FDA approves Follistim®-AQTM cartridge - the first pre-mixed fertility treatment

FDA approves Follistim®-AQTM cartridge - the first pre-mixed fertility treatment Arnhem, the Netherlands, March 24, 2004 - The U.S. Food and Drug Administration (FDA) today announced approval of Follistim®-AQTM cartridge (follitropin beta injection) in the United States. Follistim-AQ cartridge is the first follicle stimulating hormone (FSH) treatment available in a pre-filled, pre-mixed solution, eliminating the need for patients to mix one or more vials of medication. Follistim-AQ cartridge is designed to be used only with the Follistim® PenTM, an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication. Follistim is prescribed for women undergoing assisted reproductive treatments (ART) such as in vitro fertilization (IVF), and for the induction of ovulation to achieve pregnancy. Follistim-AQ cartridge, used with the Follistim Pen, provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. Organon USA Inc. markets Follistim-AQ cartridge and Follistim Pen. In Europe it is marketed under the brand name Puregon® PenTM. "Fertility treatment can be of concern for patients, in large part because they have to mix, measure and inject the medicine themselves," said Samuel Pang, MD, Associate Medical Director, reproductive Science Center of Boston, and an investigator in the Follistim-AQ cartridge/Follistim Pen clinical trials. "This innovative method of delivering FSH makes the process go much more smoothly, because the medicine is already mixed and the patient just has to dial the correct dose. Also, the micro needle and small volume of medication may contribute to patient tolerability of the injection." Organon is pleased that the FDA has approved Follistim-AQ cartridge for patients experiencing infertility," said Michael Novinski, President, Organon Pharmaceuticals USA Inc. "The introduction of Follistim-AQ cartridge, enhances Organon's position as a leader in the development, production and marketing of innovative, patient friendly fertility treatment." Results of clinical studies have shown that self-injection with Follistim-AQ cartridge, for use with Follistim Pen, is safe, convenient and well tolerated by patients. According to a recent study conducted by Samuel Pang, MD et al.1, the lead author for the Follistim Pen COH Study Group, of the 60 women who participated in the study 59 (98.3%) rated the overall experience of self-injecting with the Follistim Pen as "very good" to "good." Infertility affects about six million American couples, approximately 10 percent of the reproductive age population. The U.S. Centers for Disease Control reported there were nearly 110,000 cycles of assisted reproductive technology in the year 2001. 1 Pang, S. et al. "An open-label, non-controlled multi-center study to evaluate subject comprehension, ease of use, safety and efficacy of the Follistim PenTM for the self-administration of Follistim® AQ Cartridge during Controlled Ovarian Hyperstimulatoin (COH) in subjects scheduled for IVF and ICSI." Organon, Inc. Note for the editor Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2003 totaled EUR 13 billion. The Company currently employs approximately 64,500 people in more than 80 countries. Financial results for the first quarter will be published on April 20, 2004. Organon, headquartered in Roseland, NJ, USA creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel. Internet: www.akzonobel.com; www.organon.usa.com; www.follistim.com (for complete prescribing information). Not for publication - for more information Akzo Nobel N.V. John de Munnik, Manager Corporate Communications, tel. +31 26 366 4343 Organon Pharmaceuticals UCA Inc. Fran DeSena, Senior Director of Communications and Media Relations, tel. +1 973 325 5353 Safe Harbor Statement* This press release may contain statements which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. 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