Columbia Laboratories Announces Submission of Marketing Authorization Application to U.K. Medicines Control Agency for Striant -Testosterone Buccal Bioadhesive Product-.

Business Editors & Health/Medical Writers

LIVINGSTON, N.J.--(BUSINESS WIRE)--Dec. 3, 2002

Columbia Laboratories (AMEX: COB) today announced the submission of an application for marketing approval to the United Kingdom Medicines Control Agency for Striant(TM) (testosterone buccal bioadhesive product).

This submission is based on the NDA filed in August 2002 with the U.S. Food and Drug Administration (FDA), which the FDA accepted for review in October and for which a Prescription Drug User Fee Act date of June 19, 2003 was set. Under current regulations, approval of Striant(TM) in the U.K. is anticipated in the second half of 2003, with mutual recognition files to be submitted in all other countries within six months of this approval.

"The submission of this application in the U.K. marks another significant milestone for the company and its management team," stated Fred Wilkinson, Columbia's president and chief executive officer. "I am very proud of the operations, clinical and regulatory teams for their dedicated efforts behind this application, which begins our program for obtaining marketing approvals in Europe for Striant(TM), the lead product in our focused research and development program."

On October 16, 2002, Columbia and Ardana Bioscience, Ltd., executed a license and supply agreement for European rights to Striant(TM) in eighteen European countries (excluding Italy). In exchange for these rights, Columbia will receive $4 million in signature and milestone fees in the fourth quarter of 2002, $1 million of which was triggered by the submission of the U.K. application and $1 million of which is due on December 15, 2002. Initial regulatory approval of the U.K. application will be the basis for mutual recognition applications to be filed in the rest of Europe. Under the Ardana agreement, Columbia will receive additional milestone payments totaling $2 million upon receipt of marketing approval in major European countries. A performance payment of $2 million is also due upon achievement of a certain level of sales. Ardana will purchase its requirements of product from Columbia.

Columbia's Striant(TM) testosterone buccal bioadhesive 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.

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 acceptance and approval of the Striant(TM) NDA and other new products by FDA and international regulatory agencies; 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.