Data From Meta-Analysis Show Clinical Pregnancy Rate With Vaginal Progesterone is Comparable With Intramuscular Progesterone When Administered at Optimal Dosing in Infertility Patients

LIVINGSTON, N.J.--(BUSINESS WIRE)--Columbia Laboratories, Inc. (Nasdaq:CBRX) announced today that the full report of a meta-analysis evaluating vaginally-administered progesterone versus intramuscular (IM) progesterone injections in infertility patients is available online. CRINONE® 8% was the vaginal treatment used in five out of the seven studies analyzed. Key findings of the meta-analysis show that the clinical pregnancy rate with vaginal progesterone is comparable with IM progesterone when administered at optimal dosing, and that vaginal progesterone is associated with a significantly lower rate of miscarriage than IM progesterone. The meta-analysis was initially published as an abstract and presented at the American Society of Reproductive Medicine (ASRM) annual meeting in 2007. The study was accepted for publication in Fertility and Sterility, the official journal of ASRM.

The meta-analysis was conducted by Paul W. Zarutskie, M.D., of the Zarutskie Fertility and Endocrine Institute, Seattle, Washington. The study includes data from previously conducted randomized clinical trials meeting acceptance criteria combined with recent research results. The main outcome measures of the study were clinical pregnancy, ongoing pregnancy and miscarriage rates in women undergoing progesterone treatment as part of an assisted reproductive technology regimen.

“This analysis adds to a growing body of clinical research that provides the data necessary to change the paradigm of luteal phase support for assisted reproductive technology from IM to vaginally administered progesterone,” said Dr. Zarutskie.

Robert S. Mills, president and chief executive officer of Columbia Laboratories, stated, “We are very pleased with these results, which support and magnify the outcomes of previous clinical trials of CRINONE® 8% demonstrating its benefits versus IM progesterone in helping women undergoing infertility treatments to achieve and sustain a viable pregnancy.”

The meta-analysis abstract can be accessed via the following link: http://www.ncbi.nlm.nih.gov/pubmed/19362303?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum.

About CRINONE® 8%

CRINONE® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE® 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed. For more information, please visit www.crinoneusa.com.

The most common side effects of CRINONE® 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE® 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.

CRINONE® is a registered trademark of Columbia Laboratories, Inc.

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® 8% (progesterone gel) in the United States for progesterone supplementation as part of an ART treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company’s partners market CRINONE® 8%, STRIANT®, and three other products to additional U.S. and foreign markets. The Company is conducting, in collaboration with the NIH, the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix at 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 strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will," "plan," "expect" 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 following: the successful marketing of CRINONE® 8% (progesterone gel) and STRIANT® (testosterone buccal system) in the U.S.; the successful marketing of CRINONE® 8% by Merck Serono, and RepHresh® and Replens® by Lil’ Drug Store Products, Inc; the timely and successful development of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) 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; our ability to obtain financing in order to fund our operations and repay our debt as it comes due; the impact of competitive products and pricing; the strength of the U.S. dollar relative to international currencies, particularly the Euro; 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 update any forward-looking statements.