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August 16, 2007
Biotech colossus Amgen, based in Thousand Oaks, CA, announced plans to cut back its staff as sales of some of their top drugs tumbled. In the action, more than 2,000 people will lose their jobs. Most of the cuts will be in manufacturing and in the research and development area. At the conclusion of these cut backs, staffing levels will be what they were in 2006. The company hopes to save more than $1 billion with this move.
Sales figures for three of the company's top selling drugs, Aranesp, Epogen and Procrit, have been falling since the FDA ordered a black-box warning for these drugs. The FDA ordered the change of the labeling on these products in March of this year. The official notice, posted on the FDA's web site states:
Audience: Oncologists, nephrologists, other healthcare professionals
[UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs.
Examples of the new labels can also be seen on the FDA web site.
The declining of Amgen's stock value in the past few months, from a high around $77 per share earlier this year to just over $50 as of this writing, has caused some of the company's investors to launch a class action suit against the company. The lawsuit, which is now being consolidated into one large suit by the firm of Schiffrin, Barroway, Topaz & Kessler based in Radnor, PA, claims that certain of Amgen's officers and directors violated the Securities Exchange Act of 1934 by marketing their drugs for off-label uses thus increasing the sales of these drugs while falsely inflating the price of Amgen stock.
Amgen has vigorously denied these allegations and plans to defend itself with the full extent of its resources.
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