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I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status

For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO. 

EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success.  The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.

The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.

In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.

Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.

Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.

The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!

Until next time...

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

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Remember when Amgen was the world’s largest and most profitable biotechnology company? That was way back in 2006 before its marketing and sales team got in trouble for “pushing” the sale of its erythropoietin (EPO) product Epogen and Aranesp beyond acceptable patient safety limits. This, along with a relatively thin new drug pipeline, has for the past five years or so relegated the company to second tier biotech company status.

To make matter worse, a company spokesperson mentioned its third-quarter earnings conference call today that the company is

 “...currently evaluating some changes within our Research & Development organization to improve focus and to reallocate resources to key pipeline assets and activities." This typically means that the possibility of layoffs is real. The last major restructuring of the company took place in 2007 and it resulted in the elimination of more than 2,000 jobs worldwide, including about 700 in Thousand Oaks.

This past June, Amgen announced plans to eliminate 134 jobs at two of its manufacturing sites in Colorado.

The company employs about 17,000 people, including about 6,200 in Thousand Oaks. Amgen also has research and development facilities in Thousand Oaks, South San Francisco,; Cambridge and Woburn, Mass.; Seattle; Burnaby, British Columbia, Canada; Abingdon, Cambridge and Uxbridge, Great Britain; and Regensburg, Germany.

In 2010, Amgen's revenue totaled $15.1 billion, while research and development cost $2.9 billion, according to the company. Its net profit last year totaled $4.63 billion, up slightly less than 1 percent from 2009.

Could this signal the beginning of the end of this once formidable biotechnology giant? If I was an Amgen employee I would be feverishly updating my CV right about now!

Until next time...

Good Luck and Good Job Hunting!!

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

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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Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

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

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A federal judge ruled that Amgen Inc. must defend itself against charges that it misled investors about safety concerns with its flagship anemia drug, Aranesp.

A US district court judge dismissed charges against five of nine Amgen officers and directors but left plaintiffs 30 days to amend their complaint in order to include those defendants. The investors, led by Connecticut Retirement Plans and Trust Funds, assert that positive statements made by company officials regarding the safety of Amgen's two anemia drugs, Aranesp and Epogen, were knowingly at odds with clinical studies that had raised concerns.

The plaintiffs assert, according to court filings, that they unknowingly purchased artificially inflated shares, between April 2004 and May 2007. In one instance, during its fourth-quarter 2006 conference call, Amgen announced results of a clinical trial that tested Aranesp in 939 patients with anemia from cancer. The Food and Drug Administration, according to court filings, described the study as "demonstrat(ing) significantly shorter survival rate in cancer patients receiving (anemia drugs) as compared with those (sic) receiving transfusion support."

Describing the results of the study during the conference call, Roger Perlmutter, a defendant and executive vice president of research and development, said, "We did not see a statistically significant adverse affect of Aranesp on overall mortality in this patient population, and so we conclude that the risk/benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative."

Sounds misleading to me! It is unfortunate that companies compromise their scientific integrity and corporate reputation simply to boost their stock price in the short term. I think companies are slowly learning that if they are dishonest or disingenuous with the American public that the public will soon lose confidence in them and their products. This, in turn, will lead to a decrease in sales and ironically a reduction in company stock price. As the old adage goes “Honesty is always the best policy!”

Until next time….

Good luck and Good Job Hunting!!!!!!!!!!!!

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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