Columbia Laboratories' Striant New Drug Applicaton Accepted for Filing by FDA.

Business Editors/Health & Medical Writers

LIVINGSTON, N.J.--(BUSINESS WIRE)--Oct. 21, 2002

Columbia Laboratories (AMEX: COB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for its Striant(TM) (testosterone) Buccal Bioadhesive product, and that June 19, 2003 has been set as the goal date to review and act on the NDA under the Prescription Drug User Fee Act.

The Company is seeking approval to manufacture and market Striant(TM) for the treatment of hypogonadism in men. It is estimated that hypogonadism affects as many as 4 million men in the U.S., of which only approximately one million men are currently treated.

"We are pleased to announce that our Striant(TM) NDA has been accepted by the FDA for active review," said Fred Wilkinson, president and chief executive officer of Columbia. "The agency's filing of this NDA marks another important milestone for the Company and its management team. While acceptance for filing of an NDA does not assure approval, we believe our clinical data are strong. If granted final FDA approval, we expect that Striant(TM) will provide an important and convenient therapeutic alternative for patients."

The clinical data supporting the Striant(TM) NDA were generated from two well-controlled clinical trials, a U.S. pivotal trial that evaluated Striant(TM) in 98 hypogonadal men and a multi-center 67-patient trial conducted in two European countries that compared Striant(TM) to Andropatch(TM), GlaxoSmithKline's testosterone replacement therapy product. Two long-term safety trials are ongoing.

Striant(TM) is a controlled- and sustained- release bioadhesive tablet containing 30mg of testosterone. The novel tablet, which is 9mm in diameter and adheres to the patient's gum, allows the slow release and absorption of testosterone through gum and cheek surfaces that are in contact with the tablet. This product utilizes both the Bioadhesive Delivery System (BDS) and the hydrating buccal technology platforms previously patented by the company.

Columbia Laboratories, Inc. is an 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. 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, timely and successful completion of clinical studies, success in obtaining regulatory acceptance and approval of new products, including Striant, 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.