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Top 10 Pharma Layoffs of 2010

Thu, 17 Feb 2011 16:42:00 +0000

10. Bristol-Myers Squibb
Layoffs: 840

After cutting out 7000 employees last year, BMS only just made this year's cut with its September layoffs. The company continues to prepare for the Plavix patent cliff, as generic counterparts take over a larger portion of the market. BMS was posting higher-than-expected profits when the layoffs occurred. But although the company's other drugs, including the antipsychotic Abilify continue to do well, Plavix's US$6.5 billion is hard to replace. As Edward Jones analyst Linda Bannister says, "With the patent cliff all these companies are facing, they need to reduce costs as quickly as possible to navigate what is going to be a very challenging couple of years for the industry."

9. Novartis
Layoffs: 1400

After much concern that Novartis would release Roche-esque layoffs, the company ended the year announcing 1400 cuts from the sales department, all of which would be effective starting January 1 2010. The layoffs come primarily from the company's General Medicines sales force, as it prepares for the effects of numerous patent expirations. Instead, the company will focus its sales efforts on specialty drugs, according to a statement. Novartis is still assessing its efficiency in sales, marketing and manufacturing, which could lead to more extensive job cuts in the coming years.

8. Takeda
Layoffs: 1400

As Takeda prepares for diabetes drug Actos' patent expiration, it announced 1400 jobs cut within the US. "The business environment for the pharmaceutical industry is changing dramatically," the company says in a statement, "with the pharmaceutical industry as a whole facing barriers to technological innovation that have halted progress in breakthrough novel drugs, stricter approval processes for new drugs in advanced nations, and radical upheaval in healthcare systems." The cuts came primarily from Takeda's US headquarters in Deerfield, IL and the Takeda Global Research and Development Center.

7. Sanofi-Aventis
Layoffs: 2500

The cuts included shuttering its Great Valley, PA facility and shaving 400 from its sales force, but the largest cuts came in October. The company cut out 25 percent of its Pharmaceutical Operations division, more sales reps and eliminated 300 more from its Bridgewater, NJ facility. "Given the serious challenges facing our organisation and the healthcare industry, it is important to act decisively now so that our organisation has greater stability moving forward and that our resources are allocated to our strategic growth priorities," says Gregory Irace, CEO of Sanofi-Aventis US/Canada Pharmaceutical Operations. Recently, sources told Pharmalot that Sanofi sales reps would find out their fate via conference calls: one for those retained and one for those laid off. According to the company, the latest layoffs will keep the sales force at a manageable size until 2013.

6. Abbott Labs
Layoffs: 3000

After purchasing Solvay Pharmaceuticals, Abbott found the need to eliminate 3000 jobs, the largest layoff in the company's history, with the majority of those hitting its European operations. "The restructuring will streamline our operations and improve efficiencies across the pharma business as we said we'd look to do at the time we announced the acquisition," Abbott spokeswoman Melissa Brotz said to the Wall Street Journal. As part of the restructuring, Abbott closed Solvay's Marietta, GA offices and cut staff from Hannover, Germany and Weesp, Netherlands. But the layoffs aren't over; PharmaTimes expects more layoffs over the next two years as the company continues the Solvay integration.

5. Bayer
Layoffs: 4500

Bayer's layoffs came with the company's new strategy to focus on emerging markets. While 4,500 will lose their jobs, the company plans to create another 2500, particularly in Asia. Emerging markets has been a determining factor in many companies' layoffs as they search for new lines of revenue in an increasingly difficult economy. For Bayer, it's the price of doing business. "To finance the expansion of our growth activities," CEO Marijn Dekkers said in the statement, "we therefore need to redirect resources, improve efficiencies and cut costs."

4. Roche
Layoffs: 4800

Roche came back in force, laying off 4800 workers in one fell swoop this November. Those cuts will take place over the next two years, along with another 800 transfers in-company and 700 to third parties. According to the company's release, 2650 of those cuts will come from sales and marketing. The company cited taspoglutide's poor results as one of the factors in the layoffs. "This is a comprehensive, focused initiative to reinforce Roche's long-term innovation capability in the face of increased price pressures and a more challenging market environment. We will continue to drive our highly promising product pipeline to help seriously ill patients and contribute to more efficient healthcare systems," Roche CEO Severin Schwan (photo) said in a statement. The cuts should save Roche US$2.7 billion through 2012, and another US$2.4 billion after 2012.

3. GlaxoSmithKline
Layoffs: 5201

CEO Andrew Witty spent the year finding cost-saving options for the company, including laying off workers in Europe and the US, including 700 from the sales and marketing division. GSK believes the future is in emerging markets, particularly in Asia and South America, and its transferring much of its muster into those areas with numerous deals. But beyond layoffs, Witty looked at other failing strategies, including spending GBP£3 billion in nine years on research that found no new products.

2. Pfizer
Layoffs: 8480

Pfizer has dropped to number two with over 10,000 fewer job cuts announced this year. It announced the total 8480 layoffs in relatively smaller batches: 1080 in two January announcements, and 7400 in separate May releases. After merging with Wyeth, the company found redundancies as it accumulated Wyeth's three dozen sites into the fold with its previous 40. "We have a complex network of manufacturing plants," said President of Manufacturing Nat Ricciardi, "with excess capacity that is not good for costs." And Pfizer found places to cut in New Jersey, Pennsylvania, New York, Puerto Rico, Ireland, the UK and Germany. The process isn't nearly completed yet; the layoffs will take effect over the next five years.

1. AstraZeneca
Layoffs: 8550

AstraZeneca started off the new year with 8000 job cuts announced on top of the 15,000 from 2009. The company wasn't shy; it reduced staff in virtually every area of the company, from chain operation to R&D, sales, marketing and admin. And a month later, it cut another 550, shutting its doors in Wilmington, DE as well as UK and Swedish facilities. AstraZeneca has been cost cutting since 2007, originally planning on eliminating 7400 positions by 2013. Three years later and the total is up to 23,550.

CureFAKtor Pharmaceuticals Receives Orphan Drug Designation

Wed, 19 Jan 2011 10:27:00 +0000

CureFAKtor Pharmaceuticals, LLC, a privately-held biopharmaceutical company focused on the research and development of Focal Adhesion Kinase (FAK) inhibitors for cancer, today announced that its lead compound, CFAK-C4 , which is in development for the treatment of pancreatic cancer, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S.

Orphan Drug Designation provides for a number of potential incentives related to CFAK-C4, including a seven-year period of marketing exclusivity, reduced regulatory fees, certain tax credits, and additional regulatory support for research and development initiatives.

"Receiving Orphan Drug Designation by the FDA is an important milestone for CureFAKtor, as well as for pancreatic cancer patients who have the lowest survival rate of any cancer and limited treatment options," said H. Shep Wild, President and Chief Executive Officer of CureFAKtor Pharmaceuticals. "CFAK-C4 is the first clinical candidate derived from our broad FAK technology platform and we look forward to progressing CFAK-C4 into human clinical trials."

CureFAKtor Pharmaceuticals is planning a Phase I clinical study of CFAK-C4 in combination with gemcitabine chemotherapy, the current standard of care for pancreatic cancer, in 2012.

CureFAKtor Pharmaceuticals was formed in 2008 based on fundamental discoveries of distinguished cancer researcher Dr. William Cance, Chair, Surgical Oncology, Surgeon-in-Chief Roswell Park Cancer Institute. The Company, to date, has been funded primarily by grants from the National Institutes of Health (NIH). CureFAKtor's proprietary FAK technology platform may represent a significant breakthrough in the treatment of most solid tumors in that its unique mechanism of action disrupts the signaling of FAK in tumors by targeting specific protein to protein bindings. Since FAK is over-expressed in virtually all solid tumors, the technology has broad applicability in oncology.

More than 40 compounds have been identified that target FAK signaling sites. CFAK-C4, discovered by Dr. Elena Kurenova, Ph.D. Associate Professor, Roswell Park Cancer Institute, Senior Scientist and Co-Founder of CureFAKtor, is the lead product candidate in CureFAKtor's pipeline. In pre-clinical studies, CFAK-C4 demonstrated efficacy in a number of cancers including pancreatic, breast, advanced melanoma and neuroblastoma. The Company's second product candidate, CFAK-Y15, discovered by Dr. Vita Golubovskaya, Ph.D. Associate Professor, Roswell Park Cancer Institute, Senior Scientist and Co-Founder of CureFAKtor, is being investigated for the treatment of breast, pancreatic, neuroblastoma and colon cancer.

CureFAKtor has attracted a renowned Board of Directors which includes David Keiser, Former President and Co-Founder of Alexion Pharmaceuticals, Inc. and Dr. Daniel Kleiner, Surgeon and Clinical Instructor at the University of Virginia. Scientific Advisory Board members include: Dr. Murray Brennan, Former Chair of Surgery at Memorial Sloan-Kettering Cancer Center; Dr. Edison Tak-Bun Liu, Executive Director of Human Genome Institute of Singapore; and Dr. Alex Adjei, Senior Vice President of Clinical Research and Chair of the Department of Medicine at Roswell Park Cancer Institute.

"Focal Adhesion Kinase protein binding inhibitors represent a promising area of research as FAK is expressed at extremely high levels in solid cancer tumors to serve as a survival mechanism by signaling tumor growth, invasion and metastasis. Dr. William Cance's groundbreaking work has shown that FAK protects tumors from chemotherapy, radiation and the body's natural defenses," said Dr. H. Shelton Earp III, M.D., Professor and Director of Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill School of Medicine. "While still early stage, I look forward to further research into the effect CFAK-C4 may have on solid tumors."

About Focal Adhesion Kinase (FAK)

Focal adhesion Kinase (FAK) is substantially over-expressed in many solid tumors. FAK operates by placing itself at the contact points between tumor cells and the extra cellular matrix that surrounds them. Studies by CureFAKtor and others found that in this role, FAK is an important facilitator for signals that cause tumor cells to survive, grow, and produce new blood vessels to sustain growth and travel to distant places within the body where they may establish new tumor sites. It also cocoons the tumor cells to protect them from the body's natural signaling mechanisms that would cause deviant tumor cells to be eliminated. In a similar fashion, FAK protects tumors from chemotherapeutic drugs and radiation, allowing the tumor cells to resist these therapies.
About CureFAKtor Pharmaceuticals

CureFAKtor Pharmaceuticals is a biopharmaceutical company focused on the research and development of Focal Adhesion Kinase therapies to prevent or treat cancer. CureFAKtor's investigational and combination therapy products target pancreatic, breast, colon, melanoma, lung and brain oncology disorders. CureFAKtor research is conducted at the Roswell Park Cancer Institute. Additional information about the company may be found at www.curefaktor.com.

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Pharma to See Big Growth in East in 2011

Wed, 05 Jan 2011 14:23:00 +0000

According to investment international, 2011 will be a successful year for the pharmaceutical industry due to a rise in emerging markets, which is estimated to grow by 70 percent by 2015.

China plans to invest £125 billion supporting health reform according to Peter Kirkman, fund manager of the JPM Global Consumer Trends Fund. He also confirmed that governments in Russia and Brazil have made similar commitments.

"Growth for the healthcare sector is shifting eastwards. Not only is there a growing population to look after but there is also a lot of catching up to do in terms of understanding the relationship between healthcare spending and productivity."

Kirkman points out that the rise in Eastern pharma is due to unprecedented amount of state healthcare insurance expansion and health infrastructure building. The result means Eastern markets have now overtaken those in the West. Pharmaceutical consumption growth also outstrips per-capita GDP growth. Chinese GDP has grown around 10 percent in recent years whilst pharmaceutical spend growth has been 25 to 30 percent per year.

The emergence of Eastern markets positively impacts its Western counterparts. Sanofi-Aventis, the major diabetes manufacturer has seen 30 perfect of its custom coming from emerging markets as Diabetes becomes a growing problem there. In Russia, for example, 45 million people have Dyslipidemia which is caused by too much cholesterol in blood.

"Investors can tap into the emerging market healthcare boom by investing in Western pharmaceutical brands that are active in emerging markets. Stocks like GlaxoSmithKline, for example, have high EM exposure with 16% of their total sales for the first nine months of 2010 coming from the region," said Kirkman

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Neovacs: Crohn's Disease Immunotherapy Trial Success

Mon, 13 Dec 2010 08:50:00 +0000

Neovacs, a biotechnology company focused on active immunotherapy for autoimmune and inflammatory diseases and cancer, today announced the final results of its Phase I/II clinical trial of TNF-Kinoid which showed:

- the drug candidate's excellent safety profile in all subjects.
- an immune response to the drug as intended, and
- a high clinical response rate, with clinical remission (absence of symptoms) in almost half the patients.

The TNF-K-001 Phase I/IIa clinical trial was performed in 21 patients suffering from moderate to severe Crohn's disease (defined as a Crohn's Disease Activity Index (CDAI) of between 220(1) and 400). Each patient received three administrations of one of three dose levels of TNF-Kinoid (60 mcg, 180 mcg or 360 mcg) on days zero, seven and 28, with four patients also receiving a maintenance dose at month six.

The study's primary objective was to assess TNF-Kinoid's safety and its ability to induce an immune response to tumor necrosis factor (TNF). The final results presented today confirm the drug candidate's excellent safety profile; no treatment-related serious adverse events, unusual infections or premature study withdrawals were recorded. Reactions to administration of the Kinoid (whether local or systemic) were mild, transient and limited to a few patients.

In terms of immune response, in 17 of the 21 treated patients, TNF-Kinoid induced the production of anti-TNF antibodies. Of the three patients receiving the lowest dose (60 mcg), only one mounted an immune response to TNF. In both the 180 and 360 mcg dose levels, eight of the nine patients in each group (89 percent) produced anti-TNF antibodies.

In terms of clinical response (at study week 12 and after three administrations of the drug), 76 percent of the patients showed a significant clinical improvement (defined as a 70-point drop in the CDAI) and 43 percent of these patients were in clinical remission (i.e. the absence of symptoms, as evidenced by a CDAI at or below 150).

"These results are highly encouraging and promising. They constitute a key milestone for Neovacs and mark the start of our validation of this unique therapeutic approach based on active anti-cytokine immunization", commented Neovacs CEO Guy-Charles Fanneau de La Horie. "The study enabled us to gather extensive data on TNF-Kinoid's safety and immunogenicity. Our ongoing clinical development program is designed to confirm these results in the months ahead, as announced at the time of our IPO: we are in the process of initiating a double-blind, placebo-controlled Phase II study in Crohn's disease", he added.

"Despite progress in treating Crohn's Disease, both patients and doctors want to see new treatments," noted Professor Antoine Cortot, Head of the Gastroenterology Department at Lille Hospital- France. "These first results with the TNF-Kinoid in 21 Crohn's patients are promising; they now need to be confirmed in a larger number of patients."

About Crohn's disease

Crohn's is a chronic and progressive inflammatory disease of the gastro-intestinal tract associated with an autoimmune pathology. Crohn's manifests itself via a range of debilitating symptoms, including severe diarrhea, abdominal pain and cramping, intestinal strictures and fistulae and malnutrition. It is most frequently diagnosed in young adulthood. In the vast majority of cases, patients receive long-term treatment which focuses on suppression of the immune response, although surgery is also part of the therapeutic arsenal. The central role of TNF in the pathology of this disease has been confirmed by the clinical efficacy of monoclonal antibodies targeting TNF. Nonetheless, current medical options are limited, and in particular there is a need for drugs that can durably induce and maintain remission, a development eagerly awaited by both physicians and patients. According to Datamonitor, Crohn's Disease affects nearly one million people in the seven largest pharmaceutical markets.

About Neovacs

Neovacs is a biotechnology company focused on an active immunotherapy technology platform (Kinoids^TM) with applications in autoimmune diseases and other chronic conditions. Neovacs' current portfolio consists of 3 drug candidates: TNF-Kinoid, IFNα-Kinoid and VEGF-Kinoid. The company's lead immunotherapy program (TNF-Kinoid) targets TNF-mediated chronic inflammatory diseases. For TNF-Kinoid, a Phase I/II clinical trial in Crohn's disease and a Phase II trial in rheumatoid arthritis (RA) are ongoing. The latter clinical study is also the focus of collaboration with the French diagnostics company BMD, with the goal of developing theranostic tools for personalized care in RA. Patient recruitment is ongoing in a Phase I/II trial of Neovacs' second product candidate (IFNα -Kinoid, an immunotherapy targeting interferon alpha) in the treatment of lupus. Neovacs' R&D has generated a broad patent estate.

For more information, visit the Neovacs website at www.neovacs.com

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Aspirin Reduces Cancer Risk by 21%

Tue, 07 Dec 2010 16:48:00 +0000

British researchers revealed in an article published in The Lancet that a daily dose in the range of 75mg to 500mg of Aspirin reduced the risk of cancer by 21 percent. In most cases, the effects increased with time, with better results persisting for up to 20 years.

The findings of the study involved 25,570 participants who had been on aspirin therapy for at least four years. In all cases the trials compared aspirin to a placebo.
As well as cancer, the study revealed that death by other means was reduced by 10 percent by those patients on 75mg of aspirin per day.

The effect of taking a daily dose of aspirin reduced cancer risk by 21 percent on average, although differing cancers faired differently. Esophageal/throat cancer risk was reduced by 60 percent, bowel cancer by 40 percent, lung cancer by 30 percent and prostate cancer by 10 percent.

The study was carried out by Study leader, Professor Peter Rothwell at Oxford University, who believes that his team's findings will have a major impact on public health policy.

The study from Prof Rothwell represents strong evidence that aspirin can prevent the development of cancer, especially in the gastrointestinal tract, It is of more than academic interest: it should stimulate a re-evaluation of the role of aspirin with wider use of the drug. At the same time, we are acutely aware that aspirin is not without risks. In particular, it can cause internal ulcer bleeding and patients on aspirin should take a protective anti-ulcer drug such as omeprazole," said Professor Chris Hawkey, President of the British Society of Gastroenterology.

"But aspirin is not the only measure needed to reduce the risks of cancer. Lifestyle measures such as remaining slim, not smoking or drinking to excess and eating a healthy diet all have an important part to play. People should not ignore warning symptoms like rectal bleeding especially if associated with tummy pain, change in bowel habit or weight loss."

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Ian Read to Replace Jeffrey Kindler as Pfizer CEO

Mon, 06 Dec 2010 13:49:00 +0000

Pfizer, the world's largest pharmaceutical company has announced that CEO Jeffrey Kindler has retired, paving the way for global biopharmaceutical operations, Ian Read, as his successor.

Jeffrey Kindler cited his retirement was due to the "extremely demanding" role and the effects it had on him personally.

"The combination of meeting the requirements of our many stakeholders around the world and the 24/7 nature of my responsibilities has made this period extremely demanding on me personally," said Kindler in a prepared statement released late Sunday. "I am excited at the opportunity to recharge my batteries, spend some rare time with my family, and prepare for the next challenge in my career."

Ian Read will inherit a company who has reduced its workforce by 6000 employees, and its shares fall by 35 percent to $16.73, as of Dec. 3 in New York Stock Exchange trading. Pfizer will also lose patent protection in the U.S. next year for Lipitor, which had $11.4 billion in sales last year. While the drugmaker moved to make up for the loss by paying $68 billion last year to acquire Wyeth, adding the Enbrel arthritis treatment and Prevnar pneumonia vaccine, it also has had four setbacks this year in developing its research pipeline.

Pfizer also said yesterday it was creating a $75 million fund and new compliance panel to settle shareholders' lawsuits that charge top company officials failed to stop illegal marketing of drugs. Pfizer last year paid $2.3 billion to settle US claims it marketed treatments for unapproved purposes.

"It is in the best interests of the company and our shareholders to reach an agreement that allows us to put this matter behind us on favorable terms," Pfizer's Kerins said in an e-mail to Bloomberg. "Subject to court approval, the agreement includes measures that reinforce and build on existing provisions of our compliance program and that formalize actions the directors and officers undertook in connection with matters at issue."

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Survey: FDA and Industry Relationship Complicated

Wed, 01 Dec 2010 14:04:00 +0000

PricewaterhouseCoopers (PwC) most recent survey ‘Improving America's Health V- A survey of the working relationship between the life sciences industry and FDA' outlines a complicated and strained relationship between the life sciences industry and its chief regulator, the US Food and Drug Administration (FDA) according to reports.

Specifically, the survey highlights that the complications occur because of rising public demand for safety and the need for faster development of medical products. It also outlined that while life sciences companies feel communication with FDA has improved since the FDA Modernization Act came into force in 1997, growing expectations are fuelling mounting frustration with the regulatory review process.

Breakdown

Within the survey, 38 percent of life sciences companies said they feel that the overall working relationship with FDA has improved over the past two years. 80 percent said that FDA is providing better guidance about its expectations. 68 percent of companies said they are incorporating this feedback into product development.

64 percent of companies that met with the FDA before submitting raw material said that it improved the quality of their applications. 87 percent said it expedited their applications, but industry did not always take advantage of the meetings and only about half (53 percent) said FDA consistently encouraged these meetings.

60 percent of companies expressed frustration that FDA had changed its position during a review, and 40 percent said some products were denied because of FDA's inadequate review resources.

The FDA were also accused of not keeping up with rapidly advancing technology, while only eight percent of drug and device makers think FDA is doing enough to advance personalized medicine.

51 percent of consumers think FDA does a good job, but a significant portion (over a third) said they had lost confidence in the agency in the last two years following high profile safety concerns and product recalls. And 97 percent of consumers said company reputation is an important factor in deciding whether to use a medical product, with 49 percent saying it is "very important."

"Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost healthcare that demonstrates enhanced economic and clinical value."

"Hope lies in accelerating scientific and technological advancement as we learn more about genetic differences and individual responses to treatments. But the promise of faster product development has yet to be realized and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations," said Michael Mentesana, PwC's US Pharmaceutical and Life Sciences Research and Development Advisory Services Leader.

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Johnson & Johnson Recalls Benadryl Allergy Tablets

Wed, 24 Nov 2010 14:11:00 +0000

Johnson & Johnson has recalled four million packages of Children's Benadryl allergy tablets and 800,000 bottles of junior-strength Motrin caplets. The news is a setback for the world's largest healthcare manufacturer, as it is still reeling from a number of recent high-profile recalls.

Although J&J didn't confirm particulars about the recall, it did state that the products were safe and were still useable, citing that there were "insufficiencies in the development of the manufacturing process."

"There is no indication that the recalled products do not meet quality standards," the company said in a notice posted last week on the individual websites of the drugs, "and this recall is not being undertaken on the basis of adverse effects."

The recalls were made at in Fort Washington, after a review of manufacturing procedures at McNeil Consumer Healthcare, a subsidiary based there. The review was launched back in April after a FDA inspection uncovered several deficiencies. McNeil also ordered the recall of 146 million bottles of children's medication made at the facility, including liquid Tylenol, Motrin, and Benadryl. The plant remains closed.

Specifically, children's Benadryl allergy Fastmelt tablets, in cherry and grape flavours, and junior-strength Motrin caplets, 24 count were recalled. The medicines have a wide circulation, including distribution in the United States, Canada, Puerto Rico, Belize, Barbados, St. Martin, and St. Thomas.

The recall adds further pressure on J&J, who recalled thousands of vials of anti-cancer drug Velcade following reports of white particles floating in the medicine. The recalls were carried initiated in January and June in Europe, Japan, Malaysia and the US. Europe was the most affected, with 195,000 vials requested back.

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Resverlogix Announces Top ASSERT Results

Wed, 17 Nov 2010 16:19:00 +0000

Resverlogix Corp. (Resverlogix) (TSX:RVX) announces its top line results of the ASSERT Phase 2 clinical trial which will be highlighted at the prestigious American Heart Association Scientific Sessions 2010 Late Breaking Clinical Trial session, by principal investigator Dr. Stephen Nicholls of the Cleveland Clinic. The top line ASSERT trial data was designed to answer questions about how to best proceed with future trial designs for Resverlogix' lead oral small molecule drug RVX-208.

The ASSERT trial data demonstrated that the three key biomarkers in the reverse cholesterol transport (RCT) process showed dose dependant and consistent improvement. The trial showed dose dependent increases in ApoA-l, statistically significant increases in HDL cholesterol including alpha1 particles or functional HDL, and highly statistically significant increases in large HDL particles. RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus reducing and/or preventing atherosclerosis.

In the high dose, ApoA-I achieved a 5.6 percent increase with a statistical value of p=0.06. The overall ApoA-I biomarker showed a dose trending statistical significance of p=0.035. Data presented also showed that the ApoA-I and other HDL particles continued to be increasing at the end of the 12 week study. Both the 8.3 percent HDL cholesterol increase and the 21.1 percent large particle HDL increase were highly statistically significant, p<0.01 and p<0.001 respectively. These pronounced HDL related increases via ApoA-I production are important as they take place later in the RCT chain of events and strongly indicate plaque regression potential.

"These are very encouraging early findings which suggest the drug (RVX-208) is working in the established patient population that it was designed for, being patients with advanced coronary disease," said Dr. Stephen Nicholls, MBBS, PhD, Medical Director of Intravascular Ultrasound and Angiography Core Laboratories at Cleveland Clinic and Clinical Director of the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention.

Donald McCaffrey, President and Chief Executive Officer of Resverlogix commented, "The study largely replicates findings previously seen in our earlier 28 day trial, more importantly these findings are now being shown in patients with coronary artery disease on optimal standard of care. The positive changes seen in this trial represent advancement over the current best standard of care available in the USA. We are now well positioned to advance RVX-208 to the next clinical trial having witnessed the substantial and consistent elevation of HDL by ApoA-I production; which strongly indicates that RVX-208 should remove unwanted plaque from the arterial wall which is our main goal."

Resverlogix Senior Vice President of Medical Affairs Dr. Jan Johansson stated, "In patients who received the newer class of statins and had baseline HDL below 45mg/dL, an important high-risk subpopulation, the middle dose of 200 mg saw the most pronounced increases of 12 percent in ApoA-I (p<0.002), 21 percent in HDL cholesterol (p<0.015) and 32 percent in large particle HDL (p<0.018). We are delighted by these results and now have a much better understanding of what doses to use and what patient population to target moving forward in our ASSURE Phase 2b trial."

An additional presentation at the AHA meeting was given by Dr. Norman Wong, Chief Scientific Officer of Resverlogix, containing new data detailing the effects of RVX-208 in vivo. The presentation was titled "RVX-208: An Orally Administrated Small Molecule Reduces Atherosclerosis in ApoE Null Mouse and Raises ApoA-I/HDL in Humans". In the ApoE null mice model of atherosclerosis, the oral administration of RVX-208 reduced aortic plaques in two separate models. The presented model showed plaque reductions of up to 41percent

About Resverlogix Corp.

Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs. The NexVas^TM PR program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-l. These vital therapies address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Diabetes, Alzheimer's disease, Peripheral Artery Disease and other vascular disorders. Resverlogix Corp.'s common shares trade on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com

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Warfarin Shown to be Less Effective Than Xarelto in Study

Wed, 17 Nov 2010 09:45:00 +0000

Johnson & Johnson's Warfarin, the gold standard anti-clotting drug has been shown to be less effective than Bayer's Xarelto in a new trial combating atrial fibrillation.

The trial, ROCKET AF included more than 14,000 individuals - the largest ever such trial - and showed a 21 percent reduction in the risk of stroke. The trial also highlighted a difference outlined in complicated bleeding , with Xarelto significantly better in intercranial haemorrhage, critical organ bleed and bleeding-related death.

According to Savant Ahmed, a London-based analyst for the Royal Bank of Scotland, Xarelto should take at least a third of the blood-thinning market for Warfarin replacements, following the approval of another rival drug called Pradaxa. Pradaxa (dabigatran etexilate) was approved in Europe in 2008 for use as a clotbuster following orthopaedic surgery.

"If you look at the data, Pradaxa and Xarelto are just a lot better than warfarin," Leslie Iltgen, a Frankfurt-based analyst at Bankhaus Lampe KG, told Bloomberg in a telephone interview.

Xarelto and Pradaxa also allow patients to avoid repeat laboratory tests; warfarin needs repeated tests to ensure proper levels. Xarelto also offers superior efficacy and simplified dosing - one tablet a day.

"We have a drug you can take once a day, without monitoring, that is at least as good as warfarin and carries no additional risk," said Robert Califf, the study co-chairman and vice chancellor for clinical research at Duke University Medical Center in Durham, North Carolina. "The findings as we dive into the details of the data look better and better."

Bayer gained 2.09 euros, or 3.9 percent, to 56.13 euros at the 5:30 p.m. close of trading in Frankfurt, the biggest advance in more than three months. J&J climbed 47 cents, or less than 1 percent, to $64.14 at 4 p.m. in New York Stock Exchange composite trading.

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The Future of Pharma Production is Asia?

Thu, 11 Nov 2010 13:05:00 +0000

Reshaping the pharmaceutical industry's quality standards is currently the top priority for the Chinese government. Earlier announcements by its Ministry of Health to issue new tougher Good Manufacturing Processes (GMP) standards for medical products comes at the right time as current regulations do not meet international standards which result in poor performance by Chinese companies in the international market.

In order to respond to these GMP changes, Chinese manufacturers however are in urgent need to upgrade their facilities and technologies, as failure to comply will result in closure. The NGP Asia committee has called an emergency meeting to combat the current situation.

Asia has become a more attractive place to conduct clinical trials (CT) but as it grows so do the challenges. For pharmaceutical companies, Contract Research Organizations (CROs) or Central laboratories (CL) the biggest challenge is keeping trials on track, on time and on budget; all three are key to global competitiveness. In the last 10 years Asia has been targeted by pharmaceutical companies from across the globe who wish to take advantage of the region's ethnic diversity and huge population to test their medicines at an affordable price. Asia has now moved to a position where they can challenge to become the number one contender for CT, the US.

The NGP Asia Committee, who will be meeting at the NGP Asia summit believes the revitalized competitiveness of Asia is down to two main factors: "Firstly, conducting trials in the west is increasingly expensive. Secondly, there is scepticism over trial involvement by western consumers and difficulties in finding the right kind of patients."

The committee will be made of representatives from A-Bio - Steven Lee, CEO, ME & Greater China, AstraZeneca - Uma Nandan Misra, VP Operations, Celltrion - Daniel Slone, VP Manufacturing and Eisai Inc. - Sanjit Singh Lamba, President.

With the US seeing $110 billion in global sales exposed to generic competition for the top 50 pharmaceutical companies through to 2014, branded pharma must look to emerging markets, biologics and continued cost-saving initiatives to drive growth according to Analysts.

The top 50 pharma companies are forecast to experience a US sales decline of 1.3 percent year-on-year, with sales falling from US$228 billion to US$214 billion. However, major markets outside the US are forecast to grow by 2.4 percent year-on-year, offsetting the US decline. Emerging markets are forecast to experience double-digit growth rates over the next few years, with an average year-on-year growth rate of 12 percent. It is this growth rate that will see Asia fill the gap.

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Pfizer Profits Decline 70% from Same Quarter Last Year

Wed, 03 Nov 2010 11:44:00 +0000

Despite a third-quarter revenue increase of 39 percent because to the acquisition of Wyeth, the deal has meant the New York-based Pfizer recorded a drop of 70 percent profit due to substantial charges during the transaction.

Monetarily, the 70 percent drop equates to $866 million, or 11 cents per share, down from $2.88 billion, or 43 cents per share, a year earlier.

Utilizing new Wyeth products such as biologic drug Enbrel for rheumatoid arthritis, Prevnar vaccine against ear and blood infections, and Premarin hormone replacement pills increased Pfizer's biggest division, the sale of prescription drugs, which increased to $13.95 billion, a healthy leap of 31 percent.

Pfizer saw a reduction in sales of Lipitor, the world's top-selling drug - an 11 percent drop at $2.53 billion - due to the availability of generic variants on the market; namely the cholesterol drug Zocor.

Lipitor also loses patent protection in November 2011, and its sales are expected to fall sharply after that. Pfizer did confirm that it doesn't foresee a decline in sales, with estimated 2012 sales of $65.2 billion to $67.7 billion. As a failsafe, , the company announced it would acquire King Pharmaceuticals, a maker of pain medications, for $3.6 billion, possibly to offset the losses posed by Lipitor.

Pfizer's other top sellers included Enbrel, at $799 million; Prevnar and a successor vaccine that prevents more strains of pneumococcal disease, at $914 million; and Lyrica, up 7 percent at $757 million.

Those drugs seeing a decline included Viagra, Celebrex and Norvasc.

Pfizer's veterinary medicines saw an increase of 27 percent ($860 million). Capsugel, remained stagnant at $176 million. According to the Associated Press, Pfizer is considering selling that unit.

Pfizer raised its 2010 earnings forecast to $2.17 to $2.22 a share from $2.10 to $2.20, likely to reduce costs by up to $5 billion by the end of 2012.

Operations increased 37 percent, or $3.9 billion, from Wyeth products.

From January to September, over half of Pfizer's revenue was drawn from abroad, accounting for 57 percent; 43 percent of sales came from the US.

Despite the 70 percent decline in comparison to the same quarter last year, Pfizer Chief Executive Jeffrey Kindler said in a statement: "I am particularly pleased with the speed of the integration, the cost synergies achieved to date as well as our solid financial performance this quarter and year to date in this difficult economic environment. This combination clearly creates value for our shareholders."

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Dr. Francis Collins at American Society of Human Genetics

Thu, 21 Oct 2010 16:11:00 +0100

The American Society of Human Genetics (ASHG) will be hosting a special symposium titled, "Looking Toward a Healthier Future: Perspectives from the NIH" featuring NIH Director Dr. Francis S. Collins as the keynote speaker at the ASHG 60th Annual Meeting on Saturday, Nov. 6, 2010, from 12:00-1:00 p.m., at the Walter E. Washington Convention Center in Washington, D.C.

Dr. Collins' keynote presentation on "Exceptional Research Opportunities in Human Genetics in 2010" will address issues surrounding current priorities and support of bioscience and research policy for the nation. His presentation will also provide insight into future directions of research at NIH, and give an overview of some of the research areas funded by NIH.

Immediately following his keynote presentation, Dr. Collins will host a special press Q&A session from 1:15-1:45 p.m. in the ASHG Press Briefing Room (Room #101) located on the ground level of the Walter E. Washington Convention Center. This Q&A session will give press attendees the opportunity to ask questions and engage in an open discussion with the current NIH Director on relevant issues and topics of interest.

Some of the key research issues and topics that Dr. Collins may address in his keynote talk and the press Q&A session include:
• The future of stem cell research
• NIH Genetic Testing Registry (GTR) (and outcomes from the NIH GTR public stakeholder forum that will be held Tues., Nov. 2 at the ASHG 2010 Meeting)
• Personalized medicine and the translation and applications of genomic research in health care practice
• Current and future research funding priorities of the NIH
• Major policy issues that the science community should focus on

WHO: The following speakers will be featured in the ASHG 2010 Special Symposium:

• Introduction: Charles Lee, PhD (2010 ASHG Program Committee Chair)
Director, Molecular Genetic Research Unit & Associate Professor of Pathology, Harvard Medical School; Clinical Cytogeneticist, Brigham and Women's Hospital

• Keynote: "Exceptional Research Opportunities in Human Genetics in 2010": Francis S. Collins, MD, PhD, Director, National Institutes of Health (NIH)

WHEN: Saturday, November 6, 2010:

• 12:00-1:00 p.m. EDT Special Symposium: "Looking Toward a Healthier Future: Perspectives from the NIH" featuring keynote speaker: NIH Director Dr. Francis Collins

(Exhibit Hall C, Lower Level, D.C. Convention Center)

• 1:15-1:45 p.m. EDT Press Q&A Session with Dr. Francis Collins

(ASHG Press Office, Room 102B, D.C. Convention Center)

WHERE: Walter E. Washington Convention Center*
801 Mount Vernon Place, NW, Washington, D.C. 20001
(*See meeting rooms listed in section above)

WHY: Issues related to federal funding of scientific research endeavors are currently a hot topic of debate in our nation, and the implementation and translation of knowledge learned from federally funded research will play an important role in shaping the future of clinical practice in the U.S. health care system.

Since the ASHG 2010 Annual Meeting will be held in Washington, D.C. - the seat of policy and legislative power for the United States, and the seat of the competitive grants process at the National Institutes of Health - this year's featured keynote speaker will be NIH Director Dr. Francis Collins who will discuss important issues surrounding current research priorities and support of bioscience and research policy for the nation in his presentation titled, "Exceptional Research Opportunities in Human Genetics in 2010."

PRESS REGISTRATION FOR ASHG 2010 MEETING

If you wish to register to attend the ASHG 2010 Annual Meeting as a member of the press, please complete the online press pre-registration form at the following link by the deadline on October 28, 2010: http://www.ashg.org/2010meeting/pages/press_register.shtml. For all other media inquiries, contact Kristen Long, ASHG Communications Manager, via e-mail at klong@ashg.org, or call 240-281-2386.

GSK Commits to Delivering Advances in Rare Diseases

Wed, 20 Oct 2010 15:11:00 +0100

GlaxoSmithKline (GSK) outlined further details on Monday on its strategic focus and development priorities of the company's unit dedicated to rare diseases, which was launched in February 2010.

The European pharma giant announced its new alliance with Fondazione Telethon and Fondazione San Raffaele, which come at the same time as Marc Dunoyer, Global Head of GSK's Rare Diseases, outlined his ambitions for the unit and its potential to deliver significant benefits to underserved patient groups worldwide.

"GSK has a well established history of successfully researching and developing orphan drugs to treat rare diseases," affirmed Dunoyer. "For companies like GSK to continue to make significant progress in developing new treatments to address rare diseases it requires unique skills, commitment and most importantly a deep understanding of the conditions. For example, Atraince/ Arraon, for a difficult to treat form of leukaemia that affects only a few hundred patients worldwide each year, was the result of the dedication of one scientist, Gertrude Elion, whose personal insights and dedication led us to understanding the potential of this molecule and how it could be used to help a small group of patients who were in urgent need of another treatment option."

With between 6000 and 8000 rare diseases within its sights of possibility, Dunoyer recognizes that the unit's efforts will need to be focused. "We will target those diseases where we realistically believe we can make a significant contribution; ideally we will be creating new medicines, but importantly by adding to the weight of scientific knowledge into rare diseases to the benefit of all working in this area.."

"Selecting the diseases to target won't be easy and we will need to make difficult choices; we have adopted a systematic approach, which we believe will be critical to helping us make the right decision. Our aim is to have a list of around 200 priority diseases that the unit will target - this list will change over time as our scientific knowledge and understanding changes."

But it's not just about choosing the right disease; for GSK's rare disease unit, and indeed Dunoyer, it comes down to finding the right balance between disease prioritization, fuelling the R&D engine and finally turning molecules into medicines.

"To select the right molecules requires a strong R&D engine to continuously generate a large candidate pool," continued Dunoyer. "This is where I believe GSK has a unique offering. The R&D pipeline for GSK rare Diseases will be filled from within the unit, but also from across the entire GSK organization. Every scientist, whatever therapy area they are working, has been tasked with considering how a molecule or platform technology being developed could be applied to treat one of the thousands of rare diseases."

"Critically, I believe one of the most important capabilities of GSK, which is so vitally important in an area where there is a small number of patients spread worldwide, is our global reach," concluded Dunoyer. "We believe we not only have the ability to discover and develop the medicines, but also the successfully deliver them to those patients who really need them. Never have I been more committed or excited about our potential to truly make a difference."

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Novartis Continues Commitment Towards Leprosy Elimination

Fri, 15 Oct 2010 08:50:00 +0100

At a ceremony at the World Health Organization's (WHO) headquarters in Geneva, Joseph Jimenez, CEO of Novartis, and Dr. Margaret Chan, Director-General of the WHO, signed a Memorandum of Understanding (MoU) to ensure continued efforts toward the ultimate goal of a leprosy-free world.

Continuing in the same vain, the MoU sees Novartis provides free multi-drug therapy (MDT) medicines to every country in need of its services, having donated the equivalent of US$26 million in MDT, which will treat an estimated 1.1 million leprosy patients over the next five years and stretching into 2016. Going one step further, the Basel-based pharma giant will also provide up to US$2.5 million over the same period to cover the costs of handling the donation and logistics incurred by the WHO.

"The collaboration between Novartis and the WHO has been highly productive in eliminating leprosy as a public health problem. A key feature of this success has been the deep commitment of both parties," said Chan at the signing ceremony.

Since 1985, over 14 million people have been cured of leprosy thanks to MDT, significantly shrinking worldwide prevalence by roughly 95 percent. In 2009, less than 250,000 new cases were reported from more than 140 countries worldwide. However, despite the success, leprosy control remains at a critical crossroads - with knowledge of the disease slowly declining and a general awareness becoming less common. In order to counteract the trend, a continued effort to secure early detection and availability of free treatments are essential.

"Over the past 10 years, we have worked with the WHO to provide free treatment to leprosy patients globally," asserted Jimenez. "We have made tremendous progress, but the battle has not yet been completely won. We are committed to ensuring that patients receive the medications they need and we intend to contribute to this program until the final elimination of this debilitating disease."

Indeed, Novartis' commitment towards ridding the world of preventable diseases such as leprosy has also seen them set up the Novartis Foundation for Sustainable Development (NFSD), which plans and supports projects designed to strengthen and secure essential healthcare provision for the poor in developing countries. With help from its publications and events, the NFSD provokes dialogue on development policy between public and private-sector institutions, whilst importantly defining the nature and limits of corporate responsibility.

Consisting of three drugs: rifampicin, clofazimine and dapsone, MDT has helped bring leprosy levels a step closer to that dream ‘zero point'. Two of the drugs, rifampicin and clofazimine, were developed in the research laboratories of Novartis back in the 1980s. Multidrug Therapy has made it possible to cure patients through interrupting the transmission of leprosy between both organisms and communities, in turn preventing the crippling disabilities inherent with the disease. With MDT in place, even patients with the most extreme forms of the disease show visible clinical improvements within weeks of starting treatment.

The new MoU, effective from January 2011 through to December 2015, follows two previous and successful MoUs signed in 2000 and 2005 respectively.

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Key Patent Granted for Stem Cell Therapy

Wed, 13 Oct 2010 11:38:00 +0100

A new regenerative medicine technology, being developed by biopharmaceutical company Amorcyte, received the first U.S. patent in the industry to fully enable practical development of stem cell therapies for treating heart damage following a heart attack.

This is the first patent ever issued addressing the cell therapy, its delivery mechanism and methods for achieving potency and stability. It arises out of the finding that it is not sufficient to only give cells. It is necessary that the cells move and must be biologically active.

Amorcyte now holds both composition of matter and methods claims for any chemotactic (active cell that migrates via biological signal) hematopoietic (blood) stem cell therapeutic product used in treating or repairing a vascular injury following an acute myocardial infarction (AMI).

Claims of this patent titled "Compositions and Methods of Vascular Injury Repair" also include the catheter methods of delivering cells for stem cell therapies, as well as Amorcyte's proprietary formulation that maintains the potency of CD34+ stem cells having CXCR-4+ signaling receptors and their ability to migrate quickly after delivery to the vascular injury site of oxygen-deprived tissue in the heart.

Amorcyte's lead product, AMR-001, is in development for the prevention of major adverse cardiac events following AMI. AMR-001 uses the patients' own enriched bone marrow stem cells as treatment for cardiovascular disease. The process infuses CD34+/CXCR-4+ stem cells into the heart a week or so after a heart attack, where they migrate and linger helping to restore damaged tissue. The CD34+ stem cells are enriched using Amorcyte's proprietary technology to assure their potency, purity, sterility and product shelf-life. This enriched bone marrow stem cell therapy is affordable, easy to administer, less toxic and easily manufactured.

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Sanofi-aventis turns hostile in attempts to acquire Genzyme

Mon, 04 Oct 2010 15:11:00 +0100

In the changing face of pharmaceuticals, acquisitions and mergers are usually pretty straightforward affairs - that is, of course, unless you're stood in the shoes of Sanofi-aventis right now. After its several unsuccessful attempts to engage Genzyme, a US-based biotech firm, in discussions for a takeover, the French multinational has decided to cut the prolonged battle and turn hostile by launching an unsolicited €13.5 billion bid aimed at Genzyme's majority-owning shareholders.

Sanofi announced the €50.4-a-share bid one month after Genzyme turned down an approach at the same price. The French company said it had been left with no choice by Genzyme's board and directors, who believe that sanofi's bid significantly undervalues the firm and describes the initial approach as "opportunistic". However, the share price represents a 38 percent premium over Genzyme's unaffected share price of €36.43 on July 1, 2010. The offer further represents a premium of almost 31 percent over the one-month historical average shift price through July 22 - the day prior to speculation that Sanofi had indeed made an approach to acquire Genzyme.

Based on analyst consensus estimates, the offer represents a multiple of 36 times Genzyme's 2010 earnings per share and 20 times 2011 earnings per share. "A combination with Genzyme represents a compelling opportunity for both companies and our respective shareholders and is consistent with our sustainable growth strategy," said Christopher Viehbacher, CEO of sanofi-aventis.

"Sanofi-aventis shares Genzyme's commitment to improving the lives of patients, and our global reach and resources can help the company better navigate the issues it faces today. The all-cash offer provides immediate and certain value for Genzyme shareholders at a substantial premium that recognises the company's upside potential, while sanofi-aventis shareholders would benefit from the accretion and the attractive growth prospects of this combination."

Viehbacher concluded that: "Now is the right time for Genzyme to consider a transaction that maximises value for its shareholders. Sanofi-aventis believes strongly in this acquisition and its strategic and financial benefits. We remain focused on entering into constructive discussions with Genzyme in order to complete this transaction."

For the US-based bio-pharma firm, who leads the industry with its products addressing rare diseases, kidney disease, cancer, and transplant and immune diseases, sanofi's global reach and significant resources would allow Genzyme to accelerate investment in new treatments, enhance penetration in existing markets and expand further into emerging markets. However, for Genzeyme's CEO and Chairman, Henri Termeer, the positive doesn't seem to outweigh the negative - a sentiment Viehbacher highlighted in a letter reiterating the non-binding offer sent to Termeer.
In it, Viehbacher explained that: "Your continued refusal to enter into constructive discussions will serve only to further delay the ability of your shareholders to receive the substantial value represented by our all-cash offer. We therefore are prepared to consider all alternatives to complete this transaction. Our team and advisors are ready to meet with you and your team immediately to discuss our proposal and to move things forward expeditiously." For sanofi-aventis it seems like the days of playing the waiting game are over; for Genzyme, its time to decide: work against its shareholders and reap the consequences, or, as Viehbacher states in his letter, "consider a potential transaction that maximises value for Genzyme's shareholders."

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Pharma Answers at NGP US Drug Discovery Summit

Fri, 01 Oct 2010 14:33:00 +0100

With access, cost and quality concerns plaguing pharmaceutical delivery systems both in the US as well as globally, the Next Generation Pharmaceutical Drug Discovery committee has been formed to confront, assess and deliver new strategies to secure the future of the industry.

Meeting in Miami, Florida, the committee will discuss the state-of-play for personalized medicine, R&D challenges, translational medicine, imaging techniques and novel biomarkers - all connected by the pulse of the sector: the call for open innovation.

With significant uncertainty characterized by higher R&D costs, depleted pipelines and financial restrictions, the pharmaceutical industry can no longer function on its old model of closed innovation and completely protected intellectual property (IP). Gone are the glory days of blockbuster drugs on a conveyor-belt of success. With a rapidly approaching patent expiry cliff on the horizon, the pharmaceutical industry is at a crossroads with a tough decision to make: break with tradition and work on a new and unchartered business model or risk stagnant pipelines and the potential decline of the industry.

Indeed, the BRIC emerging markets are already making their stamp on the industry with their comparably lower costs, phenomenal population bases and vastly unmet medical needs - all of which combine to produce an exciting opportunity for ‘big pharma'. However in order to do that, success needs to continue to consolidate itself in developed markets if funding is to be able to siphon itself across. Open and reverse innovation is not just pivotal for companies on their home turf, but for the global community at large.

Through the sharing of risk, cost and IP through R&D strategic alliances including pharma, biotech, academic drug discovery centers and CROs, the developed markets can begin to look towards faster and more efficient models of R&D and delivery systems, knowledge sharing to promote quicker ROI and a far larger and comprehensive knowledge base that has never been possible, until now.

The Next Generation Pharmaceutical Drug Discovery committee will meet to mark out a path through the current global economic and industry pressures to pave the way for truly open innovation. With Daniel Ruppar, Director of Research for North American Healthcare at Frost & Sullivan, moderating the committee panelled by Maurico Futran, VP of Process R&D for Bristol Myers Squibb, and Garry Neil, CVP of Science and Technology at Johnson and Johnson amongst other key players, the committee is already firing on all cylinders to promote the key resources required to deliver a fully integrated and collaborative approach to next generation drug discovery and development.

With further attendees including John Orloff, SVP and CMO for Novartis, William Chin, Executive Dean for Research at Harvard Medical School, Jim Keirns, VP at Astellas Pharmaceuticals and Allan Shatzman, VP at GlaxoSmithKline, the Next Generation Pharmaceutical Drug Discovery committee is set to answer one question: Could open innovation models that have proved successful in other sectors be fruitfully adopted by the pharmaceutical industry and lead it into a new era of drug discovery?

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The universal voice of diabetes calls for new treatment

Thu, 23 Sep 2010 16:17:00 +0100

An in-depth, global survey has unveiled shocking statistics that point to over one in three diabetes patients skipping or failing to take their insulin as prescribed, stating that they have done so on average three times in the past month.

In addition, 77 percent of physicians estimated that in reality, the number of times people could miss their insulin could be as high as six doses in the past three months, according to the Global Attitudes of Patients and Physicians in Insulin Therapy (GAPPTM) survey, released today by Novo Nordisk.

Conducted in eight countries along almost 3000 respondents, the global survey also showed that 88 percent of physicians report that there are a significant portion of patients still not reaching anywhere near their blood glucose targets, with four in 10 diabetes sufferers saying they struggle to effectively control their blood sugar. Worryingly, the survey prior to this highlighted that globally, less than half of the diabetes population consistently reach an optimal level of health and quality of life.

Professor Luigi Meneghini, Associate Director at the Diabetes Research Institute at the University of Miami Miller School of Medicine, said: "The GAPPTM survey was designed to uncover the challenges patients and physicians are facing in obtaining effective outcomes in insulin therapy and it appears that busy lifestyles and difficulty in adhering to prescribed regimens are key contributing factors to poor glycaemic control. These results are consistent across countries and it is encouraging to see that physicians understand and empathize with the issues people with diabetes face."

For a large part, the non-compliance of prescriptions came down, rather simply as you would expect, to the modern-day change in lives as a work/home balance becomes tougher to juggle and forgetfulness often sets in. More than half of physicians agree that their patients do, indeed, find it incredibly hard to comply with their regimens, particularly managing the number of injections and strict time constraints involved. These findings were further backed by a previous report that identified that one in five patients - 19.4 percent with type 1 and 16.2 percent with type 2 diabetes - completely complied with all aspects of their prescribed regimens.

Another key factor that the survey found could contribute to poor glycaemic control is a substantial fear of hypoglycaemia. Sixty-seven percent of patients taking insulin are concerned about experiencing a hypoglycaemic event in the future, and physicians share their concern, with 74 percent stating that they would treat closer to recommended targets if it weren't for fear of major hypoglycaemic events.

Finally, the survey capped off its findings by detailing that nine out of 10 patients wished there was an insulin that could be dosed less than once a day, effectively managing blood sugar, with 67 percent of them feeling that diabetes has controlled their life since starting insulin. A further third of physicians claimed they were dissatisfied with current regimens' ability to fit into patients' dynamic lifestyles.

For the survey's funders, Novo Nordisk, this information should prove invaluable in targeting next generation diabetes treatments and innovative, progressive uses of insulin regimens. Considering the panel of diabetes experts used within the survey spanned every continent and every culture, there is no getting around the fact that these findings are the universal voice of diabetes sufferers - and should be listened to accordingly.

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Vit B could delay onset of Alzheimer�s

Mon, 13 Sep 2010 15:06:00 +0100

The results of a UK-based study last week has revealed that high doses of B vitamins could aid in delaying the onset of Alzheimer's disease in elderly patients displaying warning signs of the life-changing disease.

Published in the journal Public Library of Science One, the study looked at 168 elderly people experiencing levels of mental decline known as mild cognitive impairment. With half of the volunteers being given a daily tablet containing levels of the B vitamins foliate, B6 and B12 well above the recommended daily amount - and the other half being given an inescapable placebo - after a drawn-out two years, the rate at which their brains shrunk was measured and analysed.

The results speak for themselves, with the team from the Oxford Project to Investigate Memory and Ageing (Optima), finding on average that those taking the vitamin B supplements had their brain shrinkage slowed by 30 percent. Indeed, in more exceptional cases, Optima recorded a slowing down of more than 50 percent, making their brain atrophy no worse than those without cognitive impairment. Prior studies have showed that the average brain shrinks at a rate of 0.5 percent a year after the age of 60, with Alzheimer's patients rapidly overtaking that figure at 2.5 percent.

The vitamin B specifics in question - folic acid, vitamin B6 and vitamin B12 - all control levels of homocysteine in the blood; the higher the levels, the faster the brain shrinks and the onset of Alzheimer's begins. The study's author, Professor David Smith, told the BBC that the results were far more significant than he expected.

"These vitamins are doing something to the brain structure," he confirmed. "They're protecting it and that's very important because we need to protect the brain to prevent Alzheimer's." Smith hopes that further research into the findings could actually work out a way to prevent the development of the disease in patients with mild cognitive impairment.

However, despite the results, experts are warning people not to take the findings into their own hands. Chris Kennard, Chair of the Medical Research Council's Neurosciences and Mental Health Board, said: "We must be cautious when recommending supplements like vitamin B as there are separate health risks if taken in too high doses. Further research is required before we can recommend the supplement as a treatment for neurodegenerative diseases, such as Alzheimer's."

With this in mind, the UK's Food Standards Agency has set out guidelines to ensure that boundaries are adhered to, highlighting the fact that taking in excess of 200 milligrams of vitamin B6 a day could lead to a loss of feeling in the arms and legs, and ingesting more than 1milligram of folic acid a day could mask signs of vitamin B12 deficiency.

Fortunately, inhibiting further ingestion of the supplements in question can reverse the symptoms with no extensive harm. Regardless, for the world of Alzheimer's understanding and treatment, it seems as though things may have just stepped up a notch.

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