PHARMACY

Metabolex, Sanofi-Aventis announce new partnership

BY Alaric DeArment

HAYWARD, Calif. French drug maker Sanofi-Aventis has made a deal with U.S. drug maker Metabolex to license and develop a new drug under investigation as a treatment for Type 2 diabetes, Metabolex said Friday.

The two companies will work together to develop drugs in pill form that modulate GPR119, a protein in the gut and pancreas involved in production of insulin. Such drugs are supposed to increase insulin secretion and stimulate the release of the hormone glucagon-like peptide 1 from the intestines. This action may offer Type 2 diabetes patients a way to control glucose and lose weight, Metabolex said.

The agreement between Metabolex and Sanofi includes MBX-2982, which Metabolex discovered and currently is in phase 1 clinical trials. Under the agreement, Metabolex will receive an upfront payment and potential milestone payments totaling up to $375 million, as well as potential royalties.

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Merck gets nod from FDA for Dulera

BY Alaric DeArment

WHITEHOUSE STATION, N.J. The Food and Drug Administration has approved a new drug by Merck for treating asthma in patients ages 12 years and older, Merck said Thursday.

The FDA approved Dulera (mometasone furoate and formoterol fumarate dihydrate), an inhaled, fixed-dose combination asthma treatment.

“Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,” University of Tennessee Health Science Center medical professor Michael Blaiss said in a statement on behalf of Merck. “Asthma control is an important treatment goal, and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients.”

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FDA approves Mylan’s version of Procardia XL

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved a generic drug made by Mylan for heart disease, Mylan said Thursday.

Mylan announced the approval of nifedipine extended-release tablets in the 30, 60 and 90 mg strengths. The drug is used to treat hypertension and angina.

The drug is a generic version of Pfizer’s Procardia XL. Branded and generic versions of the drug had sales of around $234 million during the 12-month period ended in March, according to IMS Health.

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