ARTICLE | Company News

Columbia Laboratories, Watson deal

February 20, 2012 8:00 AM UTC

Columbia transferred to partner Watson regulatory responsibility and an NDA in the U.S. for Prochieve vaginal progesterone gel to reduce the risk of pretern birth in women with short uterine cervical length in the mid-trimester of pregnancy.The transfer was part of the terms of the 2010 deal in which Columbia sold its progesterone programs, including U.S. rights to the gel, to Watson. Columbia said it will maintain its financial interest in the product as well as its role in the companies' joint development committee, and that the transfer did not trigger any payments or changes to the financial terms of the deal.

Last month, FDA's Reproductive Health Drugs Advisory Committee voted 13-4 that the benefit-risk profile of Prochieve does not support its approval in the indication and suggested that Columbia conduct an additional trial in the U.S. The partners said Watson is continuing to work with FDA on the NDA, which has a Feb. 26 PDUFA date (see BioCentury, Jan. 23). ...