Amylin Pharmaceuticals, jointly with Alkermes and Eli Lilly & Co, is developing a long-acting version of its injectable drug Byetta, known as Byetta (or Exenatide) LAR.

In a filing with the Securities and Exchange Commission (SEC), the companies stated that upon presentation of data in lieu of approval of this long-acting release version of Byetta - using Alkermes technology to allow the drug to be released as a once-weekly application instead of twice daily – the Food and Drug Administration (FDA) has stated it has found discrepancies between the versions of the drug used in clinical trials, produced at Alkermes´ manufacturing facility, and the version made at Amylin´s facility in Ohio.

Amylin said it is continuing discussions with the FDA regarding the data and various alternatives, to enable a new drug application submission by its mid-2009 target.

However, market analysts estimate that if the FDA waits to review the drug until data from the ongoing trials is available, or the FDA requests further trials, it could push full approval to 2011, about one year later than Amylin had forecast.

This week Amylin had other disturbing news: Eastbourne Capital, 12.5 percent shareholders in Amylin, through a Securities and Exchange Commission filing stated it has under consideration to request Amylin Pharmaceuticals be sold, as a way of improving shareholder value. (See networkmedica.com 11-04-08).

Amylin shares have dropped 68 percent this year, investors´ reaction to the fact that popular blockbuster diabetes drug Byetta (with sales in the U.S. alone of $ 370 million dollars in the first nine months of this year) has been linked to six deaths of diabetes patients from pancreatitis, a severe liver disease.