An FDA advisory panel voted to recommend that EPO products sold by Amgen and Johnson and Johnson, which had over $6 Billion in sales in 2007, not be used in cancer patients with curative cancer (IE, the drugs can only be use in patients who are expected to die from their cancer). The move severely restricts the use of EPOs, however, the FDA's move was less severe than it could have been - investors were concerned the FDA would ban the drugs in oncology uses.
On Dec 7th, the FDA announced it would hold a new round of hearings on the safety of erythropoiesis-stimulating drugs, such as Aranesp and Epogen, which make up nearly half of Amgen's revenue. On Dec 10, researchers at the Mayo Clinic said the use of these drugs is associated with a higher risk of leukemia among people with a rare bone marrow disorder called myelofibrosis.
Amgen had high hopes to expand Aranesp's indications to cover more types of cancers. However, results of a Phase III study involving 733 breast cancer patients taking Aranesp did not find any benefit to the drug. Shares fell by 4.1% to $52.99 in pre-market trading.
Amgen won its patent infringement trial against Roche. Roche was planning to bring Mircera to market in fall 2007. Mircera would have competed with Amgen's Epogen and Aranesp, which stimulate the production of red blood cells. Epogen and Aranesp had combined sales of almost $7 Billion in 2006, and have no other competitors in some markets. Had Mircera come to market, it could have proved devastating to Amgen's revenues and market share.
An FDA Panel advised against restricting prescribing for Anemia drugs such as those sold by Amgen in patients with high hemaglobin levels.
In response to a series of safety issues that cropped up with top-seller Aransp, and resultant government cuts in reimbursement, Amgen announced lower earnings guidance for 2007 and layoffs of up to 14% of staff.
The Center for Medicare and Medicaid Services announced it would not reimburse for Aranesp used in oncology (a multi-billion dollar market for Amgen) unless a patient is so anemic that his or her hemaglobin levels fall below 10 grams / decileter. Amgen's drug is indicated for, and has been used by, patients with much higher hemaglobin levels. However, without reimbursement, doctors are unlikely to use the drug in those patients.
The FDA's Oncology Drug Advisory Committee (ODAC) recommended a series of actions in response to recent safety concerns about Amgen's erythropoietic drugs. These recommendations included additional clinical trials, label changes, restrictions on use in certain types of cancer, and restrictions on use in less severe patients, stoking investor concerns that Amgen's blockbuster drugs might be used less frequently, cutting into revenues.
Study results released April 19th found that patients taking Amgen's anemia dru Aranesp along with chemotherapy were no more likely to die than those not taking Aranesp. Although Amgen designed the study in the hopes of seeing a benefit for Aranesp, the neutral outcome was a win, coming after data in January and February suggesting cancer patients on Aranesp were more likely to die than their counterparts not taking the drug. The April 19 study results suggest Aranesp may be a safety risk only in limited patient sub populations and at elevated doses, rather than more broadly as was feared.
Data released in January from an Amgen sponsored study showed patients with cancer but not taking chemotherapy were at increased risk of death if they were takin Amgen's anemia drug Aranesp. A Danish study of patients with head and neck cancer released in February found similar results. While Anemia of Cancer is a relatively small ($500M / year) market for Amgen, the concern was that Aranesp might prove unsafe in a broader patient population, leading to either dramatically lower sales or even withdrawal from the market.
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