Columbia Laboratories Commences Product Launch for Prochieve 4% -Progesterone Gel-.Business Editors/Health/Medical Writers LIVINGSTON, N.J.--(BUSINESS WIRE)--March 20, 2003 Bioadhesive vaginal gel delivers natural 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. to treat secondary amenorrhea Columbia Laboratories, Inc. (AMEX AMEX See: American Stock Exchange : COB) announced today that it initiated shipments of Prochieve 4% (progesterone gel) to wholesalers & retailers on March 18. The Company's dedicated 55-person sales force will commence detailing to a targeted audience of obstetricians and gynecologists in the United States on April 1. "We are pleased to add this fourth product to our women's health care portfolio," said Fred Wilkinson, president and chief executive officer of Columbia. "Prochieve 4% is an alternative to synthetic progestin progestin /pro·ges·tin/ (-jes´tin) progestational agent. pro·ges·tin n. 1. A natural or synthetic progestational substance that mimics some or all of the actions of progesterone. that delivers natural progesterone directly to the uterus with low systemic blood levels. By marketing this product alongside Prochieve 8%, we believe our sales force can be effective in building a strong brand identity for Columbia's progesterone gel products in the OB/GYN community." Prochieve 4% is a bioadhesive vaginal gel approved for the treatment of secondary amenorrhea, a condition that affects an estimated 5.6 million women in the United States, or 4% of the general population. In women with secondary amenorrhea, menstruation begins at the appropriate age but later ceases for three or more months for reasons other than normal causes such as pregnancy, lactation lactation Production of milk by female mammals after giving birth. The milk is discharged by the mammary glands in the breasts. Hormones triggered by delivery of the placenta and by nursing stimulate milk production. or menopause. 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 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 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 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. For more information, 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 marketing of Prochieve 8%, RepHresh Vaginal Gel and Advantage-S, timely and successful development of products, timely and successful completion of clinical studies, success in obtaining acceptance and approval of new products by the 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. and international regulatory agencies, the successful launch and marketing of Prochieve 4%, 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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