Pfizer Adds Kosan GI Program To Portfolio
This article was originally published in The Pink Sheet Daily
Executive Summary
Companies will initiate Phase I study for Kosan’s lead motilin agonist compound in early 2007.
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Pfizer gained access to a clinical candidate for gastrointestinal disease as well as a platform of other motilin agonist compounds in a licensing agreement with Kosan Biosciences, Kosan announced Dec. 20. Under the agreement, the two companies will collaborate on regulatory filings and initiation of Phase I studies of Kosan's lead motilin agonist candidate KOS-2187. Pfizer will be responsible for all development, regulatory and commercial activities related to compounds in the program. Pfizer plans to file a Kosan-developed clinical trial application with European regulatory authorities to enable first-in-human studies of KOS-2187 to begin in early 2007, Kosan said. Under the deal, Pfizer will pay $12.5 million up front to the Hayward, Calif.-based biotech. Kosan is eligible to receive up to $250 million for the successful development and commercialization of KOS-2187 for one indication, including $72.5 million in developmental milestones. The company would also receive royalties on worldwide sales. In addition, Kosan is eligible for additional development and commercial milestones as well as royalties on worldwide sales, should Pfizer develop KOS-2187 for a second indication or develop other licensed Kosan compounds. "Pfizer believes that the mechanism of action of KOS-2187 and its demonstrated activity as a prokinetic agent are significant indications of its potential as a new approach for the treatment of gastrointestinal diseases," Pfizer Senior VP-World Wide Discovery Research James Bristol said. During Pfizer's recent R&D briefing, the company said it plans to launch two externally sourced products per year beginning in 2010 (1 (Also see "Pfizer Plans Four New Products A Year Starting In 2011" - Pink Sheet, 30 Nov, 2006.)). At the beginning of this month, Pfizer also said it would accelerate partnering efforts following its decision to terminate the development of potential blockbuster cholesterol therapy torcetrapib (2 (Also see "Pfizer Terminates Torcetrapib Program" - Pink Sheet, 3 Dec, 2006.)). Kosan is also partnered with Roche to develop epothilone cancer therapies under a deal signed in 2002. Under the agreement, Roche has worldwide exclusive rights to market and sell KOS-862, which is in Phase II studies for breast cancer, and KOS-1584, in Phase I studies against solid tumors, as well as other compounds from Kosan's epothilone platform. Kosan has retained codevelopment and copromotion rights in the U.S. Kosan's proprietary polyketide pipeline also includes KOS-953 (tanespimycin), a heat shock protein 90 inhibitor the company expects to enter pivotal registration trials in the first quarter of 2007. Kosan has been granted orphan drug status for tanespimycin in multiple myeloma in both the U.S. and Europe. A second Hsp90 inhibitor, KOS-1022 (alvespimycin), will begin a Phase II trial in the first half of 2007. "Our strategy is to advance alvespimycin toward a registration path in HER2-positive metastatic breast cancer," the company said. - Shirley Haley ([email protected]) |