Columbia Laboratories Announces Regulatory Approval of Crinone for Sale in Finland.MIAMI--(BUSINESS WIRE)--Jan. 16, 1996--Columbia Laboratories Inc. (ASE (Adaptive Server Enterprise) A relational DBMS from Sybase that runs on Windows NT/2000, Linux and a variety of Unix platforms. ASE is a comprehensive and robust data management product with a long history dating back to the late 1980s. : COB) today announced it has received clearance to market Crinone(TM), its sustained release, vaginally-delivered, natural progesterone product, in Finland. The product will be marketed by Wyeth-Ayerst Laboratories, which has worldwide rights to Crinone through a licensing and supply agreement with Columbia Laboratories. Columbia is seeking approval of multiple indications for Crinone throughout Europe. These indications include the prevention of hyperplasia and endometrial cancer in postmenopausal women receiving Hormone Replacement Therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. (HRT HRT abbr. hormone replacement therapy Hormone replacement therapy (HRT) Also called estrogen replacement therapy, this controversial treatment is used to relieve the discomforts of menopause. ), for use in in vitro fertilization in vitro fertilization (vē`trō, vĭ`trō), technique for conception of a human embryo outside the mother's body. Several ova, or eggs, are removed from the mother's body and placed in special laboratory culture dishes (Petri dishes); procedures, to help reduce the symptoms of Premenstrual Syndrome (PMS (Pantone Matching System) A color matching system that has a unique number assigned to more than 500 different colors and shades. This standard for the printing industry has been built into many graphics and desktop publishing programs to ensure color accuracy. ), for menstrual irregularities, dysmenorrhea, dysfunctional uterine bleeding Dysfunctional Uterine Bleeding Definition Dysfunctional uterine bleeding is irregular, abnormal uterine bleeding that is not caused by a tumor, infection, or pregnancy. , and for infertility due to inadequate progesterone production. Complete approval by regulatory agencies for all indications has been received in Finland and the U.K. To date, Crinone has been approved for use in in vitro fertilization procedures in France, where clearance of the remaining indications is anticipated in 1996. "We are pleased to gain access to another European market and anticipate receiving regulatory clearance in several other major countries in Europe this year," said William J. Bologna, Chairman of Columbia. "Each regulatory approval and product launch represents increased revenue to Columbia. The first sales and royalty-based revenues from Wyeth-Ayerst's promotional efforts for Crinone are expected by mid-1996." Crinone utilizes Columbia's patented bioadhesive delivery system to deliver progesterone directly to the uterus, thereby maximizing therapeutic benefit and reducing side effects associated with high systemic concentrations of progesterone. Columbia Laboratories is a U.S.-based international pharmaceutical company, dedicated to the development of women's prescription and over-the-counter products, including those which help prevent sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely . Columbia's products primarily utilize the company's patented bioadhesive delivery technology. CONTACT: Margaret J. Roell Chief Financial Officer Columbia Laboratories Inc. 305/860-1692 or James W. Heins (media) Reagan Codner (investors) Burns McClellan 212/505-1919 |
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