Progesterone vaginal gel 8% NDA transferred to Watson

Feb 13 2012

Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that Columbia 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.  

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 FDA in support of the review of the NDA. 

The March 2010 Purchase and Collaboration Agreement between Columbia and Watson contemplates the transfer of the NDA. 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. 

"We continue to enjoy a strong working relationship with Watson, and believe this is the appropriate time to transfer the NDA," said Frank Condella, President and CEO of Columbia Laboratories, Inc. "As a result of this action, shareholders and other stakeholders can be assured that Watson will provide the resources available, as a result of its position as a $4.6 billion global pharmaceutical industry leader, to support continued progress of this application."

The FDA is expected to take action on the NDA by February 26, 2012.