LIVINGSTON, N.J.--Feb. 5, 2008--Columbia Laboratories, Inc. has received Institutional Review Board (IRB) approval for the first of 19 planned clinical sites for the Company’s Phase III PREGNANT (PROCHIEVE(R) Extending GestatioN A New Therapy) study. This randomized, double-blind, placebo-controlled clinical trial will evaluate the effect of PROCHIEVE(R) 8% on reducing the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo.
“This approval enables us to start recruiting patients in this important clinical study and thus meet our stated goal of beginning patient enrollment during the first quarter of 2008,” stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. “Seventeen of the nineteen clinical sites in the PREGNANT short cervix study participated in our prior preterm trial, and were very effective at recruiting patients in that study. We fully expect to complete this study within one year, and believe we are well positioned to fund this study using our current resources.”
Most of the remaining study sites have filed with their IRBs and Columbia anticipates receiving most of the other IRB approvals within the next 30 to 60 days.
About Short Cervix
Women who have a cervical length of 3.0 centimeters or less when measured by transvaginal ultrasound in mid-pregnancy are at increased risk for preterm birth. It is estimated that 10% and 30% of pregnant women have a cervical length of less than 2.5 and 3.0 centimeters, respectively, when measured in mid-pregnancy.
About PROCHIEVE 8%
PROCHIEVE 8% (progesterone gel) is FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used by tens of thousands of women globally to help sustain pregnancy at the early stages for ten years.
The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.
For more information, please visit www.prochieve8.com.
About Columbia Laboratories
Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and marketing products for the women’s healthcare and endocrinology markets using 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) to treat hypogonadism in men. The Company’s research and development programs include a vaginal lidocaine product to prevent and treat dysmenorrhea and PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy. 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 short cervix clinical research program, which statements are indicated by the words “will,” “plan,” “believe,” “expect,” and similar expressions. Such forward-looking statements are subject to 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 following: 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 completion of clinical studies, including the Phase III study of PROCHIEVE 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.
CRINONE(R), PROCHIEVE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.
CONTACT: Columbia Laboratories, Inc. James A. Meer, 973-486-8860 Senior Vice President, CFO & Treasurer or Investors and Media: Rx Communications, LLC Melody A. Carey, 917-322-2571 Co-President
