The past 18 months were not terribly kind toKevin Sharer. There were FDA warnings over health risks associated with the Aranesp and Epogen anemia meds and reduced Medicare reimbursement. Congress is investigating marketing practices. The SEC is probing a failure to disclose that a key clinical trial ended over safety concerns. There were layoffs. And he was named one of the worst CEOs.
But Kevin is unflaggingly optimistic and predicts the fallout from safety concerns and reimbursement cuts for its anemia meds should bottom out during the first half of 2009. And he tells The Wall Street Journal this should bolster Amgen's standing as it prepares for the anticipated approval and launch of denosumab, a new drug for osteoporosis, which may receive FDA approval next year.
Kevin acknowledges that the problems surrounding the anemia drugs amounted to about $1.5 billion in lost annual revenue and prompted the loss of about 2,000 jobs, or 10 percent of Amgen's work force. But he plans to tell investors at a meeting today that Amgen has emerged healthy from the most difficult period in its 28-year history.
The biotech, he tells the paper, is poised to be "among the top three in revenue growth and earnings growth" in the biopharmaceutical industry over the next five years, a period when many large drug companies will face added pressure because of patent expirations.
Analysts attending the Friday meeting are expected to ask whether Amgen will find a partner to co-market denosumab or sell it on its own. Amgen's current products are prescribed mostly by specialty physicians, and the company doesn't have a large sales force to promote denosumab to primary-care docs, who are most likely to treat osteoporosis patients, the paper notes.
George Morrow, Amgen's executive vp for global commercial operations, indicated Amgen is leaning toward marketing the drug alone in the US and co-marketing it in Europe and other international markets, according to the Journal.