Columbia Labs hands over NDA to Watson
Columbia Laboratories (Nasdaq: CBRX) has transferred the New Drug Application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson Pharmaceuticals (NYSE: WPI).
Watson has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application as of February 10, 2012. The companies indicated that Watson is continuing to work with Food and Drug Administration in support of the review of the NDA.
The 2010 Purchase and Collaboration Agreement between Columbia and Watson contemplated the transfer of the NDA for the product which the two companies have marketed as Crinone (The Pharma Letter March 5, 2010).There are no incremental payments associated with the transfer, and Columbia maintains its financial interest in the product and its role in the companies' Joint Development Committee.
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