Positive data from PROCHIEVE vaginal progesterone Phase III study published in peer-reviewed journal

Apr 7 2011

Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced the publication of Phase III PROCHIEVE® (progesterone gel) data in today's online version of Ultrasound in Obstetrics & Gynecology, the leading peer-reviewed journal of the International Society of Ultrasound in Obstetrics & Gynecology.

The published results indicate that administration of vaginal progesterone from the midtrimester of pregnancy until term in women with a premature cervical shortening as confirmed by transvaginal ultrasound significantly reduced the rate of preterm birth before 33 weeks gestation.

"The prevention of preterm birth is a major healthcare priority, and there are currently limited interventions available," said Roberto Romero, MD, Chief of the Perinatology Research Branch of NICHD/NIH and the Principal Investigator of the study.  "Our data are the first to demonstrate that an intervention can dramatically reduce the rate of early preterm birth (<33 weeks of gestation) and improve neonatal outcome. This was accomplished with vaginal progesterone without any evidence of a safety signal."

"Sonographic short cervix is a powerful predictor of preterm delivery.  Our data indicate that universal transvaginal screening of women in the midtrimester to identify patients at risk can be coupled with vaginal progesterone to reduce the frequency of preterm birth and improve neonatal outcome. The availability of such clinical option would represent a significant advance in the prevention of early preterm birth and its associated complications," concluded Dr. Sonia Hassan, Associate Professor at Wayne State University, Attending Physician at the Detroit Medical Center, and lead author of the report.

"We'd like to thank the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health and the investigators for their incredible collaboration and support throughout the study, development of the manuscript, and publication process, as well as the many patients who participated in this important trial," said Frank C. Condella, Jr., Columbia's President and Chief Executive Officer.  "The next key objective for Columbia is to submit an NDA for PROCHIEVE to the U.S. Food and Drug Administration (FDA).  We remain on track to meet this goal in the second quarter of 2011."

"As demonstrated by the positive results published today, we are convinced that the combination of cervical screening, together with PROCHIEVE therapy, if approved by the FDA, may result in significant clinical benefits and improved infant outcomes, and subsequent savings to the healthcare system," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "It is very gratifying to see the PROCHIEVE results published in an authoritative peer reviewed journal confirming the clinical validity and the robust nature of the study.  Now, with this important data broadly available for review by the scientific and medical community, we can work to educate health care providers on the benefits of cervical screening and ensure it becomes a standardized component of the prenatal care regimen, ensuring that pregnant women at potential risk are identified.  We are committed to working with Columbia to submit the NDA to FDA, and to work closely to achieve a thorough review of the data which we believe will ultimately support approval of this potential therapy."