Tuesday, February 10, 2009

Cubist sues Teva over generic drug

By Mass High Tech staff

Cubist Pharmaceuticals Inc. has announced plans to file a patent infringement lawsuit against Teva Parenteral Medicines Inc., after receiving notice that Teva plans to issue a generic drug version of Cubist’s daptomycin for injection.

The Paragraph IV Certification Notice Letter from Teva indicated that the company had submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application (ANDA). If accepted, the generic version of Cubicin, a treatment for staph infections of the skin and blood, would pass before Cubist’s patents expire.

According to Cubist (Nasdaq: CBST) officials, the FDA must drop the acceptance of Teva’s ANDA if Lexington-based Cubist files a patent infringement lawsuit within 45 days of receiving the letter from Teva.

Growth of the company’s methicillin-resistant Staphylococcus aureus (MRSA) treatment, Cubicin, has consumed about a decade of Cubist’s resources. In 1997, Cubist acquired rights to Cubicin from Eli Lilly & Co. and won FDA approval in 2003. Getting it to market cost a half-billion dollars and Cubist just turned a profit two years ago. By the end of 2008, the company spent about $800 million on the testing and development of Cubicin.