It is business as usual for Alkermes (Nasdaq: ALKS) as it tries to bounce back from the Bydureon (exenatide extended-release for injectable suspension) disappointment, when the US Food and Drug Administration issued a complete response letter relating to the drug, which is under development with US drug major Eli Lilly (NYSE: LLY) and Amylin Pharmaceuticals (Nasdaq: AMLN) requesting additional information (The Pharma Letter October 20).
News that the diabetes drug is unlikely to reach market for at least two years sent Alkermes’ share price plummeting 28% on the day, a shock from which it has yet to recover fully. Despite the delay in a potentially huge income stream for the Massachusetts biotech, chief executive Richard Pops told EP Vantage, part of pharma and biotech analysis group EvaluatePharma, he remains focused on the company's pipeline of new products and addiction treatment Vivitrol, which takes the mantle as the company’s most important growth driver (Alkermes wins first round match with Vivitrol approval, October 13, 2010).
Alkermes is also collecting steady royalties on Johnson & Johnson's anti-psychotic Risperdal Consta (risperidone). While US demand has been cannibalized in the US because of the launch of J&J’s Invega Sustenna (paliperidone palmitate), it remains a “flywheel of revenue” that funds Alkermes' operations, Mr Pops says.
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