Amylin $19, Alkermes gain ground on Roche drug delay
Amylin Pharmaceuticals, Alkermes shares rise as Roche diabetes drug faces FDA filing delay
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On Friday June 18, 2010, 10:29 am EDT
NEW YORK (AP) -- Shares of Amylin Pharmaceuticals Inc. and its partner Alkermes Inc. gained ground Friday after potential competitor Roche said it would face filing delays on a developing diabetes drug.
Amylin, Alkermes and Eli Lilly & Co. are awaiting a Food and Drug Administration decision on the once-weekly diabetes treatment Bydureon. Meanwhile, Roche said it will have to delay filing an application for taspoglutide by up to 18 months, citing safety concerns.
Shares of Amylin rose $2.72, or 16.5 percent, to $19.23 in morning trading while shares of partner Alkermes rose 97 cents, or 8.4 percent, to $12.53. Eli Lilly shares rose 15 cents to $34.54.
On Friday, Roche said it would delay filing a regulatory application because of a new risk-mitigation plan in the ongoing late-stage study of taspoglutide. The Swiss company said incidents of hypersensitivity reactions are higher than expected for the study population.
"Material delay to the filing of taspoglutide means that investor concerns here are now warranted," said Jefferies & Co. analyst Jeffrey Holford, in a note to Roche investors.
He now expects the drug to reach the market in 2014, a launch date he said was too late to matter, given the growing competition in the diabetes treatment field.
The competition includes Novo Nordisk's once-daily drug Victoza, which received FDA approval in January. Shares of Novo Nordisk rose $2.51, or 3.1 percent, to $84.30 in morning trading. Earlier shares traded at a 52-week peak of $84.55.
Bydureon is expected to be a direct competitor to Victoza, and the FDA is set to make a decision on the drug by Oct. 22. Bydureon is a long-lasting version of the twice-daily injection Byetta, which is made by Amylin and Eli Lilly.
Alkermes is contributing the long-lasting technology to once-weekly Bydureon.
Several newcomers to the diabetes drug market include the oral treatment Onglyza, made by Bristol-Myers and AstraZeneca, and Januvia, made by Merck & Co.
