Friday, September 20, 2013

AstraZeneca, Bristol Recall Bydureon Diabetes Drug For Under-Filled Vials

AstraZeneca PLC (AZN) and Bristol-Myers Squibb Co. (BMY) have recalled about 92,000 vials of their jointly marketed Type 2 diabetes treatment Bydureon in several European countries because some vials weren't fully filled with the long-acting medication.

The affected batches were recalled in the U.K., Germany, Romania, the Netherlands, Ireland, Sweden, Finland and Spain, said a Bristol-Myers spokesman. No batches distributed in other markets were affected and the companies don't expect any supply issues, he said.

There is little evidence that patient safety would be compromised as a result of injecting an under-filled vial, the spokesman said, and any health consequences would likely be minimal.

The Bydureon recall was issued after an "in-depth review of manufacturing records" indicated at least one of the batches may have had a "very small number" of under-filled vials, according to an alert distributed this week by the U.K. Medicines and Healthcare Products Regulatory Agency.

Bydureon is designed to be injected once-weekly to help people with Type 2 diabetes control their blood sugar. European drug regulators granted marketing authorization of the drug in 2011, while the U.S. Food and Drug Administration cleared it for sale in 2012.

Bristol-Myers and AstraZeneca have an alliance to co-market diabetes drugs. They obtained Bydureon via Bristol-Myers' $5.3 billion acquisition of Amylin Pharmaceuticals in August 2012, which AstraZeneca effectively helped to fund. Amylin previously had a partnership to co-market Bydureon with Eli Lilly & Co. (LLY), which transferred its non-U.S. Bydureon rights to Bristol-Myers earlier this year.

Bristol-Myers reported Bydureon sales of $118 million for the first six months of 2013, which comprises all U.S. revenue for the period, plus non-U.S. revenue beginning April 1, when Lilly's non-U.S. rights were transferred.

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