Columbia Laboratories Reports Positive Results on Desmopressin Peptide Formulation.

Business Editors/Health & Medical Writers

NEW YORK--(BUSINESS WIRE)--Oct. 5, 2001

Columbia Laboratories (AMEX:COB) today announced that the clinical analysis of the company's initial buccal formulation of desmopressin has yielded positive results. The eight patient trial, utilizing Columbia's proprietary and patented Bio-Adhesive Delivery System (BDS) in a progressive hydration buccal tablet containing desmopressin, was designed to achieve measurable and sustainable blood levels. Data analysis confirmed detectable blood levels in the majority of patients at numerous time points over the 24-hour dosing interval.

"These results are an encouraging first step in establishing proof of concept that our proprietary delivery system can protect and sustain the delivery of desmopressin, allowing for absorption through the transmucosal membrane over an extended period of time, commented Fred Wilkinson, president and chief executive officer of Columbia Laboratories. This is a critical milestone in providing evidence that our technology may have the capability of successfully delivering small chain peptides via this route."

Based on these results, the company plans to advance the development programs for desmopressin as well as two additional peptides. Columbia will seek to optimize the formulation and progress these programs into the clinic in the fourth quarter of this year, with results anticipated before year-end. If successful, Columbia intends to develop small chain peptides that offer new and novel routes of administration.

Desmopressin is an example of a class of molecules called small chain polypeptides, which are difficult to deliver in traditional pharmaceutical formulations. The product is currently marketed by Aventis for the indications of primary nocturnal enuresis and central cranial diabetes insipidus.

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 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 achievement of positive results from subsequent desmopressin trials, timely and successful completion of clinical studies, 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.