It's been a brutal summer for Amgen Inc. -- and the heat goes on.
After a series of regulatory setbacks, layoffs and financial jolts, the company faces additional hurdles over the next few weeks surrounding its top-selling anemia drugs, Epogen and Aranesp, which together accounted for nearly 50% of Amgen's sales last year.
Depending on how the next month plays out, Amgen's recent blues could begin to lift. But should some of the chips not fall its way, the company's fortunes and perhaps its two-decade-long status as the industry's leader will be more in doubt than they are today.
On Tuesday, the Thousand Oaks giant faces a highly anticipated hearing in front of a Food and Drug Administration committee. The panel could recommend restrictions on doses of the anemia drugs.
The FDA hearing comes just a week after a trial with high stakes for Amgen got underway in Boston. In that case, Amgen hopes to block a competitor's effort to get Amgen's patents on its anemia drugs voided. A verdict is expected by early October.
In July, the federal Medicare agency sharply reduced how the government reimburses for the anemia drugs. Amgen has criticized Medicare's decision as "incompatible with good clinical practice," and when the company last month announced plans to cut its workforce as much as 14%, it blamed the move partially on the Medicare decision.
Now, Amgen has begun -- with some success -- a high-profile push in Washington to get Medicare to reverse the decision.
Although such reversals are rare, the Senate passed a nonbinding resolution last week calling on the agency to reassess its new guidelines. Amgen stock -- which has fallen 25% since the start of the year -- climbed on the news.
"We are going to know a lot more about what the company's future looks like by early fall," said Les Funtleyder, a biotech analyst with Miller Tabak & Co. "I'm sure people inside the company are crossing their fingers."
In the meantime, all eyes are on Tuesday's hearing.
Dr. Rob Brenner, executive director of Amgen's nephrology medical affairs, said the company planned to make a strong case that its drugs are safe and effective when used according to their labels. "There is no question these therapies are beneficial to patients with kidney disease," Brenner said.
The FDA has approved Epogen and Aranesp to treat anemia in people with kidney disease. Aranesp is also approved to treat anemia associated with chemotherapy.
