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;
joan.solsman@dowjones.com