Columbia Laboratories Reports Positive Results of Pregnancy Rate Pilot Study with Prochieve-R- 8%.

LIVINGSTON, N.J. -- Use of Prochieve 8% and Estradiol with Clomiphene Citrate More Than Doubled Pregnancy Rates versus Clomiphene Citrate Alone

Columbia Laboratories, Inc. (NASDAQ:CBRX) announced positive results of an 88-patient randomized, open-label pilot study evaluating the efficacy, safety and tolerability of Prochieve(R) 8% (progesterone gel) and oral estradiol hormone supplementation in conjunction with clomiphene citrate on conception rates in timed intercourse cycles.

Of the 71 evaluable patients, 34 women were treated with clomiphene citrate followed by oral estradiol and Prochieve 8% (CEP Regimen), while 37 received clomiphene citrate alone. Cycle one data demonstrated a clinically meaningful trend for pregnancy rates in the CEP Regimen arm, which were more than double the control arm. This single-center pilot study was stopped before full enrollment so that the data could be assessed and a multi-center trial could be designed.

"The pregnancy rates achieved in this study demonstrate the benefits of using a sequential estrogen and progesterone supplementation regimen with Prochieve 8% for clomiphene citrate cycles in oligo-ovulatory and anovulatory women," stated Karen E. Elkind-Hirsch, MSc, PhD, scientific director of research, Woman's Health Research Institute, Woman's Hospital, Baton Rouge, LA and the lead investigator of this study. "Though the data did not achieve statistical significance, these clinically significant pilot data showing a higher pregnancy rate with the CEP Regimen extend the findings from our prior biopsy study, in which the CEP Regimen corrected the endometrial abnormalities seen in clomiphene citrate cycles."

Fred Wilkinson, Chairman, President and Chief Executive Officer of Columbia Laboratories, said, "Our patented progesterone gel has been used by OB/GYNs and fertility specialists to help infertile women safely and effectively achieve and sustain pregnancy in the first trimester since its market introduction in 1997. We are very pleased with the clinically meaningful outcome demonstrated in this pilot study, a doubling of pregnancy rates with Prochieve 8%. We look forward to presenting full results of this study at appropriate scientific forums and to further evaluating the CEP Regimen in a larger, multi-center study."

This study enrolled 88 women, 21 to 35 years of age, whose confirmed anovulatory and oligo-ovulatory condition would typically lead to fertility treatments. All patients were treated with 100 mg clomiphene citrate orally for Days 3 to 7 of the cycle. Starting on Day 8, patients in the CEP Regimen arm also received 3 mg oral estradiol twice daily until detection of a surge in luteinizing hormone (LH) levels. Intercourse was encouraged starting on Day 10. Three days after the LH surge, patients in the CEP Regimen arm began treatment with Prochieve(R) 8 % (progesterone gel); daily use of Prochieve 8 % continued for two weeks, followed by a pregnancy test. If pregnant, all patients in the CEP Regimen arm received Prochieve 8% for an additional 10 weeks.

About Prochieve 8%

Prochieve 8% (progesterone gel) is a bioadhesive product that is approved by the U.S. Food and Drug Administration (FDA) for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.

Prochieve 8% utilizes Columbia Laboratories' proprietary Bioadhesive Delivery System to deliver progesterone vaginally in a convenient and easy-to-use pre-filled, tampon-like applicator. Using a non-immunogenic (hypo-allergenic) bioadhesive polymer designed to adhere to the vaginal tissue, Prochieve 8% promotes controlled and sustained absorption of progesterone and minimizes leakage, a side effect commonly seen with vaginal suppositories. As a result, the product does not restrict normal activities. Prochieve 8% contains 90 mg of natural progesterone. It is FDA approved and safe for use during pregnancy.

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.

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies. Columbia markets Striant(R) (testosterone buccal system) for treatment of hypogonadism in men, Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and Prochieve(R) 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company has developed a buccal delivery system for peptides. Columbia's products primarily utilize the company's Bioadhesive Delivery System (BDS) technology. For more information, please visit www.columbialabs.com.

This press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of Columbia Laboratories and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: the acceptance of study results for presentation or publication by relevant scientific journals or forums; the market acceptance of Prochieve 8%; challenges and costs inherent in product marketing; competitive economic and regulatory factors in the pharmaceutical and health care 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. Investors should read this press release with the understanding that actual future results may be materially different from what the Company expects. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, Columbia undertakes no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Striant(R) and Prochieve(R) are registered trademarks of Columbia Laboratories, Inc.