Tuesday, March 24, 2009

Cubist files IP lawsuit against Teva

By Mass High Tech staff

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Lexington-based Cubist Pharmaceuticals Inc. has filed a patent infringement lawsuit against Teva Parenteral Medicines Inc. (TPM), Teva Pharmaceuticals USA Inc. and Teva Pharmaceutical Industries Ltd.

TPM is looking for approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration for a generic version of daptomycin, sold as Cubicin (daptomycin for injection) by Cubist, before the Lexington biotech’s patent rights expired. Cubicin treats skin and bloodstream infections related to Gram-positive bacteria, and it’s the first antibiotic of a class of lipopeptides.

As a result of the lawsuit, the FDA cannot approve TPM’s ANDA for 30 months from Cubist’s February receipt of Teva’s Paragraph IV notification letter.

Cubist researches and develops drugs to treat “unmet medical needs in the acute care environment,” a release by the company reports. The company develops Conserv-1 and Conserv-2, human proteins to reduce blood loss volume from on-pump cardiothoracic surgery, currently in Phase 2 clinical trials, and two Phase 1 treatments for Clostridium difficile-associated diarrhea (CDAD) and multi-drug resistant (MDR) Gram-negative infections.