PHARMACY

Momenta, Sandoz file patent suit against Teva over generic Lovenox

BY Alaric DeArment

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Momenta said Teva infringed two patents covering analysis processes for the drug enoxaparin sodium. Momenta co-developed and marketed enoxaparin under a partnership with Sandoz, the generic drug division of Novartis. The drug is a generic version of Sanofi-Aventis’ Lovenox.

Teva, whose application for its own generic version of Lovenox is under review by the Food and Drug Administration, denied that it infringed the two patents and said the lawsuit was “without merit.”

The marketing of generic Lovenox by Momenta and Sandoz became a hot topic because of its potential implications for the implementation of the regulatory approval pathway for biosimilars provided by the healthcare-reform law. Though the FDA classifies Lovenox as a pharmaceutical drug, its chemical complexity and manufacturing process mean it has more in common with biologics than with traditional pharmaceuticals, and experts said the FDA’s approval of the generic version could influence its approach to biosimilars in the future.

 

 

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Nonprofits urge for more means of addressing obesity epidemic

BY Alaric DeArment

@font-face {
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The Obesity Society and the Obesity Action Coalition said Monday that they were urging the FDA Endocrine and Metabolic Drugs Advisory Committee to consider the need for more measures against obesity as the committee reviewed an application for Orexigen Therapeutics’ anti-obesity drug Contrave (naltrexone and bupropion), with the review scheduled for Tuesday.

Obesity affects some 93 million Americans, but the FDA has turned down approval applications for two obesity drugs, including Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s weight-loss drug Meridia (sibutramine) be removed from the market due to safety concerns.

“We are deeply concerned about the effect that the FDA’s recent decisions will have for ongoing and future research into desperately needed new obesity treatments,” Obesity Society president Jennifer Lovejoy stated. “As the FDA’s advisers consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need.”

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Watson, Natco ink deal for generic Revlimid

BY Alaric DeArment

MORRISTOWN, N.J. — U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said Tuesday.

The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome. Myelodysplastic syndrome results from the bone marrow producing blood cells that are misshapen.

Under the agreement, the companies will share net profits. The companies said Natco may be the first company to apply for Food and Drug Administration approval, which would give the companies 180 days of market exclusivity once the agency approves the application.

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