Bristol-Myers, AstraZeneca recall 92K vials of Bydureon from EU

Bristol-Myers Squibb ($BMY) had to report disappointing numbers for its Type 2 diabetes drug Bydureon during its last investor call. Now it and its Bydureon partner AstraZeneca ($AZN) are having to report a recall of about 92,000 vials of the drug from 8 European countries.

The vials are being retrieved from the U.K., Germany, Romania, the Netherlands, Ireland, Sweden, Finland and Spain, said BMS spokesman Ken Dominski in an email to FiercePharmaManufacturing. The recall was issued because of concerns the vials in the affected batches had not been fully filled. He said there is little chance of there being any patient issues if they are short a bit on their dose. According to an announcement from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), an "in-depth review of manufacturing records" found at least one of the batches may have had a "very small number" of underfilled vials.

BMS picked up the once-weekly injected drug with its $5.3 billion acquisition of Amylin Pharmaceuticals ($AMLN) in August 2012. The drug is manufactured at an Amylin plant in West Chester Township, OH. According to Dominski, the "root cause was determined to be a temporary equipment abnormality that occurred during the manufacture of a single lot. The company is working to ensure all necessary corrective and preventative actions are taken to prevent this issue in the future." He said no other batches distributed in other markets were found to be short-filled and the companies do not expect supply issues.

The drug was approved to pretty high expectations in the EU in 2011 and in the U.S. last year, but so far sales have disappointed. In July, BMS ratcheted back its full-year earnings forecast. It has a plethora of revenue issues, like the loss of the patent on its Plavix blood thinner. But it had counted on Bydureon to help address some of the shortfall and so far it has done little to help. It turned in only $66 million in sales for the second quarter, missing at least some analyst forecasts for the drug. It posted $118 million in sales for the first half year.

- here's the MHRA recall notice
- read more from The Wall Street Journal