Wednesday, November 05, 2008

Amylin - Byetta LAR: long wait for long acting

Shares of Amylin Pharmaceuticals have collapsed after it emerged that US regulators have rejected data for a once-weekly version of its diabetes drug Byetta.

The company has disclosed in a filing to the US Securities and Exchange Commission that Byetta LAR (exenatide), which is being developed with Alkermes and Eli Lilly, has fallen foul of the Food and Drug Administration. Specifically the agency has rejected data from studies meant to show that Byetta LAR batches made by Alkermes were comparable to batches made at Amylin's Ohio facility.

The latter firm said that “we are continuing discussions with the FDA regarding these data and various alternatives” to enable a New Drug Application submission by the end of the first half of 2009. However, if required to initiate a new clinical study to demonstrate comparability, the submission could be delayed.

This could mean that a regulatory filing may be pushed back to late 2010 or early 2011, a year later than Amylin had originally hoped for. It has high hopes for exenatide LAR, which uses technology from Alkermes which releases the drug over the course of a week, whereas Byetta has to be injected twice-weekly.

1 comment:

Anonymous said...

(twice daily)