Columbia Laboratories' Announces the Commencement of Phase III Trials for Its Testosterone Progressive Hydration Buccal Tablet -PHBT- for Men.

Business Editors/Health & Medical Writers

NEW YORK--(BUSINESS WIRE)--Nov. 21, 2000

-European Phase III trials expected to be completed

by the end of Q1 2001-

Columbia Laboratories (AMEX:COB) today announced that its testosterone progressive hydration buccal tablet (PHBT) for men will commence Phase III trials in Europe within one week. The 10 center, 5 country, European Phase III trial is expected to be completed by April 2001. A second Phase III trial is planned to begin in 9 centers in the United States in January. The company believes that it will be able to submit its registration filing in Europe early in the 3rd quarter and an NDA in the USA in the 4th quarter of 2001.

The European Phase III trial will compare Columbia's PHBT testosterone with existing transdermal patches. A complete hormone profile will be evaluated including total testosterone, free testosterone and dehydrotestosterone (DHT) levels. Our earlier trials demonstrated that with the Columbia buccal technology we could induce a more favorable testosterone to DHT ratio than is traditionally seen with transdermal patches. The company hopes to document this important advantage in its Phase III trials in Europe. In the US, a three-month trial will begin in January with the objective of confirming that Columbia's buccal testosterone can maintain physiologic levels in men 24 hours a day.

Preliminary data from the Phase II trial in the UK demonstrated that hypogonadal men can be maintained within the normal therapeutic range for the entire dosing interval. The men indicated that they preferred the PHBT to their previous therapy and have agreed to remain in the study indefinitely so that we can gain needed long-term experience.

"The data generated to date confirms that we are meeting our objectives of producing physiologic testosterone levels throughout the day" said William J. Bologna, Chairman and CEO.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care 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 technology.

This press release contains statements which 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 favorable outcome of clinical trials, 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.