Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Dec 7 2010

Columbia Laboratories, Inc. (Nasdaq: CBRX) and Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced positive top-line results from the PREGNANT Study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% vaginal progesterone gel to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy.

The administration of PROCHIEVE 8% vaginal progesterone gel was associated with a statistically significant reduction in the rate of preterm birth at less than or equal to 32 6/7 weeks gestation, the primary endpoint of the study, compared to placebo gel.  There was also evidence of improvement in infant outcome.  The incidence and profile of adverse events in patients receiving PROCHIEVE 8% was comparable to placebo, which was as expected given the product's documented safety history.  Further details of the study will be available at the time of publication in the biomedical literature after peer-review.

This study was conducted in collaboration with the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH).

"The primary result of this trial shows that vaginal progesterone reduces the rate of spontaneous preterm birth," said Dr. Roberto Romero, Chief of the Perinatology Research Branch of the NICHD/NIH.  "Preterm birth is a serious public health problem, affecting 10 to 12% of all pregnancies in the United States and costing approximately $26 billion per year."

"Based on the significantly lower incidence of preterm birth among women treated with PROCHIEVE 8% in this clinical trial, we believe PROCHIEVE 8% will be an important drug in helping to reduce the incidence of preterm birth.  We intend to file an NDA for PROCHIEVE 8% in this new indication in the second quarter of 2011," said Frank C. Condella, Jr., Columbia's president and chief executive officer.  "On behalf of the Columbia team, I want to thank the NICHD of the NIH for its collaboration on the PREGNANT Study, as well as the many physicians, medical professionals and especially patients who participated in this important study."

"Our market research has shown that short cervical length, as determined by transvaginal ultrasound, is the most powerful predictor of spontaneous preterm birth and women with a short cervix between 10 and 20 mm represent up to 5% of the 4 million births each year," said Fred Wilkinson, Watson's Executive Vice President, Global Brands.  "Results from the PREGNANT Study create a compelling reason for making transvaginal ultrasound a routine part of obstetric care to identify women at risk.  Additionally, the availability of a potential treatment such as PROCHIEVE 8% could represent the first meaningful clinical step in reducing preterm birth and the subsequent medical costs of responding to such pregnancies. If ultimately approved, the availability of PROCHIEVE 8% would represent a previously unavailable option in the physician's arsenal of responses, which currently focuses on extending pregnancy where possible and addressing infant care following premature birth."