quality, McNeil
back to top

3. FDA joins Multaq review, reveals prelim data

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=87&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_UdVqkL6Mp0QmDATnsphNA" >Twitter | Facebook | LinkedIn

FDA has joined the Multaq review effort. The agency said that it is analyzing data from the recently halted trial of Multaq in patients with permanent atrial fibrillation. Sanofi stopped that 3,000-patient study two weeks ago when "a significant increase in cardiovascular events" cropped up in a data analysis.

The FDA, however, revealed some actual, preliminary numbers from that study, known as PALLAS. According to the agency, 16 patients in the Multaq arm died, compared with 7 in the placebo group. The number of patients who died from cardiovascular causes, or had a heart attack, stroke or embolism, was 32 in the Multaq group, versus 14 with placebo. Thirty-four Multaq patients were hospitalized with heart failure, compared with 15 placebo patients.

European regulators are already reviewing the drug; they say they'll release their results in September. In announcing its review, FDA said that a critical question is whether the "unfavorable results of the PALLAS study" apply not only to patients with permanent atrial fibrillation, but also to patients with temporary versions of fibrillation. Multaq is FDA-approved for use in patients with paroxysmal atrial fibrillation and atrial flutter.

Sanofi says "the benefit-risk profile remains positive" for the approved use, the New York Times reports, but advised doctors never to prescribe it for permanent atrial fibrillation. As for FDA's advisory experts, one who voted for Multaq's approval called the PALLAS data "concerning," while Public Citizen's Sidney Wolfe, who voted against, said the drug was "really too dangerous," the Times reports.

- check out the FDA statement
- read the news from Reuters
- get the NYT piece
- see the MedPage story

Read more about: FDA, Sanofi-Aventis, Multaq
back to top

4. EMA wants Actos warning, rules on Chantix

By Tracy Staton

Regulators on both sides of the Atlantic issued a slew of decrees about drug safety, weighing in on everything from flu vaccine to bone drugs to Pfizer's smoking cessation med Chantix. The biggest decision came from the Europeans, which decided to leave the Takeda diabetes drug Actos on the market, but added strong warnings about possible links to bladder cancer.

France and Germany have both halted sales of Actos, which belongs to the same class of diabetes remedies as the GlaxoSmithKline drug Avandia. While the European Medicines Agency decided to withdraw Avandia on its cardiovascular risks, it won't restrict use of Actos, which has been tagged with increasing the risk of bladder cancer. The risk could be minimized by proper patient selection, the EMA said. FDA recently added new cautionary language to the drug's label about the possible cancer link.

FDA, for its part, reported on an ongoing review of bone drugs known as bisphosphonates; the agency has been looking at some conflicting studies of the drugs' potential links to esophageal cancer. For now, the agency said, the benefits appear to outweigh the risks, but an FDA advisory panel will be discussing their safety at a meeting in September. The class includes such popular meds as Merck's Fosamax and Roche's Boniva.

Meanwhile, an EMA committee said it had determined that Chantix's benefits outweigh its risks. New questions about the drug were raised by a meta-analysis that found an increase in cardiovascular problems, such as heart attack and stroke, in patients using the drug. The EMA's Committee for Medicinal Products for Human Use found some weaknesses in that analysis, including the exclusion of studies in which no patient experienced a cardiovascular event, Pharmalot reports.

Finally, the EMA wants GlaxoSmithKline to update its label on the pandemic flu shot Pandemrix, after finding a link between its use in young people and the rare sleeping disorder narcolepsy. The agency said the CHMP has recommended that people under 20 should avoid Pandemrix unless they have no access to seasonal flu vaccines and they're at high risk of complications from H1N1.

- read the Reuters news
- see the Bloomberg piece
- get more from Pharmalot
- check out the Dow Jones story

Read more about: GlaxoSmithKline, Pfizer, Actos, Chantix
back to top

5. Lilly eyes vet assets; Pfizer says all or nothing

By Tracy Staton

Might Eli Lilly ($LLY) emerge as a buyer for Pfizer's animal health business? CFO Derica Rice told Lilly investors that the company is keeping an eye on Pfizer's plans for the unit, which may be sold or spun off. If Lilly likes any of the available assets, it would pursue them, Rice said.

When asked about that pledge, Pfizer said that it doesn't envision selling off the animal health business in pieces. The whole unit would be sold or spun off, spokeswoman Joan Campion told Bloomberg. "While we are evaluating a variety of options including a sale, spin-off or other transaction, we believe we will favor one overall option rather than dividing assets and business operations," Campion told the news service.

Pfizer has tagged its animal health and nutrition units for disposal, so it can return cash to shareholders and focus on pharma development. The units could bring in more than $20 billion; the animal health unit alone had 2010 sales of $3.48 billion, Bloomberg notes. A deal of that size could be beyond Lilly's ken; CEO John Lechleiter has repeatedly said he's not in the market for a big buyout.

Pfizer will be weighing its options for the animal health unit for at least a year, Campion said.

- read the Bloomberg story

Also Noted

TODAY'S SPOTLIGHT... AZ: No plans for follow up on Brilinta-aspirin link

AstraZeneca doesn't plan to conduct a clinical trial to confirm that aspirin dosage caused a geographic discrepancy in the performance of its newly approved heart drug Brilinta. Some analysts had speculated such a trial might strengthen the image of the brand in the U.S., even though the company has not been asked to do so by regulators. Report

@FiercePharma: Now that Brilinta's approved, AZ has to sell it. Story | Follow @FiercePharma

> Teva Pharmaceutical plans to shut down a Montreal plant acquired as part of its Ratiopharm buyout, having failed to find a buyer for the facility; the move will put 340 employees out of work. Report

> Baxter International reported higher-than-expected quarterly earnings, led by strong sales at its bioscience units, and raised its outlook for the full year. Report

> Prescriptions for Abbott Laboratories' Niaspan cholestserol drug fell 5% 6 weeks after a study that said the medicine failed to prevent heart attacks. Article

> Teva Pharmaceutical Industries said it settled patent litigation related to its generic versions of the Novartis blood-pressure drug Lotrel. News

> Express Scripts' takeover of Medco Health Solutions may fuel acquisitions of specialty pharmacy benefit managers by rivals seeking to gain enough size to negotiate lower prices with drugmakers. Report

> An FDA advisory panel backed an additional use of Johnson & Johnson's top-selling drug Remicade in pediatric patients, but said more data is needed about a rare cancer found in some young people treated with Remicade and similar drugs. Piece

> Danish drugmaker Lundbeck expects annual royalties from Japanese sales of its antidepressant Lexapro to peak in 6 or 7 years at above 500 million Danish crowns ($95.2 million). Item

> Shares of AmerisourceBergen fell 5% to $39.78 on worries that the company's lucrative contract with Medco Health Solutions could be in jeopardy now that it is being acquired by Express Scripts. News

> The FDA declared three pseudoephedrine-based medicines used to treat colds and allergies as controlled drugs. Report

> All strategic suppliers to Johnson & Johnson will need at least two publicly-reported sustainability goals under a new initiative by the healthcare giant. Report

Biotech News

@FierceBiotech: Roche could get groove back with potential early approvals of cancer drugs. Article | Follow @FierceBiotech

@JohnCFierce: The semagacestat Alzheimer's drug story demos again how little we know about consequences of messing with believed triggers. Item | Follow @JohnCFierce

@RyanMFierce: Translational research is very difficult. Forbes lists the ways. Article | Follow @RyanMFierce

@MaureenFierce: Experiments that insert human genes, cells into animals need rules to ensure they don't create 'monsters.' Article | Follow @MaureenFierce

> Bristol-Myers snapping up Amira Pharma for $325M. More

> Pfizer commits $100M to Mission Bay project. Story

And Finally... Lloyds pharmacy will open a pilot "health village" in a London retail center as part of its plan to become an all-round healthcare provider. Report

Webinars

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Events

> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR

The world's leading clinical drug development and outsourcing event returns to Latin America for its 2nd Annual Partnerships in Clinical Trials Latin America meeting- bringing its unique formats, high-level strategic discussions, and unparalleled networking to Sao Paulo, Brazil. Visit www.PCTLA.com.

> Skill-building and Summer Fun in Boston!

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

Jobs

> Regional BD Director

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: | 07.11.11 | Jimenez: Novartis' desire for deals to return soon

2011-07-17T22:31:00.002-03:00

-------- Original Message --------

Subject:	\| 07.11.11 \| Jimenez: Novartis' desire for deals to return soon
Date:	Mon, 11 Jul 2011 13:12:12 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

July 11, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsors:
INC Research
eKnowledgeBase
An Expert Briefing: Biotechnology 101
Thomson Reuters

Spotlight:
Teva, Merck agree to 2017 date for Vytorin copies

Also Noted:
GSK wins FDA nod on Boostrix use; India's Orchid ordered to close API plant on pollution; Much more...

News From The Fierce Network:
1. Medtronic advises doctors of pump problem
2. QIAGEN amends offer for Cellestis
3. IBM cloud aids fight against superbugs

This week's sponsor is INC Research.

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Webinars

Events

> BioImmersion: Biotech for the Non-Scientist - July 13-15, 2011 - Chicago, IL
> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR
> Skill-building and Summer Fun in Boston!
> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

This week's sponsor is eKnowledgeBase.
	FREE two-week trial. Searchable online database providing access to verified company and drug competitive intelligence. Stay current on company, product, and pipeline performance/activity plus FDA actions, brand representation, and clinical initiatives. Click here.

Today's Top Stories

1. Valeant snaps up Sanofi's Dermik for $425M

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=117&ms=MzUzODcxNwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTExNTgxMDUwS0&mt=1&rt=0" name="api_addthis_com_oexchange_GB7wwdA5P9Sd7HQWWPr40A" >Twitter | Facebook | LinkedIn

Sanofi ($SNY) has agreed to offload its Dermik skincare business to Valeant Pharmaceuticals ($VRX) in a $425 million deal that gives the Canadian drugmaker brands such as the acne treatment BenzaClin and wrinkle-filler Sculptra. It also allows Sanofi to focus more tightly on what CEO Christopher Viehbacher (photo) calls its "growth platforms."

The cash deal brings to fruition Sanofi's previously announced intent to divest the dermatology business with operations concentrated mostly in North America. "This divestiture allows us to rationalize our portfolio and improve focus on our core businesses," Viehbacher said in a statement.

Despite the "focus-on-our-core" language in that announcement, the Dermik sale isn't a divestment á la Bristol-Myers Squibb, which has pared away its non-pharma units to focus solely on innovative meds, or even a Pfizer-esque spinoff designed to feed investors' desires while shedding a big chunk of peripheral business. Sanofi, along with rivals such as GlaxoSmithKline and Novartis, remains in the diversification-is-good camp, with operations in animal health, consumer healthcare, generic drugs, et al, all intended to balance out the vagaries of today's prescription drug business.

For Valeant, the Dermik business is yet another to add to its quiver. Dermik has a manufacturing plant in Quebec, handy for the Canadian-based Valeant, and its dermatology drugs will help beef up the company's franchise in that area. While the other products are focused in North America, the aesthetic side of the business--a.k.a. Sculptra--has a global presence, giving Valeant a geographic footprint to build upon. "Dermik's assets, both in the medical and aesthetic therapeutic areas, provide us with exciting opportunities to leverage our combined portfolios in our current markets as well as options to expand Valeant's presence to other territories," CEO J. Michael Pearson said in a statement.

- see the release from Sanofi
- check out the Valeant announcement
- get more from Reuters

ALSO: Sanofi said Lemtrada, the experimental multiple sclerosis drug acquired through the purchase of Genzyme, helped patients more than Merck KGaA's older medicine Rebif in a key study. Report

2. CEO: Novartis' desire for deals to return soon

By Tracy Staton

Novartis ($NVS) could soon be back on the acquisition trail. CEO Joe Jimenez (photo) told Swiss newspaper Aargauer Zeitung that the company's first priority is paying down $22 billion in debt, but strong cash flow should take care of that fairly quickly. And then, Novartis' appetite for deals is likely to sharpen, Reuters reports.

"We could soon be in the position to go for acquisitions again, even if they are not as big as Alcon," Jimenez told the Swiss newspaper. The Zurich-based drugmaker bought the eye-care company Alcon in a two-phase deal that wrapped up earlier this year.

Before that, Novatis snapped up other assets in smaller deals, such as the $400 million buyout of antibiotics company Protez Pharmaceuticals and the $932 million deal for Speedel Holding, its blood pressure drug partner.

Jimenez also said Novartis is on track to meet its goal of boosting sales by double-digits this year. Its margin-improvement goals are also doable, he said, measured in constant currencies. Half-year results are due July 19.

- read the news from Reuters
- get more from Bloomberg

Read more about: Novartis, Pharma buyout, Joe Jimenez
back to top

3. Chinese docs trade up to jobs in pharma sales

By Tracy Staton

What's a low-paid Chinese doctor to do? Become a pharma rep. As Bloomberg reports, physicians in China are abandoning medical practice for jobs in drug sales, finding that they can better their $300-a-month doctors' salary by marketing drugs, rather than prescribing them. The human resources firm Aon predicts that as many as 14,000 Chinese doctors will join foreign drugmakers over the next 5 years.

Such is one unintended consequence of Big Pharma's Chinese gold rush. As drugmakers have laid off thousands of reps in the U.S. and Europe, they have been hiring big-time in emerging markets, especially China. The competition for drug reps in China is intense, too; turnover rates are high as major drugmakers such as Sanofi, Eli Lilly, Merck and Bayer recruit one another's salespeople.

Needless to say, doctors are highly in demand because of their specialized knowledge. "In most other countries, it's extremely rare to get fully trained doctors as medical representatives," Chris Lee, managing director of Bayer Healthcare China, told the news service.

Losing doctors to the drug business could exacerbate an existing shortage of physicians. China has only one doctor per every 7,000 people, and the government has been offering incentives such as free training to attract more people into primary care. Doctors willing to work in villages can win even more perks, such as relocation fees.

It's all part of China's effort to revamp its healthcare system, the very effort that has experts predicting big growth in the Chinese drug market for years to come. That growth, of course, has foreign drugmakers salivating--and jockeying for their share. As Bloomberg notes, Aon predicts that foreign pharma's Chinese offices will hire at least 35,000 sales staff by the end of 2014. That would more than double their sales force, which amounted to 33,000 at the end of 2010.

- read the Bloomberg story

Read more about: China, Pharma sales reps
back to top

4. Pfizer bids for $770M Lipitor extension in EU

By Tracy Staton

Pfizer ($PFE) is poised for a Lipitor reprieve in Europe. The company has asked for 6 months' of additional exclusivity in most EU countries under regulations designed to promote pediatric drug trials. The extension could be worth almost $800 million as it staves off generic competition until May 2012, the Financial Times reports.

Pfizer is in line for the 6-month extension because of studies in children with a genetic disorder that causes high cholesterol. The company plans to launch a chewable, grape-flavored version of Lipitor in November as a result of those trials. "Pfizer certainly pulled off a bit of a coup," Heart UK's Dermot Neely told the FT.

The development is sparking some debate over the European pediatric trials regulations, which were instituted in 2007. But officials and experts say that the pediatric program has resulted in research that wouldn't have been conducted otherwise. "The regulations have been a big advance in developing medicines for children, but throw up some issues which it may be time to revisit," Alasdair Breckenridge, chairman of the UK's Medicines and Healthcare Products Regulatory Agency, told the newspaper.

Although the cholesterol fighter is already facing copycat rivals in some European countries--Spain, Finland and Norway--it's still under patent elsewhere in the EU. Pfizer has won or is seeking 6-month extensions in at least 11 other markets, the FT says, including the U.K., France and Germany.

- read the FT story

Read more about: Europe, Pfizer, Lipitor
back to top

5. Bayer's Yasmin to face EU generics this year

By Tracy Staton

Bayer's birth-control franchise suffered a blow in Europe as patent regulators yanked protection on Yasmin. As the company's second-best-selling drug, Yasmin could now face generic competition later this year, Reuters notes.

The European Patent Office's ruling comes after an appeal from the Novartis generics unit Hexal, which had been fighting Bayer's patent on a procedure that reduces the size of particles containing Yasmin's active ingredient. That micronization patent would have been in force through 2020 thanks to officials' 2006 decision confirming the patent.

Now, Hexal is set to launch copies of Yasmin during the second half of this year, JP Morgan Cazenove analysts told investors after the ruling was announced. The European development comes after Yasmin lost patent protection in the U.S. last year. Sales in the states dropped last year to $1.6 billion.

The silver lining for Bayer, however, is that European pricing on Yasmin is much lower than in the U.S., giving cheaper generics a smaller cost advantage, analysts said. Plus, in most European markets, women pay out-of-pocket for contraceptives, meaning that insurers pushing for less-expensive copycat drugs might have less of an impact. "Although a negative surprise to the market, this event has a very modest impact to our valuation," UniCredit analyst Craig Maxwell told the news service.

- see the Reuters news

Read more about: Generics, Patent, Hexal, Yasmin
back to top

Also Noted

Spotlight On Obesity: A Pharma Matters Report

Download this insightful review from Thomson Reuters, which focuses on Obesity and looks at a relatively untapped market, in proportion to the scale of the potential market and the related diseases associated with obesity. Covered by this report is an in-depth critique of licensing, as companies strive to invest in the potentially profitable obesity drugs of the future. Click here to download the report.

TODAY'S SPOTLIGHT... Teva, Merck agree to 2017 date for Vytorin copies

Teva Pharmaceutical Industries has agreed that it won't sell generic versions of Merck's ($MRK) cholesterol drugs Vytorin and Zetia until 2017, settling patent disputes between the two companies. Merck still faces a patent fight with Mylan over Zetia and Vytorin, however. Report

@FiercePharma: Nine of 10 Big Pharmas cut sales reps in 2010. Report | Follow @FiercePharma

> The FDA has approved GlaxoSmithKline's Boostrix vaccine to prevent tetanus, diphtheria and whooping cough in people aged 65 and older. News

> Warner Chilcott said a U.S. federal court ordered a Boehringher Ingelheim unit not to launch a generic version of its inflammatory bowel treatment Asacol until Dec. 31. Story

> India's Orchid Chemicals & Pharmaceuticals said its API facility received a closure notice over disposal of solid waste, affecting its production of the antibiotic cephalosporin. Item

> Teva Pharmaceutical Industries faces two court hearings today. A U.S. court will consider the company's case against the developers of generic Copaxone, while a U.K. court will hear Pfizer's patent infringement case against Teva on Lipitor. Article

> Lonza, the world's biggest maker of drug ingredients, agreed to buy Arch Chemicals for $1.2 billion to create the global leader in the business of killing bacteria and fungi. Report

> Johnson & Johnson's Scios unit was charged by U.S. prosecutors with misbranding the heart drug Natrecor because the medicine's labeling allegedly lacked adequate directions for use. News

> Hikma Pharma said it purchased a significant minority interest in Hubei Haosun Pharmaceutical through the subscription of new equity for a cash consideration of $5 million. Item

> Dietary supplement manufacturer USANA Health Sciences Inc said it got approval from the FDA to make over-the-counter drugs. Article

> Belgian medical equipment and services company Arseus plans to buy a Brazilian peer for €51 million ($73 million) to secure the top spot in the world's largest pharmaceutical compound market. News

Biotech News

@FierceBiotech: Pfizer's potential offload of biz units could aid R&D prospects. Article | Follow @FierceBiotech

> Merrimack Pharma takes shot at $172.5M IPO with cancer contenders. Article

> Sanofi MS drug shines, biotech strategy advances. Story

> Amgen widens cancer reach in $1B-plus Micromet deal. Item

Biotech IT News

> Two computational biology standouts honored. Report

> IBM cloud aids fight against superbugs. Story

> Health informatics giant Optum changes CEOs. Article

> Sequencing giant BGI advances in bioinformatics game. Report

> BioTox buys CRO Bio-Quant, eyes software integration. Story

> Biomolecular computer shows promise in detecting disease. Article

Medical Device News

> FDA may change premarket notification requirements for radiology devices. Report

> SurgiQuest closes $19M round. Piece

> QIAGEN amends offer for Cellestis, provides update on Ipsogen. News

> BD gets partial win in patent case. Story

> Medtronic advises doctors of pump problem. Article

> Medtronic buys two surgical products companies. Report

And Finally... An international research team has discovered a strain of gonorrhea resistant to all currently available antibiotics. Report

Webinars

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Events

> BioImmersion: Biotech for the Non-Scientist - July 13-15, 2011 - Chicago, IL

Three-day class delivering an in-depth understanding of both fundamental and advanced science and technology concepts. Focusing on the healthcare industry, participants learn about biologics- what they are, how they are discovered, how they are developed and how they are used as therapies. Learn More.

> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR

> Skill-building and Summer Fun in Boston!

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: | 07.14.11 | Merck job cuts to accelerate; Expect more pharma M&A, less hiring

2011-07-17T22:31:00.001-03:00

-------- Original Message --------

Subject:	\| 07.14.11 \| Merck job cuts to accelerate; Expect more pharma M&A, less hiring
Date:	Thu, 14 Jul 2011 12:36:59 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

July 14, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsor:
INC Research
Sermo Surveys
eKnowledgeBase

Publisher's note:
Weekly Sermo Survey Partnership

Spotlight:
FDA taps Dartmouth ex-dean for new post

Also Noted:
Elan to shutter 104-employee PA facility; Eisai to market Orion products in China; Much more...

News From The Fierce Network:
1. GSK gets Boostrix approval for adults over 65
2. Reps discuss Scottish device, diagnostic biz
3. GSK CEO: West can compete in manufacturing

This week's sponsor is INC Research.

Publisher's Note

Weekly Sermo Survey Partnership

Notice the physician survey we ran in yesterday's FiercePharma just below this space? Readers can now expect the same exclusive insight into physician sentiments every Wednesday thanks to an innovative new partnership we've struck with Sermo.

Sermo is a community of 120,000 doctors spanning 68 specialties collaborating on cases and discussing drugs and devices online. That network can power significant insights, providing our readers with more premium-level content you've come to enjoy from Fierce.

Yesterday we learned what doctors think about the decline in the availability of pharmaceutical sales reps. Did they increase their use of digital tools to find information on drugs and devices? Do they replace a visit from a sales rep? What information would they prefer to see from those reps?

Readers are encouraged to check out this week's full analysis. I'm surprised to learn the percentage of doctors who claimed digital tools saved them time--it wasn't what I expected.

We'll be tweeting the surveys a few times a week using the #sermosurvey hashtag, and once FiercePharma's Facebook and LinkedIn communities launch later this summer, readers are welcome to share and discuss each week's findings there, too.

We strive to be the first place you turn for pharmaceutical industry news. Have any feedback on how Fierce continues serving your needs as a reader? Email me or find me on twitter. Thanks for being part of the Fierce community! - Arsalan Arif, Publisher

Webinars

Events

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Physicians' Perspective: Digital Tools and the Pharmaceutical Sales Representative

Sermo Study shows 78% of MDs Use Digital Tools to Gather Intelligence on Drugs/Devices

Are physicians turning to digital tools more to find information on drugs and devices? Find out what they had to say.

Sermo, the largest online physician network, announced a free report titled Physicians’ Perspective: Digital Tools and the Pharmaceutical Sales Representative. This report gathered feedback from physicians to understand their use of digital tools and how they effect sales representative meetings.

See the Complete Report

[Physicians: 97 respondents]

This week's sponsor is eKnowledgeBase.
	FREE two-week trial. Searchable online database providing access to verified company and drug competitive intelligence. Stay current on company, product, and pipeline performance/activity plus FDA actions, brand representation, and clinical initiatives. Click here.

Today's Top Stories

1. Merck job cuts set to accelerate

By Tracy Staton

Merck's ($MRK) long-planned job cuts are set to accelerate. The company announced its intent to shed some 15,000 jobs by 2012 last year, but thousands of those jobs have yet to go. Sources tell Pharmalot that Merck plans to amp up its layoff process soon, probably early next month.

Merck announced the cuts in the wake of its 2009 merger with Schering-Plough. The idea was to save some $3.5 billion by slashing the payroll by 10% and shuttering facilities. Such an enormous restructuring plan takes time, of course, and as of March, Merck still had about 8,000 jobs remaining to be cut, Pharmalot figures.

Now, the layoffs will speed up, the blog's sources said. And they may not end with the announced 15,000. Company insiders tell Pharmalot that officials may want to cut the workforce even more than they had planned. Merck execs are combing operations for more ways to save money, they say. The company itself declined comment.

Merck's layoffs, while quite substantial, are still fewer than Pfizer's announced job cuts in association with its Wyeth merger. Other Big Pharma firms have cut back by the thousands as well.

- read the Pharmalot post

Read more about: Merck, pharmaceutical layoffs
back to top

2. Expect more pharma M&A, less pharma hiring

By Tracy Staton

If you're a pharma M&A junkie, then the next couple of years should make you happy. Unfortunately, the news isn't as good for those seeking a job in the drug industry. That's the message from a new KPMG survey of 100 pharma executives, many of whom expect difficult times ahead.

Some 83% of top pharma officials say they expect their companies to either buy or be bought over the next two years. Cash-rich drugmakers will continue their quest to restock pipelines and fill revenue gaps created by new generic competition. In addition, they're looking to further their geographic expansion by investing in deals or organic expansion into more emerging markets.

But all that emphasis on deals and expansion is defensive. Pharma executives still expect the business to be tough over the next several years, with the most optimistic 30% seeing economic recovery by the end of 2012 and the least-optimistic 27% predicting recovery by the end of 2014. "The good news is companies have cash to invest in or acquire new medicine breakthroughs, or markets and customers to drive some growth," KPMG partner David Blumberg said in a statement. In other words, in this economy, expect to buy growth, not fuel it from within.

No wonder, then, that the hiring picture looks pretty bleak. Only 41% of the executives said they'd be adding to their payrolls in 2012. Even more frightening: Almost one-quarter expect hiring to "never...return to pre-recession levels."

- read the KPMG release
- get more from the Philadelphia Inquirer
- see the coverage from PharmaExec

3. Yervoy may help BMS survive Euro-squeeze

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=106&ms=MzU0NDQzMAS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTExNzIxMDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_J5hc7JrL0IxUH1jHZ0gSA" >Twitter | Facebook | LinkedIn

Bristol-Myers Squibb ($BMY) is joining the chorus of drugmakers bewailing Europe's troubles. Economic crisis means cash-strapped countries aren't paying their bills on time, putting a pinch on pharma payables, BMS Europe chief Ron Cooper told Dow Jones. Meanwhile, drug-price cuts and austerity-level spending exacerbate the pain.

The sovereign debt crisis has an immediate effect on payables, Cooper said. It's not just Greece that's in arrears with pharma. "Many of these countries are taking increasing amounts of time to actually pay," he told Dow Jones. But it's also a longer-term threat, because financial limitations can in turn limit countries' willingness to pay for new meds.

However, luckily for BMS, it has a promising new drug to help offset these roadblocks to European growth. Yervoy, the company's breakthrough treatment for advanced melanoma, got the final nod from European regulators yesterday. Given that it's the first new treatment in decades, and the first approved treatment to significantly extend patients' lives, even budget-minded governments are likely to dig deep into their pocketbooks to pay the (steep) cost.

Pricing for Yervoy in Europe will be roughly equal to U.S. pricing: €21,000, or $29,927, compared with $30,000 per infusion. But Cooper figures that because of the small number of eligible patients, the impact on healthcare budgets will be limited, Reuters reports. BMS counts some 8,000 people have advanced melanoma in France, Italy, Germany, Britain and Spain combined.

"Our hope for continued growth in Europe is based on driving more volume and adding new products," Cooper told the news service. "Luckily we have a strong pipeline and that gives us opportunities to grow volume, sell new products and hopefully overcome some of those significant price impacts."

- get the release from BMS
- see the Dow Jones interview
- read the Reuters article

Read more about: Bristol-Myers Squibb, Europe, Yervoy
back to top

4. French minister overhauls pharma regs

By Tracy Staton

The scandal surrounding Servier's Mediator drug in France has spawned a new approach to regulating pharma. Under pressure from an increasingly distrustful public, Health Minister Xavier Bertrand has proposed sweeping changes to France's regulatory framework, InPharm reports.

French regulators have been feeling the political heat from recent disclosures linking as many as 2,000 deaths with the now-withdrawn diabetes drug Mediator. The Servier drug was allowed to stay on the market in France after it had been withdrawn for safety reasons in other European markets. It was finally withdrawn there in November 2009. Some have blamed France-based Servier's close ties with doctors and regulators for Mediator's long stay on the market, InPharm notes.

The new regulations will require additional assessments of new drugs, mandate disclosures from industry and bar pharma funding of professional education. They'll also provide tighter controls on off-label prescribing. Mediator was often prescribed off-label in France for weight loss. Sales-rep visits to doctors would also be restricted. French lawmakers will begin considering the proposals this fall.

In the meantime, the ministry has begun reviewing 19,000 drugs currently approved in France. Bertrand predicts that many existing meds will be withdrawn because they can't demonstrate they're not inferior to other treatments.

- read the InPharm coverage

Read more about: drug safety, Mediator, Servier
back to top

5. As Advair sales erode, Benlysta gets EMA nod

By Tracy Staton

Has GlaxoSmithKline's ($GSK) Benlysta hit the market just in time? As the company celebrated the FDA nod for its new lupus drug--to be marketed with partner Human Genome Sciences--and then wrapped up European approval, sales of its Advair respiratory drug began to decline. As PharmaTimes reports, the asthma and COPD treatment saw sales fall 7% in June, and year-to-date revenues have dropped by 5%.

Analysts are lamenting the decline, and some see it as a harbinger of worse to come. Generic versions are beginning to crop up, and Goldman Sachs expects copycat Advair to be widely available in Europe within 9 months. In fact, Goldman says pressure on the Advair franchise will cause the stock to underperform.

But on the bright side, GSK execs continue to maintain that Advair generics won't replicate the company's inhaler device, meaning that they won't be fully substitutable, and that, in turn, will help slow down generic adoption. And Matrix's Navid Malik backs up that view, PharmaTimes notes.

What's more, there's Benlysta. It has nabbed final EMA approval after U.S. approval in March. That's one reason why Malik is upbeat about GSK's near-term prospects. He figures the drug should counteract lack of confidence in the company's ability to pull off the kind of growth it needs in the next few years--and he expects GSK to manage top-line growth by next year, just as other Big Pharmas are suffering most.

- read the release from GSK
- see the Dow Jones news
- get more from PharmaTimes

Also Noted

TODAY'S SPOTLIGHT... FDA taps Dartmouth ex-dean for new post

The FDA has named former Dartmouth Medical School dean Stephen Spielberg to the newly created position of deputy commissioner for medical products and tobacco as part of a management restructuring, according to an internal letter sent to agency employees. Report

@FiercePharma: Note to Pfizer: Bayer shopping for vet buys. Article | Follow @FiercePharma

> Elan is eliminating 104 jobs from a Pennsylvania facility that is part of the $960 million sale of its drug delivery unit to Alkermes deal. The facility is expected to be closed by September, the company tells Pharmalot. News

> Eisai has linked up with Orion to sell two of the Finnish drugmaker's breast cancer and Parkinson's disease treatments in China. Item

> Teva Pharmaceutical Industries completed its acquisition of Taiyo Pharmaceutical for $934 million in cash. Story

> Nigeria's second-largest drugmaker, May & Baker, plans to start exports to western and central Africa before the end of this year, CEO Nnamdi Okafor said. Article

> U.K. primary care trusts are not slashing the drugs budget as a cost-cutting move under the NHS' quality, innovation, productivity and prevention program, a leading official has told PharmaTimes. News

> Skin treatments supplier Sinclair IS Pharma said full year revenue raced ahead of expectations last year due to a strong performance in its fourth quarter and the contribution of its newly merged business. Report

Biotech News

@FierceBiotech: J&J's success with Hep C partners might hit a snag. Story | Follow @FierceBiotech

> Bristol-Myers grabs EU approval of key melanoma drug. Article

> DVS Sciences lands $14.5M round with Big Pharma support. Report

> Verastem snags $32M for drugs against cancer stem cells. Item

Manufacturing News

> Indian pharmas seek to protect their edge Report

> Corpedia, Second City bring comedy to compliance training. Item

> Hamburg appoints FDA deputies; Spielberg oversees drugs. Report

> GSK's Witty: West can compete in manufacturing. Story

> Pew track/trace call highlights congressional dallying. News

> Expert: Boost audit programs to keep up with outsourcing More

Vaccines News

> With Gates Foundation backing, Liquidia advances novel flu vaccine. Item

> Shingles vaccination levels fall short of expectations. Report

> Crucell and Scripps find antibody for universal flu vax. News

> The CIA, bin Laden and the future of vaccine programs. Story

> GSK gets Boostrix approval for adults over 65. Article

> Microneedles may be better for H1N1 delivery. More

And Finally... People who regularly drink tea or coffee may be less likely to be carriers of the "superbug" MRSA, according to a U.S. study. Report

Webinars

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Events

> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR

> Skill-building and Summer Fun in Boston!

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management

Explore Our Network

You may enjoy these publications from FierceMarkets:

Fwd: | 07.15.11 | U.K. workers dispute Novartis severance

2011-07-17T22:31:00.000-03:00

-------- Original Message --------

Subject:	\| 07.15.11 \| U.K. workers dispute Novartis severance
Date:	Fri, 15 Jul 2011 12:07:13 -0400 (EDT)
From:	FiercePharma <editors@fiercepharma.com>
Reply-To:	editors@fiercepharma.com
To:	nbrauchitsch@yahoo.com

If you are unable to see the message below, click here to view.

July 15, 2011

Subscribe | Website | Jobs | Mobile
Refer FiercePharma to a Colleague

This week's sponsors:
INC Research
eKnowledgeBase
An Expert Briefing: Biotechnology 101

Spotlight:
Should pharma refocus on customers, not shareholders?

Also Noted:
J&J unit wraps up Russian OTC buy; Cephalon shareholders OK Teva deal; Much more...

News From The Fierce Network:
1. Transcend Medical boosts Series B to $51M
2. Vical, Astellas ink $130M vax licensing deal
3. Zyngenia grows with MedImmune vets at helm

This week's sponsor is INC Research.

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Webinars

Events

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

This week's sponsor is eKnowledgeBase.
	FREE two-week trial. Searchable online database providing access to verified company and drug competitive intelligence. Stay current on company, product, and pipeline performance/activity plus FDA actions, brand representation, and clinical initiatives. Click here.

Today's Top Stories

1. U.K. workers dispute Novartis severance pay

By Tracy Staton

Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=81&ms=MzU0NjU4OQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTExNzYyNjEyS0&mt=1&rt=0" name="api_addthis_com_oexchange_XdtDBUzqKNTm8pnrY0yQ" >Twitter | Facebook | LinkedIn

Layoffs are not a happy business in the best of circumstances. But when workers think they're being treated unfairly, tempers can really run high. Take the job cuts at Novartis' ($NVS) facility in Horsham, England. The company announced in March that it would slice 550 positions from the plant's workforce. And as the cuts move ahead, employees are protesting.

As the West Sussex County Times reports, 150 workers at the Horsham facility are balking at their severance settlements. The workers have been offered two weeks' pay for each year served--which might have been fine, had they not heard that downsized employees at Novartis' Liverpool facility were offered twice that much. The difference, the workers claim, is that Liverpool's staff is unionized, while Horsham's is not.

In Liverpool, 190 workers face losing their jobs, but the UNITE union negotiated a four-weeks-per-year-of-service severance deal with the company. The Horsham workers filed a grievance to protest the difference, saying that the company had discriminated against non-union employees. After a three-month review process, the company determined that there was no discrimination, the Times reports.

The reported discrepancies have angered and disillusioned workers and the local community. In the past, Novartis has been praised as a good corporate citizen and an "exceptionally good employer." The company will continue to operate at Horsham, with a workforce of at least 330, The Argus reports.

For its part, the company issued a statement to the paper. "[A]ll redundant employees will be offered a severance package that will be enhanced from that required by statute." The company said it had considered "all counterproposals" made by employees, and that other assistance will be provided, including outplacement services and opportunities for alternate jobs elsewhere. The severance packages now await final approval, the company said.

- read the County Times story
- get more from The Argus

Read more about: Novartis, pharmaceutical layoffs
back to top

2. Medicis shares drop on death at CEO's house

By Tracy Staton

When do a CEO's personal problems become worrisome to investors? Well, it depends on the problem. In the case of Medicis Pharmaceutical chief Jonah Shacknai, the answer is, "Almost immediately." Two days after his 6-year-old son suffered critical injuries from a fall down a staircase at his Coronado, CA, house, Shacknai's live-in girlfriend was found bound, nude, and hanging from a balcony there. Within hours of the news, the company's stock plummeted.

Word is that Shacknai and his ex-wife were at the hospital with their injured son when the woman was found. Shacknai's brother Adam, who was staying in a guesthouse on the property, cut the woman down and called police, the Los Angeles Times reports. After initial evidence-gathering, the San Diego County Sheriff's Department and Coronado Police were saying they didn't know whether the death was murder or suicide. They have found no link between the boy's fall and the woman's death.

"We have not determined if this is criminal or if this is a death investigation," Capt. Tim Curran of the sheriff's department told the Wall Street Journal. "Whether it is a homicide or a suicide, it is one of the most bizarre and unusual cases we have ever seen."

Piper Jaffray analyst David Amsellem called the stock drop "just a little panic selling," Bloomberg reports. "There's no question that Jonah is very much the face of the company and very much a part of the overall vision and strategy," Ansellem said, but added that the company's day-to-day operations aren't likely to be affected by the Shacknai tragedies. Medicis has "very good bench strength," he said.

- see the WSJ coverage
- get more from Bloomberg
- read the LA Times article
- check out the Reuters news

3. U.K. reforms leave NICE in judge's chair

By Tracy Staton

Remember the reports that the U.K.'s cost-effectiveness watchdog would be shunted aside as the country adopts value-based pricing? Well, scratch that. As the government rethinks proposed National Health Service reforms, it's also reconsidering its overhaul of the drug-pricing chain of command.

Yes, the U.K. health system will be moving to value-based pricing--whatever that turns out to mean--by 2014. But the National Institute for Health and Clinical Excellence won't become an advisory body whose decisions about cost-effectiveness are only, well, advisory. NICE will keep its teeth, agency chief Andrew Dillon told Reuters. It will still have the authority to decide which treatments should be used by NHS.

So, how might NICE work in the value-based pricing era? The new scheme will aim to put higher prices on drugs that are most effective, most innovative and address unmet medical needs. NICE is likely to set up a series of cost-effectiveness brackets to help companies determine where new products are likely to fall, Reuters reports. "The government wants a system that is as predictable as possible...so that it will be very easy for companies to work out whether or not the NHS is likely to find their price acceptable," Dillon said (as quoted by the news service).

And if NICE doesn't accept a company's proposed price? All this has yet to be worked out, but Dillon took a stab at it. "[I]f the price is beyond the relevant threshold," he said, "then my assumption is that would trigger negotiations between the government and the pharmaceutical company."

- get the Reuters news
- see the InPharm coverage

ALSO: Novartis failed to win approval from the U.K.'s health-cost agency for its drug Lucentis in diabetics who suffer an eye condition. Report

Read more about: drug prices, NICE, United Kingdom
back to top

4. Judge says Boehringer rep eligible for OT pay

By Tracy Staton

Time to update your sales-rep overtime scorecard. A federal judge has ruled that a Boehringer Ingelheim rep is not exempt from overtime pay under the Fair Labor Standards Act, Pharmalot reports. It's just the latest decision in the ongoing legal battle between salespeople, who say they deserve OT, and drugmakers, who consider their reps "outside salespeople" who don't qualify.

In the Boehringer case, Judge Ursula Ungaro determined that plaintiff Graciela Palacios not only was not an outside salesperson, but that she did not fit the FSLA's administrative exemption, either. That exemption applies to management and professional types who are able to act on their own discretion and use independent judgment at work, as Pharmalot notes. Ungaro said the Boehringer rep's job did not fit that description.

The summary judgment comes after the U.S. Supreme Court passed on an opportunity to review appeals court decisions granting overtime to reps for Novartis and Schering-Plough. That choice essentially ratified the Second Circuit's ruling, which means that similar lawsuits in that Circuit--such as those pending against Pfizer, Abbott Laboratories and Bristol-Myers Squibb--are likely to go the same way.

But another circuit court--the Ninth--has ruled for GlaxoSmithKline in an OT dispute with reps. Amgen and Johnson & Johnson's Ortho-McNeil unit are on the no-overtime side of the ledger, too. How all the different suits in different jurisdictions will shake out remains to be seen. But some legal experts expect the Supreme Court to end up intervening at some point.

- see the Pharmalot post

5. Can generics biz cure a blockbuster hangover?

By Tracy Staton

Anyone who's been watching pharma knows that the number of big new drugs has been dropping. That's obviously a problem for Big Pharma. But it's going to become a problem for branded drugmakers' major nemesis: the generics industry. Makers of copycat meds like to knock off blockbusters because they stand to deliver more return on the up-front investment. As branded drugmakers increasingly turn out smaller, more specialized meds, there will be fewer big drugs to copy.

Much has been made of the fact that Big Pharma's patent losses over the next few years will be the generics business's gain. Drugs accounting for billions in sales are falling off patent, and copycat drugmakers will reap the benefits from that steady stream of big new products. It's like a baby boom; after the boom generation moves through, there's a bust. The difficulty branded drugmakers have had in getting new meds approved means that there will be fewer products for generics makers to copy as time goes on.

"What has happened is that the approval of new products over the last many years has not gone significantly beyond 25-30 per year. And not many of these products have become very large," Sun Pharmaceutical Chairman Dilip Shanghvi told MarketWatch. "All of this has created a challenge both for Big Pharma as well as the generic industry."

And what do leading generics companies plan to do to deal with that eventuality? The strategies will sound familiar. They're eyeing geographical expansion in emerging markets and preparing for possible consolidation through M&A. And they're also looking to build up businesses in brand-name specialty drugs. All strategies that Big Pharma is using right now to deal with its own blockbuster withdrawal.

In his interview with MarketWatch, Shanghvi talked about possible acquisitions in emerging markets, as well as organic growth in those countries, partly through a partnership with Merck. Brand-name specialty meds are in his sights, too. "[I]t's natural for us to also look at growing by becoming a specialty pharma company," he said. "Because then we can introduce our own products and use those for future growth."

- read the MarketWatch interview

Also Noted

TODAY'S SPOTLIGHT... Should pharma refocus on customers, not shareholders?

A management guru prescribes "radical" changes for Big Pharma--including abandoning DTC advertising. In his view, the industry can only leap ahead when its leaders unlearn traditional management thinking and focus their organizations on continuously delivering more value to customers sooner. Report

@FiercePharma: Expect more pharma M&A, less pharma hiring. Report | Follow @FiercePharma

> Johnson & Johnson's Cilag unit has completed its $245 million acquisition of some of the most popular OTC cough and cold medicines in Russia. Story

> Cephalon stockholders voted to approve Teva Pharmaceutical Industries' proposal to acquire Cephalon for $81.50 per share in cash, or a total enterprise value of approximately $6.8 billion. More

> President Obama's campaign committee moved a fund-raiser from the Pfizer world headquarters to another New York City location after the Boston Globe inquired about the propriety of a Big Pharma firm hosting a benefit for the administration regulating it. Piece

> Goldman Sachs analysts reiterated their "buy" rating on Shire stock, helping to send the U.K. company's shares up to an all-time high. Article

> Despite a net loss, Cubist Pharmaceuticals beat second-quarter expectations with a 5% increase in net sales, to $176.8 million. Release

> EMD Serono said interim president James Hoyes has been permanently appointed to that post. Story

> Global production of seasonal flu vaccine is expected to double to 1.7 billion doses by 2015, with 11 new manufacturers coming onstream in developing countries, the World Health Organization said. News

> President Barack Obama will soon send a free trade pact with South Korea to Congress for approval despite Republican threats to vote against it because of a retraining program for workers displaced by trade. Article

Biotech News

@FierceBiotech: Dendreon, cancer drug developers top slate of buyout candidates. Article | Follow @FierceBiotech

> Roche gearing up to seek approvals of breast cancer treatment. News

> Vical, Astellas ink $130M vaccine licensing deal. Report

And Finally... Internet searches are making information easy to forget, as more people rely on computers as a type of "external memory," a study found. Item

Webinars

> An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist

Events

> Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR

> Skill-building and Summer Fun in Boston!

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA

> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Marketplace

> Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years

Jobs

> Regional BD Director

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

Contact Us

Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson.

Advertise

Advertising/Lead-Generation: Ryan Willumson. Request a media kit.

Email Management