COB Columbia Laboratories

Columbia Laboratories Reports Successful Completion of Formulation Optimization for Desmopressin Buccal Tablet LIVINGSTON, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Columbia Laboratories today announced that it has completed the formulation optimization phase for the development of desmopressin in a buccal tablet. The Company further announced that they will now re-initiate an aggressive business development project to conclude an agreement with the appropriate development and commercial partner for this project. Final analyses of clinical pharmacokinetic trials conducted on numerous buccal formulations at different dosages again showed the ability to deliver desmopressin through the buccal mucosa and to achieve therapeutic blood levels in approximately ninety-two percent (92%) of all subjects treated. The most recent formulations met the pattern for delivery originally defined for the project which includes the ability to sustain the delivery of the active product for 8 to 12 hours. "The conclusion of this phase of development of desmopressin is an important milestone within our peptide development program," commented Fred Wilkinson, Columbia's president and chief executive officer. "With these final results, we intend to license this product to a partner for both development and commercialization. We will now focus our attention and resources on development of at least two other peptides used to treat female disorders and endocrine diseases." Desmopressin is currently marketed in the United States by Aventis Pharmaceuticals, Inc., under its registered trademark DDAVP(R) and is indicated for the management of primary nocturnal enuresis, as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. 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 has introduced Striant(TM) (testosterone buccal system) for treatment of hypogonadism in men. Columbia's products primarily utilize the Company's patented Bioadhesive Delivery System (BDS) technology. For more information, please visit http://www.columbialabs.com/. 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, the timely and successful development of buccal formulations of desmopressin, positive results from subsequent desmopressin trials, timely and successful completion of clinical studies, timely and successful partnering negotiations, 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. DATASOURCE: Columbia Laboratories, Inc. CONTACT: Jim Apostolakis, Vice Chairman, +1-212-588-1900, or David Weinberg, Chief Financial Officer, +1-973-994-3999, both of Columbia Laboratories; or Investors, Ritu Baral of The Trout Group, +1-212-477-9007, ext. 25, for Columbia Laboratories Web site: http://www.columbialabs.com/

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