Columbia Laboratories Announces Issuance of Patent Covering Bioadhesive Progressive Hydration Tablet.Business Editors & Medical Writers NEW YORK--(BUSINESS WIRE)--June 27, 2001 Columbia Laboratories Inc. (AMEX AMEX See: American Stock Exchange :COB) announced today that it has been issued United States patent number 6,248,358, covering its bioadhesive, bioerodible progressive hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. tablets for the sustained and controlled release of therapeutic compounds. Columbia is presently applying this delivery platform to its testosterone buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal tablets for the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. in men as well as the peptide projects currently under active development. The patent specifically covers the technology that affords protection of an active therapeutic agent from premature degradation caused by metabolism, moisture, enzymes or pH effects, while providing bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. at a sustained and controlled rate. Due to the bioadhesive aspect of the technology, tablet formulations are able to remain on absorptive surfaces, such as the vaginal and buccal cavities, for extended periods of time. The combination of these two processes, progressive hydration and bioadhesion, allows for unique administration of these formulations. Fred Wilkinson, Columbia Laboratories' president and chief executive officer commented, "The issuance of this patent supports the value of our unique bioadhesive delivery system (BDS BDS abbr. Bachelor of Dental Surgery BDS Bachelor of Dental Surgery BDS n abbr (= Bachelor of Dental Surgery) → título universitario BDS ) technology and strengthens our development initiatives to enhance those products which use BDS as their foundation. Testosterone Buccal tablet is the most advanced project based on this proprietary hydration technology and potentially offers an important advancement for patients who could benefit from the availability of a buccal delivery option. As the Phase III trials near completion in the US and Europe, we are on track to file the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any in the first quarter of 2002." 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 dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. , endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. , 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, successful outcomes 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. |
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