By Kim Coghill
Cubist Pharmaceuticals Inc. said its pivotal Phase III trial for Cidecin, a drug analysts say could bring in up to $400 million annually worldwide, achieved its primary endpoint.
Cubist, of Cambridge, Mass., tested Cidecin (daptomycin for injection) in the treatment of complicated skin and soft tissue infections, and said the product reached its endpoint of demonstrating equivalency to comparator agents.
Jennifer LaVin, Cubist's senior director of corporate communications, said more details about the trial, named study 9901, will be forthcoming at the European Congress for Microbiology and Infectious Diseases on April 3 in Istanbul, Turkey.
Cidecin is daptomycin, a novel cyclic lipopeptide antibiotic derived from a fermentation product of Streptomyces roseosporous.
Study 9901 was designed to compare the efficacy and safety of Cidecin to either vancomycin or approved semi-synthetic penicillins in the treatment of complicated skin and soft tissue infection resulting from Gram-positive bacteria. Clinical successes include patients with resolution or partial resolution of clinically significant signs and symptoms associated with those conditions.
The randomized, prospective, evaluator-blinded trial included 564 patients at multiple centers outside the U.S.
Cubist is conducting a second pivotal Phase III study of Cidecin and expects enrollment to be completed in four to six weeks, with data available during the third quarter. Also, Cidecin is in Phase III studies for community-acquired pneumonia and complicated urinary tract infections.
LaVin said the company intends to file its new drug application in mid-2002 and might seek accelerated review.
Joel Sendek, a senior analyst with Lazard Freres & Co. LLC in New York, said potential sales, including off-label uses, could be worth up to $400 million as the product has no real competition. Zyvox, a product of Bridgewater, N.J.-based Pharmacia & Upjohn, and Synercid, from Aventis SA, of Frankfurt, Germany, "are similar, but not the same," he said.
Cidecin is expected to be on the market by early 2003, and research notes prepared by Lazard Freres & Co. said Cubist, formed in 1992, should be profitable by 2004.
Cubist in January signed a $44 million licensing agreement with Gilead Sciences Inc., of Foster City, Calif., to market Cidecin in the European Union plus Switzerland. (See BioWorld Today, Jan. 9, 2001.)
Gilead paid Cubist an up-front licensing fee of $13 million and Cubist is entitled to receive additional cash payments of up to $31 million upon achievement of certain clinical and regulatory milestones. Gilead also will pay Cubist a fixed royalty on net sales.
LaVin would not comment on plans for U.S. marketing.
Cubist's stock (NASDAQ:CBST) closed Wednesday at $22.875, down $1.50. n