Columbia Laboratories Reports Successful Completion of Formulation
Optimization for Desmopressin Buccal Tablet
Livingston, N.J. -- October 30, 2003 -- Columbia Laboratories (AMEX: COB) 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® 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.
About Columbia Laboratories
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization 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. For more information, please visit 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. 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 launch and marketing of Striant™, the impact of competitive products and pricing; success in obtaining acceptance and approval of 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. The company undertakes no obligation to publicly update any forward-looking statements.###