Columbia Laboratories Provides Corporate Update.Business Editors/Health & Medical Writers Bear Stearns The Bear Stearns Companies, Inc. (NYSE: BSC) is the parent company of Bear, Stearns & Co. Inc., one of the largest global investment banks and securities trading and brokerage firms in the world. Health Care Conference LIVINGSTON, N.J.--(BUSINESS WIRE)--Sept. 19, 2002 Columbia Laboratories (AMEX AMEX See: American Stock Exchange : COB) announced today that Fred Wilkinson, president and chief executive officer, will address the Bear Stearns Health Care Conference at 9:00 AM today, providing an update on corporate developments. Updating the Company's commercialization plan for its women's healthcare products, the 55 person sales force (provided by Innovex in a fee for service agreement) is now fully staffed. Training will be completed by September 28, and detailing to a targeted audience of obstetricians and gynecologists will commence on October 1 for Prochieve 8% (progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. gel), Advantage-S(R) bioadhesive contraceptive gel, and RepHresh Vaginal Gel(TM). Initial stocking for these products is underway, with full trade distribution to be completed during the launch period. The Company is in the process of producing batches of, and revalidating the manufacturing process for, Prochieve 4% (progesterone gel) to ensure that this product remains compliant with quality specifications and regulatory requirements. The launch and initiation of full promotional efforts behind Prochieve 4% is planned for 2003. As previously announced, the Company submitted an 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 for its 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 Testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the product to the Food and Drug Administration on August 19, 2002. Following approval, the Company plans to market the product under the trademark "Striant(TM)". The European application is in the final stage of preparation, and is scheduled for submission to the UK authorities in October 2002. An additional clinical trial comparing Striant(TM) to AndroGel(R) (testosterone gel) has been completed, and the results are expected to be published prior to the Striant(TM) launch. Columbia has been in active negotiations with parties in Europe, and anticipates completing a deal to license Striant(TM) for European markets during the fourth quarter of 2002. The Company has also completed formulation work on its lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a vaginal gel for 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. , the next product in its research and development program, and expects to complete this proof of principal trial by year-end 2002. If successful, the company plans to commence full clinical development of lidocaine during the first half of 2003. The Company's peptide development program, with desmopressin as the lead compound, continues forward on plan. The Company is engaged in active discussions with potential licensing partners for desmopressin with the intent to close out a development deal by the end of the year. One additional clinical study for desmopressin will be concluded in the fourth quarter. As previously announced, the presentation will be webcast live, then archived one hour after the presentation ends for on-demand viewing for 90 days at http://www.columbialabs.com. Columbia Laboratories, Inc. is an international pharmaceutical company dedicated to research and development of women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care and endocrinology products, including those intended to treat infertility, dysmenorrhea, 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 System (BDS BDS abbr. Bachelor of Dental Surgery BDS Bachelor of Dental Surgery BDS n abbr (= Bachelor of Dental Surgery) → título universitario BDS ) 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. 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 Prochieve(TM), RepHresh Vaginal Gel(TM) and Advantage-S(R), timely and successful development of products, timely and successful completion of clinical studies, success in obtaining FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. acceptance and approval of new products, including Striant(TM), the successful completion of a licensing deal for Striant for European markets, the successful completion of a development deal for desmopressin and competitive economic and regulatory factors in the pharmaceutical and healthcare 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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