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Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 

One of the main reasons for the resurgence of the vaccine industry, was passage of US legislation that better-defined the legal obligations of vaccine makers and inclusion in the legislation of provisions that cap the size of awards made to persons claiming injury after vaccination. Another factor that contributed to the growing popularity of vaccines was emergence of the middle class in vast and concomitant improves in the healthcare systems of emerging markets that include South America, Asia and Africa. Unlike the mature vaccine markets in the US, Europe and Japan (because of low birthrates), the Asian, Latin American and African markets are poised for explosive growth over the next two decades.

In a recent article entitled “Vaccines-The Sustainable Blockbuster Business” Frost and Sullivan’s Senior Healthcare Analyst Barath Shankar Subramanian provides some interesting and insightful factoids about the vaccine industry. They are:

Pediatric vaccines are leading adult vaccines and represent the fastest growing segment of the global vaccine market

Europe is the world’s leading vaccine producer with over 90% of total production

The top five vaccine manufacturers (all big pharma companies) produce more than four-fifths of global vaccine revenues while other manufacturers (approximately 40) account for only one-fifth.

The North American market accounts for over 50 percent of the total spend on vaccines

North America and Europe supply only 14 percent of the world’s vaccine demand; the rest is met by suppliers in developing markets

Government investment, not-for-profit spending and industry alliances/ partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry

At present, there no fewer than 80 new candidates in late stage clinical development. Further, almost 40 per cent of the new vaccine candidates are for indications that currently have no vaccines on the market.  Finally, improvements in vaccine delivery are helping to drive the improved uptake of vaccines. For example, aerosols, transdermal skin patches, oral drops and even pills—all designed to eliminate needles and improve patient compliance and overcome cold chain supply issues are currently being developed.

From a business perspective—as far as sustainable markets go—the pediatric segment of the vaccine market is a clear winner. Currently, the leading global causes of vaccine-preventable, deaths for children under five include: pneumococcal disease, rotavirus, measles, Hemophilus influenzae b (Hib) infections, pertussis and tetanus. To that end, it is likely that governments in emerging markets will continue to add existing and new vaccines to government-mandated immunization programs. This is almost certain to propel the vaccine market to new heights over the next 10 years or more.

Until next time...

Good Luck and Good Job Hunting (think biologics!)

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In press release today, Merck & Co disclosed that it reduced the size of its global sales force by 12 percent in 2010. Ken Frazier, Merck’s newly appointed CEO, pointed out that cuts in sales force sizes in developed markets like the US and Europe reached almost 30 percent. Yet, despite these cuts, Merck reported that it was able to boost sales in its vaccine and pharmaceutical business units.

Merck, like most other big pharmaceutical companies, have drastically reduced the sizes of their sales forces in recent years. The cuts have been attributed to higher than expected product attrition rates, product recalls and changes in physician preferences. It appears that many physicians grew tired of repeated visits by multiple reps after they were no longer allowed to give gifts or buy lunches for physician office staff. Further, many industry analysts contend that the advent of web-based marketing, social media and medical reimbursement overhaul (doctors no longer have time for reps) have largely rendered most pharmaceutical sales reps obsolete!

Other factors contributing to the recent demise of pharma reps are thin drug development pipelines, tougher regulatory standards for drug approval and impending patent cliffs (generic encroachment) for many blockbuster small molecule drugs. Put simply, fewer drugs require fewer people to sell them.

I think the death knell for pharma reps may be a bit premature. Many physicians find that well trained and informed sales rep can be a great resource and helpful to their practices.  Nevertheless, looking on the bright side, there is a growing need for sales reps that possess the background and training to sell biotechnology products! That said, unemployed pharma reps may want to consider going back to school to get some biotechnology training. This training is frequently available at local community colleges and four year colleges and universities and online.

Until next time...

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

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Unlike most of its competitors, which are downsizing operations, the Swiss drug maker Novartis yesterday announced plans to double the size of a planned office and laboratory complex in Cambridge, MA. A company spokesperson said that the expansion which will cost $600 million was part of a plan to bolster Novartis’ research operations and strengthen partnerships with local universities and biotechnology start ups. 

Novartis, Cambridge, MA largest corporate employer, expects to hire an additional 200 to 300 employs over the next five years increasing the size of its workforce in the city to 2,300.

Cambridge has become a something of a Mecca to pharmaceutical companies looking to tap into scientific information and intellectual property at Harvard and MIT and forging alliances or partnerships with early-stage biotechnology companies. In addition to the Novartis Research Institute, other companies in and around Cambridge include Sanofi-Aventis—which, last summer, unveiled a $65 million expansion in Cambridgeport that will house a new cancer research division and create 300 new jobs—AstraZeneca, GlaxoSmithKline, Shire and Pfizer.

In addition to its plan to expand operations and R&D capability in Cambridge, Novartis has agreed to build a $1.0 billion complex of offices and laboratories in Shanghai, China. Novartis like most other big pharma companies is trying to leverage scientific information and talent anywhere in the world to bolster their rapidly dwindling drug pipelines. 

The upside of Novartis’ Cambridge project is that it will help to create new construction, support and additional pharmaceutical jobs and help the city weather ongoing recessionary times. Who knows; maybe this is a sign that the US economy is growing and good times may be just around the corner!

Until next time...

Good Luck and Good Job Hunting (I highly recommend Cambridge MA)

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The Pharmalot Blog reported today that a survey conducted by the outsourcing firm Challenger, Gray & Christmas shows that only 200 pharmaceutical employees lost jobs in August. This compared with the 2,023 jobs lost in July, 830 in June and the 6,943 in May. According to the post, this year’s job loss tally is 37,265 as compared with 53,004 in 2009.  Since 2007, it has been estimated that over 180,000 life sciences employees have lost their jobs.

While the slowing layoffs are encouraging, there are no signs that companies are going to be hiring in 2011 (unless you are willing to relocate to Asia). Further, while layoffs are slowing a big pharma companies, the number of scientists losing their jobs at biotechnology companies because of insufficient capital or merger and acquisition activities remains steady and will likely increase if Sanofi-Aventis purchases Genzyme and other biotechnology companies are purchased. For example, Pfizer announced today that it was purchasing FoldRx for an undisclosed amount. FoldRx’s pipeline contains preclinical and clinical candidates for investigational new drugs that treat diseases caused by protein misfolding. The acquisition is consistent with Pfizer’s intention to move into the orphan drug market.

From an historical perspective, the early 2000s was the golden age for life sciences employees in most Western countries. Unfortunately, the golden age has ended for Western employees and it appears that a new era for pharmaceutical and biotechnology employees is beginning in the Asia, South America and Africa!

Until next time...

Good Luck and Good Job Hunting

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Despite claims of its imminent demise, it appears that social media and all of its trappings are being embraced by the masses. According to a report issued last week by CTIA, the wireless industry association, the amount of data, in text, music e-mail and other activities surpassed voice calls on mobile devices in 2009 (this explains why you cannot purchase 95 per cent of Verizon Wireless phones without a mandatory $9.99 per month data plan).

While there is little difference between the number of cell phone subscribers in 2009 and 2010, the number of users going online is up across all Web categories. Most notably, visitors to social networking sites like Facebook, Twitter and Four Square increased 78 percent. However, a troubling trend is that 46 per cent more users are visiting reference sites like Answer.com or Wikipedia for information. Although these sites are excellent resources, it isn’t clear whether or not all entries have been adequately researched and thoroughly vetted.

The meteoric rise of social media over the past five years has caused many e analysts and media pundits to suggest that the frenzy may be abating and the death of social media may be near. However, the beauty of Web 2.0 as it metamorphoses into Web 3.0 (are we there yet?) is that social media tools and their acceptance are extremely unpredictable. Who would have thought two years ago that Twitter, the upstart microblogging platform would be currently challenging Facebook for social media supremacy. Another social media platform to watch is Foursquare. While I don’t “get” the popularity of Foursquare, I also didn’t get Twitter until I started regularly using it!

Finally, as Mark Twain wrote many years ago after reading his obituary in a newspaper “"The reports of my death are greatly exaggerated” so too are the premature assertions that social media may be dead.

Until next time…

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

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Japanese drug maker Takeda Pharmaceuticals announced today that it will slash almost 1,600 jobs or 28 per cent of its 5000 person US workforce. Most of the cuts will take place at the company’s North American headquarters (1400) in Deerfield, Illinois; the remainder (ca. 170) will occur at Takeda Global Research and Development Center in Lake Forest. These cuts represent a 20 per cent reduction in R&D employees at the site.

The layoffs, which are part of a restructuring of Takeda’s North American operations, are directly related to declining sales and the coming generic competition to its top-selling diabetes drug Actos. In addition to being Takeda's biggest revenue producer, Actos is the nation's top-selling brand name diabetes drug and was the 8th-best selling brand in 2009, generating $3.4 billion in U.S. sales, according to the most recent information available from market.

Despite rumors of job creation in other sectors of the US economy, pharmaceutical companies continue to shed jobs.

Until next time…

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

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Ed Silverman who runs the Pharmalot Blog yesterday posted an article that reports the average salaries, employment rates and job opportunities for persons working in the life sciences industry. The figures reported in the post were gleaned from an industry -wide bi-annual report conducted by the Biotechnology Industry Organization (BIO) and the Battelle Institute.

Some of the report highlights:

1. Average annual wages in the U.S. biotech sector were tallied at $77,595, compared to the $45,229 average for total private sector employment
2. Total employment in the U.S. bioscience sector has exceeded 1.42 million, with another 6.5 million jobs indirectly supported by biotech.
3. The annual growth in the biotech was 1.4 percent during the first year of the recession, despite a decline in total private sector employment of 0.7 percent
4. Since 2001, more than 176,000 jobs have been added in the research, testing and medical lab sector, with total employment in the sector now topping 558,000
5. California leads the US in the total number of life sciences jobs with 221,096 followed by New Jersey with 88,854, Pennsylvania with 80,929, Massachusetts with 72,627, and Texas with 64,964

The report predicts an annual growth rate of 1.5 percent for the life sciences industry until 2018. While not great, the industry continues to grow while others like banking, financial services, business etc continue to decline.

Maybe a career in the life sciences industry isn’t a bad idea after all!

Until next time…

Good Luck and Good Job Hunting!!!!

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One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories will hire nearly 1,500 marketing executives, expanding its sales team by at least 50%, to spur sales and regain its rank as India’s top drug maker. The recruitment push is among the biggest by an Indian drug maker in recent years.  Ironically, pharma sales reps are still being regularly layed off in the US.

The company plans to hire mostly medical representatives, regional managers and area managers by July to boost sales in the rural markets.  According to a Ranbaxy hiring manager “Ranbaxy is looking at new rural markets and deeper penetration in interior markets.”

Ranbaxy is owned by Japan’s Daiichi Sankyo which employs over 12,000 people in 46 countries.

Industry analysts suggest that Ranbaxy’s aggressive hiring push is a sign that the company is focusing on internal markets which are poised for exponential growth in the next few years. Also, Ranbaxy has had its share of legal and regulatory disputes over patents and generics drugs in the US and Western Europe signaling that the company may be pursuing those markets less aggressively than in the past.

Until next time…

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

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IMS Health, a market intelligence company that tracks US drug prescriptions, reported that the US sale of prescription drugs grew 5.1% in 2009 to $300.3 billion.

IMS identified the following key trends among the major therapeutic areas:

• Antipsychotics remained the top-selling class of medications in the U.S., with 2009 prescription sales of $14.6 billion, equal to the 2008 level.
• Lipid regulators continued as the largest therapy class in the U.S. by dispensed prescription volume, growing at a 5 percent pace to 212 million prescriptions dispensed in 2009. Sales of lipid regulators declined 10 percent last year to $13.1 billion, reflecting an ongoing shift toward lower-cost generic alternatives. Lipid regulators ranked #3 in overall sales in 2009.
• Proton pump inhibitors replaced lipid regulators as the second-largest therapeutic class in sales last year. Proton pump inhibitors sales totaled $13.6 billion, a 2 percent decline year over year, while dispensed prescription volume for this therapeutic class rose 5 percent.
• Antidepressants became the fourth-largest class in 2009, up from its #5 ranking the prior year, with U.S. prescription sales growth of 3 percent to $9.9 billion.
• Sales of antineoplastic monoclonal antibodies, a leading oncology class that includes Avastin^®, Rituxan^® and Herceptin^®, grew at a 9 percent pace in 2009 and ranked #6 in therapeutic class sales.

IMS also reported that use of generic products, including branded generics, continued to rise last year and now represent 75 percent of all dispensed prescriptions in the U.S., up from 57 percent in 2004. The total number of generic prescriptions dispensed increased 5.9 percent in 2009, while the number of branded prescriptions dispensed declined 7.6 percent.

While the US pharmaceutical and biotechnology industries continue to cry poverty, it appears that sale of prescriptions drugs continues to grow at a pretty good rate. Look for increased growth until 2014 when healthcare reform begins to kick in.

Until next time…

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

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According to an article that appeared in the Indian publication The Hindu Business Line, GlaxoSmithKline (GSK) is set to increase the size of its Indian marketing and sales force to better support the sale of vaccines and other specialty products. A company executive said that GSK will add another 200 people to its 2,250 member sales and marketing team.

GSK is repositioning itself to be more competitive in developing and emerging markets like India, China, Brazil and elsewhere. The announcement to increase the size of its workforce in India comes only a couple of weeks after the company announced massive global layoffs that would affect at least 4,000 GSK employees.

Hat tip to Ed at Pharmalot!

Until next time...

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

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Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

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

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According to a report released by the president’s Council of Economic Advisers the biggest gains in job growth by 2016 will be in the areas of healthcare and education services. Moreover, most of these jobs will require postsecondary education degrees mainly in the form of certificates and associates degrees. To meet this demand, the report argues for ways to improve the US education system so that American workers can more easily adapt to a more skilled-base economy.

The report also notes that manufacturing will continue its long term decline and that small growth will occur in the business and financial sectors of the US economy. Construction and transportation are likely to begin to grow once the economy improves. However, the largest demand and increases will occur in healthcare services, environmental-related occupations and in education service providers. Whereas other sectors of the economy have been battered by the recession, growth in the healthcare and educational services sectors have remained robust.

In the past, emphasis has been placed on obtaining a baccalaureate degree to garner gainful employment. While this trend will likely continue, explosive growth is expected for occupations that require only an associate’s degree or postsecondary education certificate. Growth in these types of jobs is predicted to outpace occupations that require a bachelor’s degree or higher.

The report also describes goals that must be met to improve the American postsecondary education system. These include: improving early childhood, elementary and secondary education; better school curriculums; closer collaboration between employers and educational institution to ensure that students learn the skills that they need on the job, better financial aid; and accountability for education and workforce programs that don’t work. I have long contended that both undergraduate and graduate programs in the life sciences introduce skill-based workforce development activities into their curriculums. Unfortunately, my attempts have fallen upon deaf ears. Perhaps this report will induce the administrators who can institute this type of change to take their “heads out of the sand”and take notice.

Until next time...

Good Luck and Good Learning!!!!!!

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From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: 

• IMS Health has readjusted the growth of the pharmaceutical industry in 2009 from 4.5-5.5% to 2.5-3.6% with sales expected to exceed $820 billion
• The size of the US pharmaceutical market is expected to contract by 1-2% in 2009
• Emerging markets like China, India and Brazil are expected to contribute to more than half of the global market growth in 2009 and sustain an average growth rate of 40% by 2013
• The size of the Middle East pharmaceutical market is predicted to exceed $18 billion by 2014

As one industry analyst put it “This high level of growth in emerging markets, combined with the contraction of the US market and ongoing low single-digit growth in other developed markets, is driving the pharmaceutical market to a new world order.” If I had money, I would be investing in generic pharmaceutical companies and follow-on biologic manufacturers!

Until next time...

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

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The New York Times reported today that for the first time, Internet users are spending more time on social networking and video sites than on e-mail. According to a report by Nielsen, there was a 1,905 percentage change in the time that users spent viewing online video and an 883 percentage increase in social networking use from February 2003 to 2009.

These changes represent something of a paradigm shift in consumer's relationship with the Internet. People are increasingly moving away from portal-oriented sites, like shopping directories to social networking sites like YouTube and Facebook and providers of niche content.

While marketers have yet to master advertising on social networking sites, Internet pundits and social media enthusiasts believe that over the next year or so a viable business model will emerge that is reliant on social networking user influence and opinions.

Until next time...

Good Luck and Good Networking!!!!!

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

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

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

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

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I was reading a post about the Exubera deal that Pfizer cut with Nektar the other day and I stumbled upon this tidbit–“The two companies will continue to jointly develop an inhaled formulation of PEGylated recombinant human growth hormone (rHGH) to treat growth problems”.

For those of you who may not know, protein PEGylation–developed about 30 years ago by Frank Davis and Abe Abuchowski at Rutgers University– involves chemically attaching polyethylene glycol (PEG) to proteins. PEGylated proteins are less immunogenic and circulate longer in the bloodstream than native, unPEGylated proteins. Protein PEGylation has revolutionized the biopharmaceutical industry because it reduces immunological side effects, improves clinical efficacy and enhances patient compliance (by reducing the number of injections that are required) for many protein-based drugs. Several companies including Schering Plough, Roche and Amgen have used protein PEGylation to create multibillion blockbuster a year biotechnology products like PEG-Intron, Pegasys and Neulasta.

Like most protein-based products, rHGH needs to be injected daily to achieve its desired clinical effects. At present, there are no fewer than 8 rHGH products on the market that are used to treat pediatric and adult growth hormone deficiencies. The holy grail of the growth hormone market is to develop a sustained-release version of rHGH so that daily injections are no longer necessary. To that end, several companies, including Nektar, have developed PEGylated versions of rHGH which are in various stages of clinical development. These products should hit the markets in Europe and the US within the next few years.

Although Pfizer is in the rHGH biz, it is puzzling (to me) why any company would consider developing an inhaled form of PEGylated rHGH –given all of the regulatory hurdles and exhorbitant development costs-when an injectable form of PEGylated rHGH would be far superior and offer greater patient benefits than any of the currently marketed rHGH products? Maybe I am missing something here. That said, the larger question is: Why hasn’t Pfizer learned that the inhaled protein market is a dicey one at best?  Maybe that's why Pfizer is still Pfizer!

Until next time….

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

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