Even with two products on pharmacists' shelves, diabetes drug developer Amylin Pharmaceuticals
Data released yesterday showed that product sales of its two drugs -- Byetta, which it markets with Eli Lilly
Research and development costs for its obesity drug pipeline and the extended-release version of Byetta, which Amylin is developing with Alkermes
Amylin's had a rough month thanks to the FDA. At the beginning of the month, the agency approved a pen formulation for Symlin, which the company plans to launch by the end of the year, but turned down a request to expand the label indication for use in patients using basal insulin. Then, earlier this week, the agency issued a warning letter that Byetta might be causing acute pancreatitis in a small number of patients. On the conference call, management said that there had been no cases of pancreatitis in the ongoing phase 3 trial of the extended-release version of Byetta; that's good news, since Amylin's future rests on the easier-to-take version.
In order to increase sales of Byetta, Eli Lilly and Amylin have recently initiated a "consumer education program" -- a euphemism for advertisements to tell patients to ask their doctors about Byetta. The more patients the company can get on the drug, the easier a time it will have competing against Novo Nordisk's
This quarter should bring news about how quickly Amylin can get into the black. Results from the clinical trial of the extended-release version of Byetta, as well as the Pramlintide weight-loss trial, are both expected during the quarter. Amylin's chances of gaining full-fledged drugmaker status rest on those results.