Massachusetts-based Cubist Pharmaceuticals, Inc., a biopharmaceutical company formed in 1992, is focused on discovering and developing anti-infective drugs. Its lead product, Cubicin (a first in class lipopeptide), launched in November 2003 in the U.S., is used to treat complicated skin and skin structure infections (cSSSI). Cubist derives substantially all of its revenues from the sale of Cubicin: 94% of 2010 revenues came from US sales of the drug, and an additional 4% came from international sales.
In May, 2006, FDA approved the expanded label of Cubicin for the treatment of bacteremia (a blood infection) and endocarditis (a heart valve infection). Cubicin was also approved in E.U. for cSSSI in Jan 2006 and for bacteremia and endocarditis in August 2007. CBST purchased Cubicin's worldwide development and commercialization rights from Eli Lilly and Company in 1997 in exchange of royalties on product sales. The company has now partnered with Chiron Corporation (now Novartis) to commercialize the drug in the E.U. and some other international markets. Cubist partnered with AstraZeneca in Dec 2006 to develop and commercialize Cubicin in China and other Asian markets. In March 2007, it partnered with Merck & Co., Inc. to develop and commercialize Cubicin in Japan. Now the company has a full complement of partners ready to commercialize Cubicin around the world. Cubist receives royalties on these international sales. In February 2009, Teva filed an ANDA for a generic version of the drug, alleging that US patents 6468967 and 6852689 (expiring September 2019) are unenforceable due to inequitable conduct and that patent RE39071 (expiring June 2016) is invalid. This suit prevents the FDA from approving Teva's ANDA before July 2011 unless a verdict is reached before then.