Columbia Laboratories' Provides Update on PREGNANT Study Publication
LIVINGSTON, N.J.--(BUSINESS WIRE)--Mar 30, 2011 - Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced that the Company expects results from the PREGNANT Study, a Phase III clinical trial evaluating PROCHIEVE® (progesterone gel), will be published in a respected peer-reviewed medical journal online next week, and in the journal's print edition thereafter. The Company will issue a press release at the time of the online publication.
Columbia and Watson Pharmaceuticals, Inc. (NYSE:WPI) reported in December 2010 that in this pivotal Phase III clinical trial, the administration of PROCHIEVE was associated with a statistically significant reduction in the rate of preterm birth in women with a short cervical length 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 was comparable to placebo, which was as expected given the product's documented safety history.
About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company's strategy is to fund new development projects through proof of concept, then partner for later-stage clinical development and commercialization. CRINONE® 8% (progesterone gel) is marketed by Watson Pharmaceuticals in the United States and by Merck Serono in foreign countries.
Columbia's press releases and other company information are available online at columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the timely publication of the study by this medical journal online and in print; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE® and PROCHIEVE® are registered trademarks of Watson Pharmaceuticals, Inc.
Contact: Columbia Laboratories, Inc.
Lawrence A. Gyenes, 973-486-8860
Senior Vice President, CFO & Treasurer
The Trout Group LLC
Seth Lewis, 646-378-2952
Posted: March 2011