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Columbia Laboratories to Release Top Line Results of Phase II Lidocaine Study in Late September

Posted on: Monday, 8 September 2008, 09:00 CDT

Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced that its third party data management consultants have confirmed that the results from the Company's recently completed Phase II clinical trial evaluating vaginal lidocaine for the prevention and treatment of dysmenorrhea (a condition typified by painful menstruation) will be available on or before September 29, 2008. The Company had previously expected top line data to be available at the end of August.

Robert S. Mills, Columbia's president and chief executive officer, commented, "While in early August I believed that the final results would be ready by late August or early September, we learned on Friday from our data management consultants that the final statistical analysis, including required quality control checks, will now be completed on or before September 29(th). In the meantime, the study remains blinded until final analysis is complete. We look forward to reporting the results immediately following the conclusion of the data analysis."

About Columbia Laboratories

Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women's healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) and PROCHIEVE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. The Company's partners market CRINONE(R) 8%, STRIANT(R), and three other products to additional U.S. and foreign markets. The Company's research and development programs include the PREGNANT (PROCHIEVE(R) Extending GestatioN A New Therapy) Study of PROCHIEVE(R) 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy and a vaginal lidocaine product to prevent and treat dysmenorrhea. For more information, please visit www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will,""plan,""expect,""estimate,""should," and similar expressions. Such forward-looking statements involve certain risks and uncertainties; actual results may 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 successful marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8% (progesterone gel), and STRIANT(R) (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE(R) 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the clinical studies of our vaginal lidocaine product candidate and the ongoing Phase III PREGNANT (PROCHIEVE(R) Extending GestatioN A New Therapy) Study of PROCHIEVE(R) 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.

PROCHIEVE(R), CRINONE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.

Source: Business Wire

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