Columbia Laboratories Announces Submission of New Drug Application to FDA for Testosterone Buccal Bioadhesive Product.

Business Editors/Health & Medical Writers

LIVINGSTON, N.J.--(BUSINESS WIRE)--Aug. 9, 2002

Columbia Laboratories (AMEX: COB) today announced the submission of an NDA to the U.S. Food and Drug Administration for Columbia's testosterone buccal bioadhesive product.

This submission is based on successful completion of two well-controlled clinical trials, as well as two ongoing long-term safety trials.

Columbia's testosterone buccal product is a controlled- and sustained-release bioadhesive product containing 30 mg of testosterone. It is designed to provide testosterone replacement at physiologic levels with the primary indication being hypogonadism in men. This product utilizes both the Bioadhesive Delivery System (BDS) and the hydrating buccal technology platforms previously patented by the company.

Fred Wilkinson, Columbia's president and chief executive officer stated, "We are pleased to have completed our clinical program and the other regulatory requirements that form the basis for our filing to obtain FDA approval to market this new treatment option. Our novel delivery mechanism provides an attractive treatment alternative to currently available therapies. We look forward to launching this product as early as mid 2003."

"The submission of this NDA marks another significant milestone for the company and its new management team," continued Wilkinson. "The testosterone buccal bioadhesive is the lead product in our focused research and development program. I am very proud of the operations, clinical and regulatory teams for their dedicated efforts behind this NDA package."

The company's pivotal Phase III trial in the US examined the efficacy, safety and tolerability of Columbia's testosterone buccal bioadhesive product in 98 hypogonadal men. That study showed the product's ability to deliver mean testosterone blood levels of 5.3 ng/ml (normal physiologic range is 3.0 - 10.5 ng/ml) for all patients. Eighty-five percent (85%) of patients had a mean testosterone concentration over 24 hours within the physiologic range. A low incidence of adverse events was reported with minimal local irritation, and a favorable tolerability profile. Patient and investigator preference for this new form of therapy was high.

Another trial, conducted in 67 patients in two European countries, compared Columbia's product against Andropatch, SmithKline Beecham's UK licensed testosterone replacement therapy product. Mean testosterone concentration for patients receiving Columbia's product was 5.4 ng/ml, while mean testosterone concentration for patients in the Andropatch group was 3.7 ng/ml. The mean percentage of time over the 24-hour sampling interval that testosterone concentrations were within the physiologic range was 85% for the Columbia group, and was 58% for the Andropatch group.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented Bioadhesive Delivery System (BDS) technology.

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 the company and its management team. Prospective 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. Such risks and uncertainties include, among other things, the successful marketing reintroduction of Crinone(R) by Columbia's licensee, Serono; the successful launch and marketing of Prochieve(TM), RepHresh Vaginal Gel(TM), and Advantage-S(R); the timely and successful development of products; timely and successful completion of clinical studies; success in obtaining FDA acceptance and approval of the testosterone NDA and other new products; competitive economic and regulatory factors in the pharmaceutical and healthcare industry, and 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.