Columbia requests FDA Priority Review for PROCHIEVE progesterone gel NDA

Apr 27 2011

Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that Columbia has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.

In the submission, Columbia requested Priority Review, which is typically given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.  The FDA's goal for completing a Priority Review is six months, versus ten months for a Standard Review.  

"Premature cervical shortening is a powerful predictor of risk for preterm delivery.  At present, there are no widely accepted interventions to address this medical need," said Frank C. Condella, President and Chief Executive Officer of Columbia Laboratories, Inc. "The recently published PREGNANT study has demonstrated that the use of PROCHIEVE can significantly reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy and the study also provided evidence of improvement in infant outcome.  

"I want to thank the many people whose hard work and intense focus enabled us to submit today the NDA for PROCHIEVE, well within our stated time-frame.  We now await notice from the FDA on whether our NDA submission has been accepted for filing, as well as a decision on our request for Priority Review which, if granted, could result in an action letter from the FDA in the fourth quarter of this year," Condella concluded.

"The combination of cervical screening, together with PROCHIEVE therapy, if approved by the FDA, may result in significant clinical benefits in a population where there are currently no effective therapies," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "We are committed to working closely with Columbia and FDA during the review of the data submitted within the NDA, which we believe will ultimately support approval of this potential therapy."

The NDA submission includes data from two Phase III clinical trials evaluating the use of PROCHIEVE in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.

SOURCE Watson Pharmaceuticals, Inc.; Columbia Laboratories, Inc.