Clinical Pregnancy Rates Comparable in Older Women Undergoing IVF-ET, Using Three Different Progesterone Preparations; Once Daily Vaginal Gel May Improve Compliance

Retrospective analysis compares efficacy of three different formulations of progesterone in women over 35 undergoing IVF-ET.

LIVINGSTON, NJ AND ATLANTA, GA, OCTOBER 20, 2009 – A retrospective analysis, conducted at a large infertility clinic between January 2003 and December 2008, demonstrated that there were no significant differences in pregnancy outcomes with three different progesterone formulations for women aged 35 to 40 undergoing in vitro fertilization-embryo transfer (IVF-ET) procedures. These data were presented at the American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta.

The study, conducted at Boston IVF, compared the efficacy of luteal supplementation with a once daily dosing of vaginal progesterone gel (CRINONE® 8%), a progesterone capsule formulation administered three times daily and intramuscular progesterone given once daily. In all cases, progesterone was started the day following egg retrieval.

In a podium presentation, Brian M. Berger, MD, Boston IVF, Harvard Medical School, reported that all progesterone formulations achieved comparable clinical outcomes. Ongoing pregnancy rates were similar between once daily vaginal progesterone gel (44.2%), progesterone capsule administered three times daily (44.9%) and intramuscular injection given once daily (39.6%).

“Our objective was to compare pregnancy outcomes between three progesterone regimens used for luteal phase support, in a more challenging patient population,” said Dr. Berger. “We clearly showed that all three formulations have similar efficacy. However, we can also conclude that once daily dosing with CRINONE is more convenient and less invasive for patients and, therefore may lead to a better patient experience and compliance.”

This study was supported by a grant from Columbia Laboratories, Inc. (Nasdaq: CBRX)

About Progesterone and Luteal Phase Support

Progesterone is a hormone naturally found in a woman’s body, which creates a healthy environment in the uterus, where a fertilized egg can implant and grow into a healthy pregnancy. Most women undergoing infertility treatment need additional progesterone, to help prepare the uterus for implantation and development of a fertilized egg.

Before ovulation, progesterone levels in a woman’s body remain relatively low, but rise after ovulation, during the luteal phase. The luteal phase is the latter part of a woman’s menstrual cycle. It begins with the production of progesterone and ends with either pregnancy or menstruation, when the uterus sheds its lining. During pregnancy, progesterone helps to maintain the lining of the uterus, providing necessary nutrients to support and nurture a fertilized egg.

About CRINONE^® 8%

CRINONE was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE 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 include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 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.

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 (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, 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 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 may contain 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 and STRIANT in the U.S.; the successful marketing of CRINONE by Merck Serono; the timely and successful development of PROCHIEVE 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 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.

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