Friday July 30, 9:38 am Eastern Time
Company Press Release
FDA Approves ANTAGON, The First Medication Available in the USA Indicated for Inhibiting Premature Leutenizing Hormone Surges in Women Undergoing Fertility Treatment
First Major Innovation in Ovulation Supression Regimens in More Than a Decade Cuts Days of Fertility Drug Therapy by More Than Half
WEST ORANGE, N.J.--(BUSINESS WIRE)--July 30, 1999-- Organon Inc. today announced the U.S. Food and Drug Administration's approval of ANTAGON(TM) (ganirelix acetate) Injection, indicated for inhibiting premature leutenizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. ANTAGON is the first gonadotropin-releasing-hormone (GnRH) antagonist approved for this indication in the USA.
The new treatment will help women undergoing fertility procedures significantly reduce the number of days of medication necessary to suppress LH surges (which cause ovulation) and therefore maintain eggs in the ovaries. While previously-used agonist products for hormone suppression must be taken for as many as 26 days, phase III clinical studies demonstrated that the antagonist action of ANTAGON is unique because it achieves the same goal within five days, while minimizing unpleasant side effects such as hot flashes and headaches.
Infertility affects approximately 6.1 million couples in the United States, or approximately 10 percent of the reproductive age population, according to the American Society for Reproductive Medicine.
''ANTAGON is a long-anticipated addition to infertility specialists' drug armamentarium,'' said Daniel Shapiro, M.D., a reproductive endocrinologist based in Atlanta. ''Its primary advantage is that a patient need only take it four or five days as opposed to three weeks for leuprolide,'' he said.
ANTAGON, which will be available by prescription later this year, can be self-administered by the patient via a subcutaneous injection, and clinical tests have shown that it is extremely well-tolerated.
''Organon is pleased to bring practitioners and patients another innovation in fertility treatment regimens,'' said Hans Vemer, M.D., president of Organon. ''ANTAGON represents the latest result in our unparalleled commitment to research and development of products contributing to women's health.''
Women seeking medical treatment for infertility often face a complex regimen of medications and procedures. In vitro fertilization treatment cycles have historically been initiated with the administration of leuprolide acetate to suppress the premature release of leutenizing hormones (LH), which trigger ovulation. This practice inhibits ovulation so that the eggs remain available for retrieval by a fertility specialist.
In normal ovulatory cycles, the pituitary gland would release a large pulse of LH to initiate egg ripening and release. Leuprolide must be injected daily for as many as 26 days to prevent this from occurring.
In U.S. Phase III clinical trials, patients needed to take ANTAGON for an average of just five days, compared to 22 days with leuprolide acetate.
''ANTAGON has the advantage of directly cutting off LH production, while leuprolide tricks the pituitary gland into turning off,'' said Dr. Shapiro. ''Like a light switched off, ANTAGON works immediately. Leuprolide requires that the light be turned on and left on until the bulb burns out.''
ANTAGON adds to Organon's family of products for fertility: FOLLISTIM® (follitropin beta for injection), the first recombinant follicle stimulating hormone available in the United States for stimulating the development of follicles containing eggs; PREGNYL® (chorionic gonadotropin) for ovulation induction; and now ANTAGON for ovulation suppression.
Organon Inc. of West Orange, NJ is the US affiliate of N.V. Organon, a renowned international ethical pharmaceutical company whose reproductive health products also include HUMEGON(TM) and the oral contraceptives MIRCETTE(TM) and DESOGEN®. Organon maintains a strong commitment to healthcare, conducting research in the areas of psychiatry, contraception, fertility, anesthesiology, thrombosis, immunology, osteoporosis prevention, and treatment of post-menopausal symptoms.
Organon is one of the business units of Akzo Nobel N.V. Headquartered in Arnhem, The Netherlands, Akzo Nobel serves customers throughout the world with healthcare products, coatings, chemicals, and fibers. The company employs 86,000 people in more than 70 countries, in which consolidated sales for 1998 totaled $13.8 billion. In North America alone, Akzo Nobel employs approximately 10,000 people in 125 locations, including its U.S. headquarters in Chicago. Akzo Nobel's North American sales total approximately $3 billion annually. The company's American Depository Receipts (ADRs) are traded on NASDAQ under the symbol AKZOY.
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