Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Stu... (rm birth (<33 weeks of gestation) and...)

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Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results

Date:4/6/2011

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