Pharmalive - Pharmalot

A Hundred Jobs Here, A Hundred Jobs There: More Pharma Layoffs

esilverman — Wed, 10 Apr 2013 15:30:00 +0000

As the pharmaceutical industry continues to contract, keeping track of the number of people thrown overboard is a challenging exercise, especially as the largest drugmakers eliminate jobs by the thousands in successive waves. Consequently, it can be easy to overlook other jobs cuts that do not land so prominently on the radar screen.

Nonetheless, in recent days, a few cutbacks have gotten under way. Mylan (MYL), for instance, is laying off nearly 120 people from its specialty offices in Basking Ridge, New Jersey, as part of a reorganization that will consolidate the specialty operation near its Pittsburgh headquarters. The cuts were disclosed in a state filing. A spokeswoman says some employees may relocate. The generic drugmaker is also closing a specialty plant in Napa, California, later this year, where nearly 270 jobs will be lost.

Meanwhile, Alkermes (ALKS) plans to slash up to 130 jobs from a plant in Ireland (read more here) and, last week, Bristol-Myers Squibb (BMY) disclosed some 300 people will be let go as part of a plan to close the San Diego headquarters occupied by Amylin Pharmaceuticals, which was acquired last year. Another blip on the radar was the news that Unigene Laboratories (UGNE) let go about 20 people as it struggles to survive.

Of course, there are always cuts in the pharmaceutical industry and this only encompasses a very few of the latest. But still more are expected. There is industry speculation, for instance, that Merck will undergo more job cuts. In any event, more than 3,100 industry job cuts in the US were tallied so far this year by Challenger Gray & Christmas, the recruiting and consulting firm.

Conversely, there is also consistent hiring as drugmakers shift goals and emphasize new priorities. And often, these additions are made in dribs and drabs and, therefore, often do not generate the sort...Read more

Another State Smacks Down Biosimilar Legislation

esilverman — Wed, 10 Apr 2013 14:35:43 +0000

Yet another state has rejected legislation that would make it more difficult to allow substitutions of biosimilars. This time, Maryland has declined to endorse the concept, which was advocated by some of the largest biotechs to thwart rivals from having easy entre to their lucrative markets (here is the Maryland legislation).

As we have reported previously, over the past few months, legislators in several states have been introducing bills that would allow interchangeable biosimilar substitution, but only if more cumbersome conditions are met by prescribing physicians and pharmacies (back story). The debate is about interchangeability.

Along with the Alliance for Safe Biologic Medicines, Amgen (AMGN) and Genentech, for instance, want clear lines drawn for substitution, such as giving physicians authority to specify “do not substitute” and that such an option should override any policy from payers or state law that would have substitution be the standard or default practice (read more here).

But the effort, not surprisingly, is meeting with considerable pushback from others, notably generic drugmakers. Ralph Neas, who heads the Generic Pharmaceutical Association, argues the bills would hurt state budgets and, in any event, are premature because the FDA has not yet issued guidelines for developing biosimilars.

For those keeping score, three other states - Arizona, Mississippi and Washington - have rejected such bills, and Arkansas sent a bill to a study committee. So far, North Dakota is the only state to pass this sort of biosimilar legislation. Virginia and Utah passed similar bills, but these contain sunset clauses,...Read more

Waiter, There's Cardboard In My Sample: FDA Warns Pfizer Over Manufacturing Gaffes

esilverman — Wed, 10 Apr 2013 13:52:43 +0000

In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of batches of a diluting agent for its Torisel kidney cancer drug and claiming false positives were caused by interference from cardboard packaging. Yes, cardboard. The drugmaker, however, failed to offer any "credible explanation" as to how cardboard may have made its way into the samples.

The other snafu was a failure to file field reports after learning of bacterial contamination. Specifically, the Catania, Italy, plant reported on April 17, 2012, that endotoxin results had been found on January 4, 2012, but the FDA did not receive a report until August 9, 2012. Meanwhile, a batch of the Torisel diluting agent had been shipped on January 5, 2012, to a packaging facility, which then shipped vials of the batch to the US on April 3, 2012.

This is a problem, of course, because the batch sent to the US was contaminated. And, the FDA notes in its March 27 warning letter, that field reports are supposed to be filed to the appropriate agency office within three working days after learning of problems with distributed drug products. Pfizer was not even close – four months elapsed before a report was filed and another four months went by until the FDA actually received the report (HERE IS THE WARNING LETTER).

As is the case in such situations, the FDA warned Pfizer that if the problems are not resolved, shipments of products made at its Wyeth Lederle plant in Catania may be blocked. Mistakes, as you know, happen all the time, but these are sorts of gaffes that the largest drugmakers are supposed to know how to avoid.

The failure to come to grips with basic manufacturing procedures can be a signal to the FDA to look more closely at other facilities in the...Read more

Pharmalot... Pharmalittle.. Good Morning

esilverman — Wed, 10 Apr 2013 13:14:31 +0000

Hello, everyone, and how are you today? We continue to cope with myriad technology changes, which we are led to believe will be resolved very soon. Just the same, we are forging ahead and invite you to join us for a much-needed cup of stimulation, or three. Sigh. Meanwhile, we have the ever trusty line up of tidbits for you to peruse. And as always, we have a busy day planned. So time to get cracking. Hope you have a grand day and, once again, we want to thank you for your patience and support. It is very much appreciated...

Glaxo Licenses Tykberg In China (Pharma Times)

Lilly Settles Wrongful Death Lawsuit Over Cymbalta (Indy Star)

Indian Vaccine Regulator Meets WHO Standards (Economic Times)

Dr. Reddy's To Open R&D Center In New Jersey (The Hindu)

Novartis Moving 120 Alcon Jobs To Massachusetts (Fort Worth Star-Telegram)

Unigene Struggles To Stay Afloat (The Street)

EDITOR'S NOTE: Please check this post for additional stories during the day

FDA Acknowledges: We Could Have Done More To Pursue Compounders

esilverman — Tue, 09 Apr 2013 15:58:53 +0000

For the past several months, the FDA has been widely criticized by Congress and others for not doing more to crack down on the New England Compounding Center, the now-bankrupt pharmacy tied to a nationwide outbreak of fungal meningitis that has led to 53 deaths (see this). Since the scandal broke, the FDA has argued various court rulings limited its authority, although critics maintain the agency has, in fact, been able to pursue violators, notably compounders that effectively mass produce medicines without individual patient prescriptions and ship out of state. Since early January, the FDA has responded to the pressure by inspecting 44 compounders (read here) and issued 31 reports (look here) detailing a host of violations, and follow-up actions are expected. Clearly, the agency is devoting more resources to a problem that has caused one of the worst public health crises in decades, and agency officials acknowledge that more could have been done sooner to thwart the NECCs around the country. We spoke with Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, and Howard Sklamberg, who heads CDER's Office of Compliance, about the issues...

Pharmalot: What are you finding so far at the (44) pharmacies you’ve been inspecting?

Sklamberg – Those are in a couple of categories. A majority, about 30, are inspections we did that are based on a risk model. One of the issues with compounding is because firms don’t have to register with us we don’t know right now the universe of firms out there and what they produce. We have fragmentary information about firms, based on past interactions with firms, based...Read more

More People Are Cutting Back On Medicine To Save Money

esilverman — Tue, 09 Apr 2013 15:01:24 +0000

File this under 'what a surprise.' In the aftermath of the recession, a growing number of adults have been searching for different ways to lower their spending on prescription drugs. In particular, those between the ages of 18 and 64 were twice as likely to not have taken medication as prescribed to save money compared with adults aged 65 and over - 12.6 percent compared with 5.8 percent - according to findings from the 2011 National Health Interview Survey, which were released this morning by the US Centers for Disease Control and Prevention.

This was not the only tactic for saving money, though, in a year when some $45 billion was spent on prescription drugs. In fact, the most popular approach for all adults was to ask a doctor to prescribe a lower-cost drug; roughly 20 percent of everyone over 18 years of age cited this as a way to lower their expenses. About 2 percent of all adults attempted to purchase medicines from other countries. However, 6 percent of adults between 18 and 64 years old tried alternative therapies, while just 2.3 percent of those 65 and old did so.

Some other findings: Among adults aged between 18 and 64 years old, 8.2 percent skipped doses and 8.5 percent took fewer medicines to save money compared with 3.1 percent and 3.9 percent, respectively, among adults aged 65 and over. And among adults betwen 18 and 64 years old, the uninsured - 23 percent - were more likely than those with Medicaid - 13.6 percent - or those with private coverage - 8.7 percent - to not have taken their meds as prescribed.

Among this same group, those who were uninsured were more likely to ask their doctor for a lower-cost medication to save money - or 24.3 percent - compared with those who had private coverage - nearly 19 percent - and those who had Medicaid, or 15 percent. Those who were uninsured were more likely to use alternative therapies to save money - nearly 12 percent - compared with those who had private coverage -4.2 precnet - ...Read more

More Med Schools Pass The Conflict-Of-Interest Test

esilverman — Tue, 09 Apr 2013 13:09:22 +0000

Those crazy kids are at it again. Once more, the American Medical Student Association has released its annual ratings of how medical schools interact with the pharmaceutical industry. The latest showing finds that 115 or 158 schools, or 73 percent, earned a grade of A or B for policies governing interactions between drugmakers and faculty and students. This is up from 102 that earning such grades last year.

However, the AMSA notes that only four medical schools - Commonwealth Medical College, Stony Brook University School of Medicine, Florida State University College of Medicine and University of South Dakota Sanford School of Medicine - ban sales reps from campuses, earning a "perfect" score. The student group, which next year plans to expand its survey to include 400 medical schools and teaching hospitals, says that interactions with sales reps is a "challenging" area.

Other findings: only 41 schools, or 26 percent, have "model" policies that require personnel to disclose past and present financial ties with industry - such as consulting and speaking fees and research grants - on a publicly-available website and disclosing these relationships to patients. Medical schools with model policies on speaking arrangements have grown to 44 schools, though (here is the scorecard with ratings).

The PharmFree scorecard, as it is called, emerged six years ago amid heightened scrutiny of the relationships between medical schools and drugmakers over concerns that student views and their future medical practices may be unduly influenced by conflicts of interest, including free meals and other handouts. Studies have found that, over the past decade, most students have had some interaction with drugmakers, but contact increased in the clinical years, with up to 90 percent of all clinical students receiving some form of educational material (...Read more

Another Blow To AstraZeneca: S&P Lowers Its Outlook

esilverman — Tue, 09 Apr 2013 12:13:22 +0000

Three weeks ago, Pascal Soirot unveiled a months-long effort to rebuild AstraZeneca, which he joined last fall as ceo amid a disheartening lack of new drugs and increased generic competition. His plan revolves around consolidating R&D and global marketing operations over the next two years, a move that will eventually eliminate 1,600 jobs by 2016 and save some $900 million annually. Earlier this year, Soirot also booted the former head of global commercial activities and created a new position to bridge R&D and sales (read more here).

Initially, the response to his plan was enthusiastic, at least among investors. Since the mid-March pronouncement, AstraZeneca stock has climbed roughly 20 percent. But not everyone is enamored with the planned changes. Standard & Poor's has revised its outlook for the drugmaker to negative from stable. Why? "We believe... the strategy will not halt the downward trend in revenue declines following blockbuster patent expirations," which is otherwise known as the patent cliff.

Specifically, S&P cites the well-known patent expirations looming for the Seroquel IR antipsychotic, the Nexium acid reflux pill and the Crestor cholesterol med, all of which face generic competition between 2014 and 2016. Meanwhile, the credit rating agency foresees a 9 percent decline in revenue this year. In the 'silver lining' category, S&P affirmed AstraZeneca's credit, thanks to an "above average" metric of earnings before interest, taxes, depreciation and amortization of about 37 percent last year. Then again, this was off from 43 percent in 2011 (here is the S&P statement, which requires registration to read).

The upshot is that S&P sees a one-in-three chance of lowering the long-term credit rating. The...Read more

Pharmalot... Pharmalittle... Good Morning

esilverman — Tue, 09 Apr 2013 11:58:11 +0000

Hello, everyone, and nice to see you again. Once again, we apologize for the recent inability to access the site. As you might imagine, we have not been happy either with the way the redesign was handled, but we are moving forward, as always, and quaffing another cup of stimulation to help us along. Please join us. After all, there is much to do. With that said, here are some tidbits to get you started. Meanwhile, thanks for your patience and please do stay in touch, especially if you hear something interesting...

China Reports Its Eight Bird Flu Death (Reuters)

Pfizer R&D Building Demolition May Be Delayed (The Day)

FDA OKs Morning Sickness Pill Withdrawn 30 Years Ago (Associated Press)

Roche Signs $392M Huntington's Deal With Isis (Pharma Times)

To Access China, Pharma May Have To Cut Prices (Bloomberg News)

New Amgen CEO Doubles His Salary (Associated Press)

Bayer PAH Drug Gets FDA Fast Track (Pharma Times)

Novartis And Ventner Work On H7N9 Vax With CDC (InPharma Technologist)

EDITOR'S NOTE: Please check this post for...Read more

The Pharma Reputation In the US And UK Is... Not So Good

esilverman — Mon, 08 Apr 2013 17:32:28 +0000

Earlier this year, a survey of 600 patient groups around the world found that the overall reputation of the pharmaceutical industry - or more specifically, 29 large drugmakers - had taken a nose dive. Only 34 percent reported that multinational drugmakers had an 'excellent' or 'good' reputation last year, according to Patient View, the research firm that conducted the survey. This compares with 42 percent in the 2011 survey of 500 patient groups.

As we noted at the time, 40 percent of the 600 patient groups believed industry reputation declined in 2012. The survey asked patient groups - some of which do receive financial backing of various sorts from the pharmaceutical industry - to rank 29 drugmakers on six indicators that influence corporate reputation: patient-centeredness; patient information; patient safety; useful products; transparency; and integrity (here is the back story).

For those of you with a US-centric view of the world, we now have more specific data that shows what 70 patient groups based in the US think of these large drugmakers. Only 29 percent felt the industry had a good or excellent reputation, which was below the 34 reported for all 600 such groups. And only 4 percent of the US groups believed drugmakers improved last year, compared with 21 percent globally.

In fact, 59 percent of the 70 US patient groups say that pharma is “excellent” or “good” at making high-quality, useful products compared with 63 percent globally. And 43 percent of US groups believed pharma is good at ensuring patient safety, compared with 48 percent in the global survey. But as many as 76 percent said pharma is only fair or poor when it comes to "having ethical marketing practices.” The figure in the global survey was comparable at 74 percent.

Meanwhile, only half of US groups say...Read more