Columbia Laboratories Signs U.S. License and Supply Agreement with Ascend Therapeutics to Market PROCHIEVE(R) 4% Progesterone Gel.LIVINGSTON, N.J. -- Columbia Laboratories, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CBRX) today announced that it has signed an exclusive, five year license and supply agreement with Ascend Therapeutics, Inc., for the Company's PROCHIEVE ([R]) 4% 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, currently indicated and FDA-approved for the treatment of secondary amenorrhea secondary amenorrhea n. Amenorrhea in which menstruation begins at puberty but then is subsequently suppressed. secondary amenorrhea (secondary amenorrhea is lack of periods for six or more months in a woman who has already started menstruation and who is not pregnant, lactating lac·tate 1 intr.v. lac·tat·ed, lac·tat·ing, lac·tates To secrete or produce milk. [Latin lact , or in menopause). Under terms of the agreement, effective January 1, 2008, Ascend Therapeutics will be responsible for marketing and sales of PROCHIEVE ([R]) 4% in the United States using its existing 100-person sales force that calls on a broad range of obstetricians and gynecologists (OB/GYNs). Ascend will purchase product from Columbia at a transfer price equal to 35% of its net selling price with minimum annual purchase obligations that increase over the life of the agreement. "We are pleased to announce this exclusive agreement with Ascend Therapeutics, a biopharmaceutical company with an established and growing franchise in 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. ," stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. "Ascend Therapeutics represents the perfect partner to increase sales of PROCHIEVE ([R]) 4%, given their ability to effectively reach over 14,000 physicians who are likely to prescribe progesterone but are not on our infertility target list of reproductive endocrinologists and OB/GYNs who treat infertility. With Ascend Therapeutics' efforts, we expect sales of PROCHIEVE([R]) 4% to increase significantly over the agreement term. This, in turn, will allow Columbia to maintain its renewed focus on the specialized, infertility market." "We are pleased to have the opportunity to promote a therapeutic option to treat a condition common among women. As we continue to foster and build our specialty with the OB/GYN community, PROCHIEVE ([R]) 4% will be integral to our success and will add value to our overall women's health care franchise," said Jay Bua president of Ascend. About Columbia Laboratories Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and marketing products for the women's healthcare and endocrinology markets using its novel bioadhesive drug delivery technology. Columbia markets CRINONE[R] 8% (progesterone gel) and PROCHIEVE[R] 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology Assisted reproductive technology (ART) is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used in infertility treatment, which is the only application routinely used today of treatment for infertile in·fer·tile adj. Not capable of initiating, sustaining, or supporting reproduction. infertile, adj unable to produce offspring. women with progesterone deficiency. The Company also markets STRIANT[R] (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 system) 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. The Company's research and development programs include a vaginal 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 product to prevent and treat 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. and PROCHIEVE 8% to reduce the risk of preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. birth in women with a short cervix in mid-pregnancy. For more information, please visit www.columbialabs.com. About Ascend Therapeutics Ascend Therapeutics, based in Herndon, Virginia, is affiliated with Besins Healthcare SA, a privately-held, European-based pharmaceutical company focused in women's and men's health. Pioneers in transdermal drug delivery systems, Ascend currently markets EstroGel[R] (0.06% estradiol gel), the first FDA-approved transdermal estrogen gel therapy in the United States and Besins is the originator of AndroGel[R]. For more information about Ascend, go to the company's web site at www.ascendtherapeutics.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will," "plan," "expect" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE[R] 8% (progesterone gel), PROCHIEVE[R] 8% (progesterone gel), and STRIANT[R] (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the clinical studies for our vaginal lidocaine product candidate and the planned Phase III study of PROCHIEVE 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current 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 impact of competitive products and pricing; 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. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements. |
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