EU OKs AstraZeneca, Bristol Diabetes Drug For Marketing

The E.U. granted marketing approval to a diabetes drug codeveloped by AstraZeneca PLC (AZN) and Bristol-Myers Squibb Co. (BMY), marking the first drug to be launched by the two together in Europe.

"The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca," said Beatrice Cazala, Bristol's Europe president. Ulf Sather, a top Astra official for Europe, said diabetes affects about 53 million people in that region.

Expected to go on sale in the E.U. this quarter, Onglyza - a once-a-day pill that treats Type 2 diabetes mellitus - was approved in July by the U.S. Food and Drug Administration. It launched in U.S. pharmacies in August with an average wholesale price of $5.72 per pill.

It belongs to a class of drugs known as DPP-4 inhibitors and competes directly with Merck & Co.'s (MRK) Januvia, which had the DPP-4 market to itself since 2006. Last month, the FDA said it was updating the labels of Merck's diabetes drugs Januvia and Janumet to discuss reports of acute pancreatitis seen in some patients.

The E.U. approved Onglyza to be sold for improving blood sugar levels in adults in combination with metformin, sulphonylurea or thiazolidinedione, when those drugs alone fail to adequately control glycemic levels accompanies with diet and exercise.

Recently, shares in AstraZeneca were up 1.2% at $44.18 and in Bristol-Myers Squibb were down 0.2% at $22.22.

-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; [e-mail]