Columbia Laboratories, Inc. (CBRX)

[surf1944]

6:56AM Columbia Labs and Watson (WPI) receive complete response letter from FDA for progesterone vaginal gel 8%; says 'did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market' (CBRX) 0.73 : Columbia Laboratories today confirmed that, as expected, Watson has received a complete response letter from the FDA for its New Drug Application (NDA 22-139) 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. The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at </= 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval. On February 10, 2012, Columbia transferred NDA 22-139 to Watson. Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application