Europe's Bydureon approval is victory for Alkermes

Tuesday's European approval of Bydureon, Amylin Pharmaceuticals' once-weekly injectable type 2 diabetes medication, can be considered a victory for Waltham, MA-based Alkermes' drug-delivery technology that drives the product. As FierceDrugDelivery has reported before, previous failures of Bydureon--failure to gain approval by the FDA in the United States and a recent setback over a missed goal--are not necessarily failures of the Alkermes portion of the drug's recipe.

The weekly drug uses Alkermes's polymer microsphere technology to make it last longer.

The San Diego Union Tribune reports that the European approval had been expected since April, when Bydureon received an endorsement from the European Medicines Agency's Committee for Medicinal Products for Human Use. The Union Tribune also quotes an analyst as saying the approval makes Amylin an attractive target for acquisition.

"We believe the European approval increases the chances of Amylin being bought by either partner (Eli) Lilly or another suitor with a strong European presence," wrote John McCamant in his Medical Technology Stock Letter, according to the Union Tribune. "Lilly has bought out partners in the past after their drug received a European approval in anticipation of the coming U.S. approval."

That approval has twice been dashed over FDA concerns, the latest in October 2010, when U.S. regulators were worried about irregular heartbeats in patients with impaired kidney functions. It will not likely go back for U.S. approval until late this year or early 2012.

- read the news at FierceBiotech
- and a report from the San Diego Union Tribune
- more background on Alkermes and Bydureon can be found here and here