The Impact of Consolidation on Pharmaceutical R&D

Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John  LaMattina PhD, a chemist, blogger, author and former President of Pfizer Global R&D.

In his article “The Impact of Merger on Pharmaceutical R&D," LaMattina asserts:

“Mergers and acquisitions of pharmaceutical companies over the past 15 years have had a major consequence on the internal research and development productivity of these organizations. Industry consolidation has eliminated a high degree of competition and resulted in the downsizing of internal research efforts. The execution of these mergers has caused a loss of momentum in the development pipelines of these companies along with loss of scientific talent.”

In addition, he believes that M&A and outsourcing of R&D operations has resulted in the loss of scientific talent required for innovation and development of novel new medicines. “Sadly, this loss of innovation comes at a time when we are trying to find treatments for challenging and difficult-to-treat diseases like Alzheimers and many cancers” says LaMattina.

While most life sciences executives believe that consolidation is good for business, LaMattina, along with John Lechleiter, the outspoken CEO of Eli Lilly& Co (who is also a PhD-trained chemist) believe that continued consolidation in the industry will have devastating consequences. “We are still very much opposed to a large-scale combination. We don’t think size is necessarily supportive of innovation.” says Lechleiter. 

LaMattina added “Downsizing R&D hinders the ability of companies to develop new drugs because they lack the scientific expertise required to make critical decision as a drug candidate makes it way through the pipeline.”

Unfortunately, most current pharmaceutical and life sciences executives don’t think like LaMattina. Since 2001, over 300,000 pharmaceutical employees, mostly R&D scientists and sales representatives have lost their jobs.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

Big Pharma Merger-Mania Continues at a Brisk Pace

I am certain that many of you may have noticed that the size of the life sciences industry is shrinking at an unprecedented rate. Big pharma companies flush with cash, near- empty pipelines and impending patent cliffs have embarked on a buying spree that is likely to continue for next years (or at least until the economy shows clear signs of resuscitation). Pfizer’s impending acquisition of King Pharmaceuticals is just another transaction in a long list of M&A deals that have occurred over the past three years.                             

According to an article in today’s NY Times, roughly $42.2 billion worth of pharma deals have been transacted so far this year. That number is close to the $45.8 billion in M&A transactions announced by the same time last year (excluding Pfizer’s acquisition of Wyeth and Merck’s purchase of Schering Plough). Unfortunately, these mega-merger deals almost always result in massive layoffs in the industry.

While blockbuster mergers may not be good for pharmaceutical employees, the behind the scenes players—investment bankers, brokers, advisers and consultants—make out extremely well. For example, according to an article in Pharmaceutical Technology Europe, over a three month period in 2009 pharmaceutical company merger and acquisition activities generated $500 million in advisory fees for investment bankers. Clearly, mergers and acquisitions are in the best interest of company executives and the investment bankers not pharmaceutical employees.

There is no question that the recession and the down economy are driving much of the M&A activity in the life sciences sector. And, industry consolation is to be expected during challenging economic times. However, while M&A may be in the best interest of pharma company shareholders in the short term, I don’t think it will help to insure American competitiveness and innovation in the life sciences over the long term. 

Until next time...

Good Luck and Good Job Hunting

Fred Hassan Shares His Views on the Past, Present and Future of the Pharmaceutical Industry

I just received a phone call from UK-based Meettheboss.TV to give me advance notice of an interview that was conducted with Fred Hassan, the former CEO of Schering Plough, that will be shown tomorrow at the Meettheboss.TV website. Hassan stepped aside as CEO after Merck acquired Schering Plough for $41.1 billion late last year.

Mr Hassan is arguably one of the most respected and highly visible pharmaceutical executives in the industry. He sat down with Meettheboss.TV to share how he was able to turn around a dysfunctional and failing Schering Plough and restore its tarnished image.

“I joined a company in 1997 that was in great difficulty.  There has been a merger between a Swedish company and a U.S. company, and that merger had resulted in a lot of difficulties, I was brought in as a CEO from the outside to try to make this merger work.  I realized that the future growth product of this company has been compromised in a deal that had to be untangled.” Fred told Meettheboss.tv

In an uncharacteristically candid interview, Hassan also offers his personal insights and views on the challenges that the pharmaceutical industry faces in the future as traditional business models begin to change and new players enter the pharmaceutical industry space. 

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To watch the full interview, please visit Meettheboss.TV

Until next time....

Good Luck and Good Viewing!!!!!!!!

Merck Giveth and Johnson and Johnson Taketh Away

I am attending the Annual Biomedical Research Conference for Minority Students (ABRCMS) in sunny Phoenix, AZ where I will be providing career development guidance to undergraduate and graduate students. Ironically, given the dismal job prospects in the life sciences industry for entry level employees, I will be giving a talk on how to find a job!  Last year's meeting in Orlando was a great one and I expect this one to be just as good.

While I am on the road, it doesn't mean that I won't be keeping track of the goings on back in my neck of the woods. To that end, Merck announced today that it will keep Schering Plough's corporate headquaters in Kenilworth, NJ open. Merck announced the decision today after closing on the $7 billion deal yesterday. This is good news for the NJ residents who currently work at the Kenilworth site. New Jersey has been extremely hard hit by all of the pharmaceutical layoffs in the past few years. Unemployment continues to rise and things will not get any better since conservative Republican Chris Christie was elected governor on Tuesday (he plans on laying off massive numbers of state employees) once he takes office in 2010.

Johnson and Johnson, on the other hand, announced that it was closing research & development facilities in Radnor and Chesterbrook, PA and consolidating those operations at the company's Spring House site. The New Brunswick, N.J., company would not say how many jobs are at those locations now or how many would remain in Spring House after the move, which is to be completed by 2012. These closure come shortly after JnJ announced earlier this week that is was elimating ca 8,200 employees or roughly seven percent of its global workforce.

Let's hope that things begin to improve soon. 

Hat tip to the Pharmalot blog!

Until next time....

Good Luck and Good Job Hunting!!!!!!

 

 

 

Johnson & Johnson Announces it Will Cut 8,200 Jobs

Johnson & Johnson announced today it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 

J & J joins a growing list of pharmaceutical and life sciences companies that have announced new layoffs. Pfizer Inc., the world’s biggest drugmaker, plans to fire 19,000 workers following its acquisition of Wyeth and had already cut 10,000 positions since 2007. J&J began firing as many as 4,400 employees from its pharmaceutical and stent divisions in late 2007. Finally, Merck recently announced that it will be eliminating 16,000 workers after its merger with Schering Plough closes later this year.

J&J’s announcement is more bad news for New Jersey which is still reeling from the earlier loss of tens of thousands of pharmaceutical and life sciences jobs.

Until next time...

Good Luck and Good Job Hunting (forget New Jersey)

 

Even More Consolidation in the Pharmaceutical Industry

The Belgian chemical manufacturer Solvay announced today that it had agreed to sell its pharmaceutical business unit to Abbott Pharmaceuticals for $6.6 billion. By purchasing Solvay, Abbott gains access to emerging markets in Eastern Europe and Asia along with new therapeutic areas, including hormone therapies and vaccines. Solvay's flu vaccine Influvac will give Abbott an entrant in the burgeoning vaccines market, which is currently dominated by European pharmaceutical giants like GlaxoSmithKline and Novartis.

Abbott already holds U.S. marketing rights for Solvay's Trilipix and TriCor, drugs which raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol.

Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston. It is not clear whether or not the Solvay purchase will affect ongoing pharmaceutical operations or staffing decision in the US. However, I suspect that there will be management changes and layoffs in Europe.

In other news, Johnson & Johnson bought an 18 percent stake in Dutch biotechnology company Crucell NV, which is trying to develop a universal flu vaccine, while competitor Merck acquired the rights to sell Australia-based CSL Ltd.'s Afluria flu vaccine in the U.S.

The Solvay deal is the latest in a string of mergers and acquisitions, as cash-rich pharmaceutical companies race to acquire new products amid looming patent expiry on blockbuster drugs. Earlier this year Swiss drugmaker Roche acquired Genentech following similar deals uniting Pfizer Inc. and Wyeth, and Merck & Co. Inc. with Schering-Plough.

Expect more M&A activity in the life sciences sector before year’s end.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Merck to Eliminate 16,000 More Jobs

As expected, Merck announced today that it would eliminate an additional 16,000 job after the merger with Schering Plough is completed. The combined company is trying to get its headcount down to around 90,000 employees. The new job cuts represent a 15% reduction in the workforce of the combined company.

While the merger may have made business sense, it doesn’t bode well for future employment for life scientists in New Jersey.

Until next time...

Good Luck and Good Job Hunting (are there any left?)

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Trouble with the Merck-Schering Plough Deal? Johnson & Johnson to Reclaim Marketing Rights to Remicade and Simponi

Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.

As you may recall, Merck was acutely aware of the terms of marketing agreement before it decided to purchase SGP and cleverly engineered the acquisition as a reverse merger— to prevent triggering provisions that could return Schering’s marketing rights for Remicade and Simponi to JNJ if their were leadership changes or a change of control at SGP. JNJ’s announcement contesting wasn’t unexpected after the Merck-Schering Plough deal was announced early last winter—sales of Remicade outside of the US topped $2.0 billion in last year. Simponi, Remicade’s highly touted successor (which recently received FDA approval), is also expected to reach blockbuster status after it reaches the market. 

The Merck-Schering deal left JNJ with few alternative or choices. The company could have counter offered to purchase SGP in its entirety or simply, as it did, invoke terms of the original agreement that would terminate SGP’s marketing rights if there was a “change of control” at the company. JNJ rightfully believes that a change of control will occur when Merck acquires SGP. According to a JNJ spokesperson “As its public statements make clear Merck is acquiring Schering Plough. The acquisition constitutes a change of control and trigger’s Centocor’s right to terminate.” It will be interesting to see how an arbitrator rules in the case.

While the loss of Remicade and Simponi isn’t likely to jeopardize the Merck-Schering Plough deal (according to Merck executives), it may affect the financial terms and overall benefit or upside of the acquisition. The expected completion of the deal is scheduled for the fourth quarter of this year.

Until next time...

Good Luck and Good Job Hunting!!!!

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Simponi--A New Anti-TNF-alpha Monoclonal Antibody--Garners FDA Approval.

The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection. 

Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.

I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

 

Why Downsizing May Hurt Pharma

Since 2007, approximately 80,000 pharmaceutical jobs have been eliminated. The recent consolidation in the industry, e.g., Merck-Schering, Pfizer-Wyeth and Roche-Genentech suggests that many more life sciences jobs will be lost over the next year or so. Typically, to avoid law suits and possible discrimination claims, most companies will layoff a mixture of experienced and entry level employees that cover the racial, religious and age spectra. For those of you who may not know, Americans who are 40 and older constitute a “protected class of employees.” In other words, companies that layoff employees cannot disproportionately give pink slips to employees 40 years of age or older. This law was enacted because older employees typically have higher salaries and have accrued more benefits and vacation time than their more junior counterparts and eliminating them can drastically cut costs. While most companies are careful to layoff a mixture of junior and senior employees during large layoffs, a quick perusal of the demographics of employees who lose their jobs reveals that many of them are older, more experienced workers. Sacrificing a few entry level employees (to prevent any red flags) is worth it to the accountants who charged with cutting costs and orchestrating large corporate layoffs.

Unlike consumer goods, pharmaceutical and biotechnology drug development is arcane, complex and may take up to 15 years to complete. There are many “go” or “no go” decisions that must be made during the drug development process. Typically, these decisions are rendered by experienced employees who have been “down the road” many times before and are able to recognize the oft-time nuanced attributes of successful drug candidates. Without the benefit of these employee and their experiences, drug companies may struggle to make the “right decisions” for new products being developed. Also, the loss of experienced employees can disrupt the flow of essential “corporate knowledge” to entry level and more junior employees. This is important because— while most entry level and junior employees are academically and technically qualified—it usually takes them years (under the tutelage of mentors and senior employees) to understand a company’s best practices. Put simply, the unrelenting loss of experienced pharmaceutical workers can alter the standing or dominance of pharmaceutical companies in certain therapeutic areas. While massive layoffs of experienced pharmaceutical employees bolster drug stock prices in the short term, the long term effects of these layoffs on the overall health of the pharmaceutical industry remains uncertain.

Jeff Kindler, Pfizer’s CEO, mentioned yesterday during a CNBC interview, that eight Wyeth senior executives will keep their jobs after the Pfizer-Wyeth deal closes later this year. Not surprisingly, he failed to mention how many “rank and file” employees of the combined company would keep their jobs after the merger. Don’t be shocked when Pfizer-Wyeth announces massive layoffs after the deal closes—Pfizer’s stock price has fallen 21% since it announced the Wyeth acquisition late last fall.

Until next time....

Good Luck and Good Job Hunting!!!

 

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Pharmaceutical Industry Consolidation: A Historical Timeline that Traces Big Pharma's M &A Activity

The old baseball adage which says that  “you can’t tell the players apart without a program” is particularly apt when it comes to tracing the M &A activity that led to the creation of some today's largest pharmaceutical companies.

I used to be able to keep track of all of the moving parts  of most of these mergers but advancing age and unprecedented M&A activity in the pharma industry prevents me from successfully doing this any longer. To that end, about a week ago, the New York Times published a pretty cool and informative chart that historically traces the corporate mergers that lead to creation of Pfizer, Novartis, GlaxoSmithKline, Sanofi-Aventis and others.

Check it out!!!!!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

The Weekly Pharma Merger Roundup

As you all know by now, Merck announced on Monday that it will purchase Schering Plough for $41.1billion in a deal constructed as a reverse merger. The reverse merger strategy was concocted to prevent the new company from losing the international sale rights to Remicade, Johnson and Johnson’s lucrative, blockbuster rheumatoid arthritis drug. According to the original deal inked by Johnson and Johnson and Schering Plough, Schering would have to surrender its rights to Remicade— which generated $2.1 billion in sales outside of the US last year —and golimumab (which is pending approval in Europe) if current ownership of Schering changes. Golimumab (CNTO 148) is Johnson and Johnson’s Centocor division next-generation human anti-TNF-alpha monoclonal antibody be developed as monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.  Since the merger was announced on Monday, Johnson and Johnson hasn’t issued any public statements about the deal—prompting some analysts to speculate that Johnson and Johnson may well make a counteroffer to acquire Schering Plough. Others believe that Johnson and Johnson will challenge the new company’s international rights to Remicade and golimumab despite the great lengths that Merck and Schering Plough management went to structure the acquisition as a reverse merger. Stay tuned for updates.

In other merger news, US-based Gilead announced that it will acquire CV Therapeutics for about $1.4 billion. The deal tops the hostile takeover offer from Astellas Pharma of Japan. Gilead, an HIV drug manufacturer is purchasing CV Therapeutics—which sells the cardiovascular drugs Ranexa (chronic angina) and Lexican (reduces stress during cardiovascular surgical procedures)—to expand its therapeutic repertoire beyond virology. The stock prices of shares of Gilead and CV Therapeutics jumped after the announcement signaling Wall Street’s approval of the deal.   Nevertheless, it may be premature for Gilead and CV Therapeutics to begin celebrating—Astellas may very well tender a counteroffer!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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The Merck-Schering Plough Deal Under the Microscope: Why a Reverse Merger?

Some of you may have been wondering why the$41.1 billion Merck-Schering Plough merger announced yesterday was designed as a reverse merger. For those of you who are not familiar with the reverse merger strategy, this is how it works. Generally speaking, a failing or failed publicly traded company that is listed on one stock exchange or another merges with a privately held company. The privately held company takes over the public stock listing and manages the day-to-day operations of the new business. Private companies that engage in reverse mergers are usually looking for cash infusions for product development or a stock listing (without going through an initial public offering) which offers it shareholders immediate cash value.  Investors who previously held stock in the public company are either compensated for their shares in cash or given shares (at a negotiated price) in the new entity. Any cash (or assets) left in the public company can be used to develop the formerly private company’s product(s) and if successful, shareholders in the old public company can eventually benefit. 

If reverse mergers are designed to bolster the prospects of private companies in need of cash why was the Merck-Schering Plough deal structured as a reverse merger? As I mentioned in a post yesterday, Schering-Plough markets Remicade outside of the US under an agreement with Johnson and Johnson which sells the drug in America. A termination clause in the original marketing agreement stipulates that the ex-US rights to Remicade (and another drug being developed) would revert to Johnson and Johnson if control or ownership of Schering Plough changes. Remicade, a treatment for rheumatoid arthritis, developed by Johnson and Johnson’s subsidiary Centocor, represented $2.1 billion in sales for Schering in 2008. Further, about 70% of Schering Plough’s revenue comes from outside the US. That said, the success or failure of the deal really hinges on whether or not Johnson and Johnson will challenge the change-in-control clause for Remicade. To obviate that possibility, Merck devised an unusual reverse merger strategy in which ownership of Schering Plough will not change hands—at least on paper anyway. Instead, even though Merck is putting up the money to purchase Schering, and Richard Clark, Merck’s Chairman and CEO, will run the newly combined company, Merck would technically become a subsidiary of Schering Plough and consequently there would be no change in Schering Plough management! Recall that Fred Hassan, Schering Plough’s CEO will remain with the newly formed entity during the transition. After the deal closes, Fred would step down as CEO, Merck’s current CEO—Richard Clark—would assume leadership and quietly change the name of the company from Schering Plough to Merck.

Of course, Johnson and Johnson could challenge the deal anyway, and if Merck was to lose in arbitration, it could possibly jeopardize the entire financial upside of the deal. Merck contends that even if it loses the rights to Remicade, the deal still makes sense.  Not so, said one Wall St analyst, “I think that is a lot of malarkey. You don’t take out 20 percent of a company’s revenue and their core international growth driver and say it is not worth anything,” he said. Other analysts think that the uncertainty over Remicade puts Schering Plough shareholders at a disadvantage and one response may be for Johnson and Johnson to make a higher bid for the company.  Still others believe that, while sale of Schering Plough makes sense, the $41.4 billion price offered by Merck is too low. Johnson and Johnson didn’t comment on the deal.

Schering Plough employees who I talked with yesterday after the deal was announced are not pleased with it either. They feel that Johnson and Johnson would be a more suitable partner and that Fred Hassan, who was under enormous shareholder pressure, had no choice but to sell the company as quickly as possible. It is not surprising that many Schering Plough employees would rather have the company sold to Johnson and Johnson rather than Merck. Unlike most pharmaceutical companies, Johnson and Johnson tends to leave the companies it purchases alone and runs them as wholly-owned after it purchases them.  Another reason why a merger with Johnson and Johnson makes more sense than one with Merck is that Johnson and Johnson has a very profitable consumer products division. This would be a better fit for Schering which has several highly visible and profitable consumer products like Coppertone and Dr. Scholl’s. In contrast, Merck sold its consumer products division years ago and will almost certainly divest itself of Schering’s consumer products division after the deal closes.

Now that Schering Plough is no longer in play, all eyes are on Bristol-Myers Squibb (BMS). BMS is about the same size as Schering Plough, has plenty of cash on hand and is thought to have a robust biotechnology pipeline. And, like Schering Plough,  it has been rumored to be a takeover target for the past 20 years!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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The Merck-Schering Plough Deal: More Bad News for New Jersey

Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey.

Merck currently employs 55,200 workers and Schering-Plough—which grew significantly with its purchase of Organon—also has about 55,000 employees. While no immediate job cuts are planned, a company spokesperson acknowledged that the size of the combined workforce will be reduced by approximately 15%-20% over the next year or so. This means that as many as 20,000 pharmaceutical employees may lose their jobs—a time when unemployment in NJ is approaching 10 percent! My sources tell me that Merck employees are already on edge because of surprise layoffs that occurred in early September, 2008. I suspect that employee anxiety will be extremely high at both companies for the foreseeable future—never a good thing from a productivity point of view.

According to press releases, Schering-Plough's shareholders will get $10.50 in cash and 0.5767 Merck shares for each Schering-Plough share they own. That's a 34 percent premium to Schering-Plough's closing stock price on Friday. Merck's top executive, Chairman and CEO Richard Clark, will lead the combined company, which will attempt to remain a dominant player in treatment areas including cholesterol, respiratory, infectious disease and women's drugs, as well as vaccines. Schering-Plough's CEO, Fred Hassan, will participate in planning integration of the two companies until the close of the deal, which is expected in the fourth quarter. The transaction is to be structured as a reverse merger. Schering-Plough will be the surviving corporation but will take the name Merck. The new company will remain at Merck's headquarters in Whitehouse Station, N.J. and a company spokesperson indicated that a "substantial majority" of employees of Schering-Plough will remain with the newly-formed company. The combined revenue of both companies in 2008 was $47 billion.

Mr. Hassan, a talented, “turn-around” pharmaceutical executive, took over Schering-Plough six years ago as chairman and CEO—a time when the company was struggling with a $500 million fine (the largest ever at the time) imposed by the US Food and Drug Administration because of chronic manufacturing problems. While Schering-Plough is now in much better financial shape than when Mr. Hassan first arrived at the company, its stock price is currently almost identical to the price when he took over (it lost 50% of its value in the past 18 months). Let’s see whether or not Richard Clark, Merck’s current Chairman and CEO, has the mettle to run the combined company. While Schering-Plough has long been rumored to be a takeover target, I don’t think that the Merck-Schering Plough deal is a particularly good or strategic one. Both companies have been struggling of late because of near empty drug pipelines and the ongoing brouhaha over Zetia, Vytorin and Merck’s Vioxx. Further, both companies face price reductions and slumping sales in the next year or so because several blockbuster drugs will lose patent protection and face stiff competition from generic drug manufacturers.

Like the Pfizer-Wyeth deal, the Merck-Schering Plough merger may little more than a red herring. I still fail to see how merging two oversized, struggling pharmaceutical companies can possibly result in the creation of a single successful one. The only upside of the deal is that it allows the newly-formed company to restructure operations, eliminate tens of thousands of jobs and cut costs to bolster its stock share price. That said, I don’t think that an artificially-inflated stock share price necessarily translates into the innovation that historically has been required to create new drugs to treat unmet medical needs!

Until next time...

Good Luck and Good Job Hunting (avoid NJ at all costs)!!!!!!!

 

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New Job Cuts at Bristol-Myers Squibb and Sanofi-Aventis and Merck Forecasts Poor Earnings for 2009

The Pharmalot blog reported today that Bristol-Myers Squibb will be laying off 5% of its workforce (~ 34 employees) by year’s end at its manufacturing facility near Syracuse, NY. And, Sanofi-Aventis announced that it will be giving pink slips to about 10% of its sales force —about 650 reps—before the end of the year.

To make matters worse, Merck released its annual revenue projections for 2009 today which suggest that its earnings and revenue will not meet Wall Street expectations. Merck recently “cleaned house” and eliminated thousands of scientific and mid-management jobs. The list of pharmaceutical companies that have downsized in 2008 includes Merck, BMS, GlaxoSmithKline, Novartis, Schering Plough, Boehringer Ingelheim, Wyeth and Sanofi-Aventis. I probably missed a few but who is counting?

Until next time….

Good Luck and Hold On to Your Job (if you can)

 

The Job Loss Carousel Keeps Spinning in New Jersey

The Pharmalot Blog reported today that Schering Plough will eliminate 1,000sales jobs or 20% of its sales force by October. This latest round of layoffs is part of a reorganization plan that was announced last year to cut 10% of it workforce by 2012 (although must of the downsizing will occur by 2010). The reorganization was announced shortly after Schering purchased Organon Biosciences and the “wheels came off” of its Zetia/Vytorin anti-cholesterol medication franchise.

In other news, BioJobBlog heard through the grapevine that Merck has been quietly laying off workers (since Labor Day) in an attempt to reduce its workforce by 20% over the next few years. Many very talented people who have been with Merck for years are looking for new jobs.

Finally, Montvale, NJ-based Memory Pharmaceuticals announced that it was laying off 55 workers or roughly 50% of its workforce. The company, which went public in a much heralded IPO in 2004, focuses on developing treatments for cognitive disorders. Although the company has never been profitable, the person who ran the company for the past three years (first as president, then CEO and finally CFO) earned $876,807 last year. Not surprisingly, he will be leaving the company as part of the downsizing initiative.

The ongoing pharma slowdown coupled with this week’s Wall Street meltdown (many people who work on Wall Street live in New Jersey) should make New Jersey a very challenging and interesting place to live in the coming months.

Hat tip to Ed at Pharmalot.

Until next time….

 

Good Luck and Good Job Hunting (I would avoid NJ)!!!!!!

More Job Cuts Expected at Bristol-Myers Squibb

Despite an increase in profits, BMS announced today that it will continue with its Productivity Transformation Initiative (PTI) that was instituted last fall. According to the PTI, BMS must save $1.0 billion over the next 2 years. Of course, the only way to accomplish this is by laying off employees whose jobs are not directly related to the process of transforming BMS into a “ next generation biopharma company” (Would somebody please write me and explain what that means)???? I suspect that BMS employees will be receiving “pink slips” after Labor Day.

This has been a devastating week for the NJ-based pharmaceutical industry. First, Teva announced last week that it will buy Montvale NJ-based Barr Pharmaceuticals and then earlier this week Roche issued a press release indicating that it will move its corporate headquarters from Nutley NJ to South San Francisco (Genentech’s headquarters) by 2010. The impending layoffs at BMS coupled with job freezes and downsizing at other NJ pharma companies like Schering Plough and Merck may signal the beginning of the end of New Jersey’s status as the “nation’s medicine chest.”

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!

Around the World: Corporate Downsizing Update

It’s summertime during a recession. What better time is there to give employees an extended vacation by announcing job cuts at the start of summer?  

Generic manufacturer Mylan announced that it is cutting jobs at a pharmaceutical manufacturing plant in central Puerto Rico. According to a company spokesperson, 100 jobs will be eliminated in coming weeks. Mylan had announced in February that it would be eliminating jobs at five locations as part of a companywide restructuring. The Pittsburg, PA-based company is the latest pharmaceutical company to announce cuts in Puerto Rico. The industry has eliminated more than 3,000 jobs here since mid-2006.

In other news, Palo Alto, CA-based Jazz Pharmaceuticals Inc. said Wednesday it plans to cut 8 percent of its work force -- or 33 employees -- primarily in research and development and administrative areas, and delay development of two drugs.

Finally, according to Ed Silverman over at Pharmalot, New Jersey-based Schering Plough has begun the massive layoffs it announced last April. As you may recall, CEO Fred Hassan still reeling from the Vytorin and Zetia flap, assured analysts and shareholders that he can right the ship by laying off about 5,500 employees or 10% of Schering’s workforce. He vowed to “consolidate management; use more shared staff support and services; reduce travel; cut sales and marketing; slash R&D; consolidate product lines, particularly in the animal health unit; and close some of the 60 manufacturing plants.” The previously announced job cuts are in addition to the 400 jobs that were eliminated after Schering Plough acquired Organon Biosciences.

Unfortunately, I guess it is going to be a long, hot, summer for the folks who lost their jobs.

Until next time….

Good Luck and Try to Hold On To Your Job (if you have one)

Enzon Pharmaceuticals Redux

It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

FDA Rejects Merck's New Cholesterol Medication

It seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.

Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.

Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper.  Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.

Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

The Enhance Trial Revisited

There has been some confusion surrounding the reporting of results from the Enhance Trial. As you know, the results from this study showed that the cholesterol-lowering drug Vytorin—a combination of Zetia and Zocor (a statin) —was no better than a generic version of Zocor by itself at controlling atherosclerosis.

In the Enhance clinical trial, 720 patients were treated with Vytorin or a generic version of Zocor and the amount of plaque that accumulated in the arteries of both groups was assessed by blood vessel imaging. Because Vytorin lowers LDL-cholesterol more than Zocor alone, both Schering –Plough and Merck (the companies that sponsored the trial) expected the patients who took Vytorin to have less growth of plaque in their arteries than those who took generic Zocor alone. As we all now know, this was not the case. In fact, there are some data which suggests that Vytorin treatment may actually enhance or promote plaque deposition and growth.

Since arterial plaque is closely associated with heart attack and stroke, the results from the Enhance trial led some to suggest that Vytorin doesn’t work any better than Zocor at preventing heart attack or stroke. While this may prove to be the case, there are currently no data to substantiate or refute this assertion. Those data will be generated in planned outcome trials that will measure the incidence of heart attack and stroke in patients taking Vytorin or Zocor. Merck and Schering-Plough began enrolling patients for these studies in 2006 and don’t expect any results before 2012. This may be too little, too late.

Merck and Schering have come under fire for not releasing the results from the Enhance trial in a timely fashion. A Congressional committee investigating the Vytorin controversy alleges that Merck and Schering Plough executives knew about the results of the Enhance studies at least two years before they released the data. The companies repeatedly delayed releasing the results of the trial, however, saying publicly that many of the images of the arteries were unclear and might need to be re-examined. Both companies have also have been criticized for delaying the initiation of the planned outcomes trials.

Shares of Merck and Schering-Plough plummeted yesterday following Sunday’s announcement at the American College of Cardiology meeting in Chicago.

Until next time….

Good Luck and Good Job Hunting (avoid NJ)!!!!!!!!!

Schering Plough Is In for a Rough Ride

An editorial published in this week’s New England Journal of Medicine and recommendations from an expert panel at an American College of Cardiology meeting being held in Chicago urged that the cholesterol-lowering medications Zetia and Vytorin should be used only as the last resort to treat patients with elevated LDL-cholesterol. Instead, the panel recommended that doctors and patients should use statins, older and sometimes cheaper medications, which have been clinically proven to lower cholesterol and reduce the risk of heart attack and stroke. The panel's recommendations were announced to the almost 30,000 physicians who were attending the conference.

As you may recall, Zetia and Vytorin, which reduce cholesterol levels by inhibiting its absorption from the intestinal tract, didn’t reduce the incidence of heart attack or stroke in patients taking the medications (in the Enhance clinical trial) even though LDL-cholesterol levels were lowered. Further, there is some emerging evidence which suggests that Zetia and Vytorin may actually speed rather than slow the development of plaque in arteries. Merck and Schering are conducting larger clinical studies (initiated in 2006) to measure effects of Zetia and Vytorin on heart disease and stroke. The results from these trials are not expected until 2012

Zetia and Vytorin are among the top selling drugs in the world with combined sales of $5 billion in 2007. Approximately 5 million people, including about 4.0 million Americans take the medications which were heavily advertised to US consumers. Many cardiologists believe that heavy marketing of the drugs has resulted in their over use. The fallout from the Enhance clinical trial controversy has already depressed the sales of both Zetia and Vytorin. A greater reduction in sales is anticipated as more doctors and patients digest the implication of the Enhance trial results.

The flap over the utility of Zetia and Vytorin will likely take a heavy toll on Schering Plough’s revenue stream. Analysts say that sales of Zetia and Vytorin produce almost 70% of Schering’s profits. The controversy will have less of a direct effect on Merck which co-markets Vytorin with Schering. However, Merck is still reeling from reports last week linking its popular asthma medication Singulair to suicide. 

Things are not looking too good in pharma land these days.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

Merck's Best Days May Be Behind It....Again

Oh, what a difference a couple of years or results from a pivotal clinical trial can have on a company’s financial outlook. As you may recall in 2005, Merck was in a shambles after the Vioxx scandal broke. Its CEO was ousted, its stock was trading at less than $35 per share and employee morale was at an all time low. After two short years, Richard Clark, a life-long Merck employee, was able to turn the company around. Merck’s stock reached a high of almost $61 last December and many of its employees were dancing in the streets of Rahway because their stock options were now worth more than the paper that they were printed on. But, like many things in life, all good things must come to an end.

Since December Merck’s stock price has plummeted to $40 and appears to be headed downward. What sparked the retreat was the release of results from the now infamous ENHANCE clinical trial which showed that Vytorin, which is co-marketed by Merck and Schering Plough, offered no greater benefit than a cheaper, generic version of Zocor (one of the two active ingredients of Vytorin) to reduce the risk of heart attack and stroke. The fallout from this revelation has been intense and dramatic. Both Merck and Schering Plough are being investigated by Congress for marketing violations and the financial maneuvers’ of several senior executives from both companies are under intense scrutiny. 

Many industry analysts believe that Merck may be on the ropes again and are afraid that the company may slip back into the morass it found itself in after the Vioxx debacle.

I have always held Merck in high regard–no fewer than 15 people who I went to graduate school have worked at Merck at one time or another. Further, the Merck name used to be synonymous with “second to none” science and outstanding pharmaceutical products. Sadly, over the past decade Merck’s leadership has consistently placed profits before good science causing the American public to lose confidence in one of its flagship pharmaceutical companies. Maybe Dick Clark, who was around during Merck’s glory days, can restore Merck’s reputation by insisting that from now on, good science will always come before corporate profits. Time will tell….

Until next time….

Good Luck and Good Job Hunting!!!!!!!

Merck and Schering Plough Fight Back to Calm the Cholesterol Controversy

Merck and Schering Plough have taken out two-page ads in several major newspapers defending their cholesterol drugs Zetia and Vytorin whose efficacy has been seriously questioned following release of data from a clinical study called ENHANCE late last week. The new ad campaign takes direct aim at the fallout from ENHANCE which showed that neither Zetia nor Vytorin (Zetia plus Zocor) is more effective in preventing heart attack or stroke than a cheaper generic version of Zocor alone.

The ad offsets the most important line in boldface: "All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN." And then it's "signed" by Robert J. Spiegel MD, Chief Medical Officer of Schering and Merck’s VP of External Medical and Scientific Affairs, Richard Murray MD. However, this advertising blitz may be too little, too late. Consumer and physician confidence in Merck and Schering Plough have fallen precipitously after the ENHANCE data were released last week.

According to various sources, the companies reportedly spent more than $100 million on a highly visible, slick marketing campaign to promote Vytorin and Zetia last year. Who doesn’t recognize the ubiquitous commercials with the folksy violin music and the "colorful" relatives dressed to look like food to accentuate the point that cholesterol levels are related to family history (genetics) and the foods that one consume. They have taken a new tact with today’s ads which showcase a matter-of-fact advertising approach. We'll see if it the new, less flamboyant advertising campaign can staunch the hemorrhaging that it taking place today at both companies.

Until next time…

Good Luck and Good Job Hunting!!!!!

Something is Definitely Fishy: Congress Announces Plans to Expand Vytorin Probe

I want to thank for his intrepid reporting on the Vytorin scandal and keeping BioJobBlog abreast of all late-breaking news and rumors that are flying about. 

In today’s post Ed reports that  “…..the House Energy and Commerce Committee wants to know more about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services (CMS), given the Enhance trial results showed the drug wasn’t more effective than cheap generic versions of Zocor, which is part of the Vytorin combo therapy.

The congressmen leading the probe - John Dingell and Bart Stupak, both Democrats from Michigan - sent separate letters today seeking all sorts of info from CMS and Schering-Plough. Already, they’re looking at whether Merck and Schering-Plough concealed or manipulated clinical trial data, given that the release of the Vytorin data was delayed nearly two years and the primary endpoint was briefly changed without the consent of the lead investigator. The probe is also focusing on the heavy advertising for Vytorin.

The Vytorin scandal coupled with the Vioxx debacle has done little to instill any consumer confidence in the pharmaceutical industry or the US Food and Drug Administration. Industry’s growing involvement in the drug regulatory approval process coupled with the Bush Administration’s intentional destabilization of FDA has resulted in the recent approval of drugs with dubious therapeutic efficacy and questionable safety profiles. 

Pharma has made it abundantly clear that profits are more important than patients’ health or safety. It is time for the Congress and the American people to stuff the corporate genie and its unbridled avarice back in the bottle!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

Lowering Cholesterol May Not Benefit Fred Hassan or Schering Plough

Fred Hassan joined Schering Plough as its CEO five years ago. At that time, Mr. Hassan inherited a company that was being investigated by FDA for regulatory compliance violations and the SEC was investigating it former CEO for investing and accounting irregularities. Since his arrival at the company, Mr. Hassan increased sales of key products, filled an empty product pipeline and returned profitability to a company that posted losses in 2003 and 2004.  

Much of his success can be attributed to Zetia and Vytorin, cholesterol-lowering drugs Schering Plough sells jointly with Merck & Co. Zetia lowers blood cholesterol levels by preventing absorption of dietary cholesterol from the gut. Vytorin is a combination product that contains Zetia and Merck’s statin drug called Zocor. Statins help to reduce blood cholesterol by inhibiting its production in the liver. Sales of both drugs have doubled to $5 billion a year since 2005. But that rich revenue stream is at risk following this week's disclosure that results from a large scale clinical trial called ENHANCE (which was initiated in 2002) showed that Vytorin did not reduce the incidence of atherosclerosis or lower the risk of heart attacks or strokes.

Schering and Merck said Monday that results of the now-controversial ENHANCE study showed that Vytorin failed to slow progression of heart disease more effectively than simvastatin generic form of Zocor that is sold at a far lower price. After learning about the results of the study, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic  quipped "Here we are, six years after this drug was marketed and promoted with a massive marketing campaign and has become a $5 billion drug" without evidence that it works as well as a statin. Now, "the first trial we have, is reported much too late and doesn't show really any evidence of benefit."

As reported in the Wall Street Journal “The impact of the finding was amplified by a long delay in releasing the results, and the revelation in November that the researchers considered altering the study's primary goals -- widely considered a violation of scientific protocol. The developments exposed the companies to suspicions -- which they have denied -- that they had postponed announcing the results because they were unfavorable. Also, the results of the Enhance trial were announced at a press conference rather than published in a peer reviewed scientific journal.”

“The missteps are likely to dent the companies' finances and reputation. Congress is investigating whether the companies improperly deferred publicizing the results, and yesterday lawmakers expressed concern about Vytorin ads. In addition, prominent medical professionals have questioned the drug's benefits.”

The fallout from ENHANCE is having other negative effects and possible long term consequences at Schering Plough. Yesterday, for example, widely circulated reports questioned the timing of stock trades made by the president of Schering's pharmaceutical division, Carrie Cox, in April and May 2007 that totaled about $28 million. Also, yesterday, leaders of the House Energy and Commerce Committee widened their investigation of the Enhance trial disclosure to include Ms. Cox’s stock sale and the high-profile Vytorin "food and family" ad campaign (the ones where people are dressed to resemble the food that they can eat while taking Vytorin).

Investor unrest is focused less on Merck than on Schering, whose bottom line relies much more on the drugs than Merck's does. Analysts estimate that Vytorin and Zetia account for more than half of Schering's earnings. Other analysts estimate the figure is closer to 60% for 2007, compared with about 15% in 2007 for Merck.

The big question that still remains is: If Vytorin has no greater benefit than a statin, why did FDA approve it? The drug was approved by the Food and Drug Administration based on its ability to reduce low density lipoprotein cholesterol (LDL). As is the case with many drugs the agency didn't demand proof that using the drug actually reduced the risk of heart attacks or stroke. Instead, they relied solely on surrogate markers like LDL cholesterol levels.

The Enhance results are now part of a larger debate over what kind of evidence the FDA should require before approving a drug. Drug manufacturers argue that studies that answer questions about heart attacks, strokes and mortality can take many years, thousands of patients, cost millions of dollars and would lead to prolonged delays getting a drug to market. Consequently, drug companies should be allowed to use surrogate markers to prove drug efficacy. Using this logic, it appears perfectly reasonable for drug manufacturers to bring expensive, new drugs to market (to increase profits and bolster their stock prices) despite the fact that they offer no greater health benefits than cheaper generic versions of similar drugs! According to FDA regulations, drugs will be approved only when available evidence indicates that they are SAFE and EFFICACIOUS —not one or the other!

Until next time…

Good Luck and Good Job Hunting (I would avoid New Jersey for now)!!!!!!!!!

Update on the PEGylation Wars: Schering Plough vs Roche

There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

Good Luck and Good Job Hunting (try Schering Plough)!!!!!!!!!

Once Again Merck Chooses Sales Over Patient Safety

There is a storm brewing around Zetia, Merck and Schering Plough’s blockbuster cholesterol-lowering drug. However, let me preface this post by reminding everyone that all drugs have side effects and if a drug’s benefits outweigh its risks then it will likely be prescribed to patients. That said, new evidence has been uncovered which shows that Merck, and  Schering Plough, conducted  at least 8 clinical trials from 2000 to 2003– to evaluate Zetia’s risk to the liver when taken with other cholesterol-lowering drugs (statins) – but chose to not publish the results of those studies. This is what we know about Zetia:

  • Zetia has annual sales of over $ 5 billion
  • Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. A 10,000 patient Zetia clinical study called ENHANCE is currently underway to determine whether the drug’s ability to lower cholesterol really translates into a reduction in heart attacks and strokes
  • Millions of people who take Zetia also take statins such as Zocor, Lipitor, Pavachol, Crestor and Mevacor to lower cholesterol (Vytorin, Merck’ new cholesterol-lowering drug contains Zetia and Zocor in a single pill)
  • From 2000 to 2003 Merck and Schering Plough conducted 8 long-term safety studies of Zetia in combination with a variety of statins but only published the results from 3 of the 8 studies. Also, the unpublished studies were not listed on industry websites where companies are supposed to register by law the results of all ongoing clinical trials after 2002 (because some of these trials were initiated before 2002 the law does not apply to them)
  • FDA supposedly reviewed the results of the unpublished studies and approved Zetia use with statins anyway
  • Prior to its approval in 2002, at least one internal FDA reviewer recommended that Zetia not be approved for use with statins because the combination caused liver disease in animals. Also, since 2006 a number of case reports have been published in medical journals that suggest the combination of Zetia and statins has caused severe liver damage in some patients
  • In the US, Zetia’s product label only contains mild warnings about the drug’s potential to cause liver damage. However, since 2005, product labels in Canada and Australia have carried strong warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression—warnings that have seemingly been ignored in the US
So what do Merck and Schering Plough have to say about the results of the unpublished safety trials? According to the New York Times, Dr. Robert J. Spiegel, Schering Plough’s Chief Medical Officer said “The companies had not considered the studies scientifically significant enough to publish their findings. Some may eventually be published.” Similar statements were made by Merck executives about Vioxx’s safety after they pulled it from the market! Not surprisingly, most of the safety studies that were published by Merck and Schering Plough generally played down the liver problems associated with Zetia and statin combination therapy.

Although many physicians still think that Zetia is safe, I believe that the failure of Merck and Schering Plough to promptly and openly disclose all research about the drug may be leaving the American public with a misleadingly favorable view of Zetia’s safety and efficacy (sort of like Vioxx). For the past 8 years or so, FDA has been slow in issuing safety warnings and demanding label changes for many widely used drugs like Merck’s pain killer Vioxx, GSK’s diabetes medication Avandia and Lilly’s anti psychotic drug Zyprexa that have turned out to carry serious safety risks. I think that it is time for FDA to “step up to the plate” and do its job—provide Americans with SAFE and efficacious medicines. Also, I hope that pharmaceutical companies are beginning to realize that they must be more forthcoming about the safety of their products if they want Americans to use them. Finally, and perhaps most importantly, drug company profits should never come at the expense of patient safety—NEVER!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

Happy Thanksgiving--Pharmaceutical Companies are Cutting Jobs and Closing Manufacturing Facilities in Puerto Rico

Pfizer said on Tuesday it will eliminate another 40 workers from factories in Puerto Rico. Pfizer closed a plant in Arecibo, Puerto Rico in 2005 and last year announced 210 layoffs in the U.S. Caribbean island territory

As pointed out by Ed Silverman over at Pharmalot, Puerto Rico has long been a manufacturing hub for US pharmaceutical companies. Over the past 30 years, pharmaceutical manufacturing has accounted for a quarter of the island’s gross domestic product and currently employs about 20,000 Puerto Rican citizens.

Over the past few years, companies like Watson Pharmaceuticals (generics), GlaxoSmithKline, Teva (generics), Bristol Myers Squibb and Schering Plough have either closed or will close manufacturing facilities on the Island. These closings were somewhat surprising because the Puerto Rican workforce is one of the best pharmaceutical manufacturing workforces in the world. That said, US pharmaceutical companies are looking elsewhere to produce their drugs because of rising wages, changing tax structures and the high cost of electricity (supplied by oil-fired power plants) on the island. Further, over the past decade, there have been ongoing compliance and quality assurance problems at many of the shuttered manufacturing facilities. Officials from these companies explained that it was less costly to shut down and move operations elsewhere rather than modernize the plants and bring them into regulatory compliance.

Despite these recent facility closings, the island’s pharmaceutical manufacturing industry still produces 13 of 20 best selling drugs in the US. However that number will likely continue to dwindle over the next few years. Many companies that have closed or are considering closing production facilities are moving operations to Asian destinations like Singapore, China, Thailand (and even Vietnam) where there are trained workforces, lower wages and cost structures and many people speak English.

Unlike most pharmaceutical companies, Amgen, Abbot and Lilly recently built or relocated biomanufacturing operations to Puerto Rico. Because of a trained workforce and Puerto Rico’s ongoing familiarity with FDA regulatory requirements, I suspect that other biotechnology and specialty pharmaceutical companies will consider establishing biomanufacturing facilities in Puerto Rico– pharma’s loss may well be biotech’s gain!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!