ROSELAND, N.J., Aug. 24 /PRNewswire/ -- Today Organon USA announces the availability of a 900 IU presentation of Follistim(R) AQ Cartridge (follitropin beta injection) for use with the Follistim Pen(R), a pen injection device allowing accurate, fine-tune dosing of fertility medication in 25 IU increments for patients undergoing assisted reproductive technology procedures, such as IVF. Now physicians have more flexibility in prescribing and patients have more flexibility in self-administering this convenient and easy-to-use formulation of Follistim(R) AQ Cartridge. Unlike other follicle stimulating hormone (FSH) products on the market, the Follistim(R) AQ Cartridge does not require mixing and is delivered through a unique fine-needle, pen injection device.
Follistim(R) AQ Cartridge, also available in 300 and 600 IU presentations, is the leading recombinant FSH administered via a pen injection device in the United States.(1)
“Typically, women over the age of 35 require a higher dose of FSH treatment than if they were undergoing treatment in their twenties or early thirties, due to the continuous decline in egg supply that naturally occurs as all women age.” said Steven Spandorfer, M.D., a reproductive endocrinologist at the Center for Reproductive Medicine and Infertility New York-Presbyterian Hospital/Weill Cornell Medical Center.
“As an industry leader dedicated to improving women’s healthcare and the development of innovative fertility treatment, Organon is pleased to offer physicians a full spectrum of FSH dosing that helps them to more easily tailor a treatment regimen to meet each patient’s individual needs,” said Michael Novinski, President, Organon USA Inc. “Through our brands and supporting web sites, Organon is committed to providing integrated programs that meet patient’s needs.”
Organon continues to support patients and physicians in the fertility community with innovative products and educational resources. Patients can log on to http://www.fertilityjourney.com, an online resource that provides information, guidance and support as they undergo fertility treatments. Topics include: testing and diagnosis, therapy options and coping techniques. An online clinic locator assists with finding a local IVF clinic. Visitors to the site can also register to receive a free monthly e-newsletter and can order guidebooks packed with full-color diagrams, charts and support information.
Safety Information
Follistim(R) AQ Cartridge administered with Follistim Pen(R) delivers on average an 18% higher amount of follitropin beta compared to lyophilized preparations administered with a conventional syringe and needle. The difference is due to the accurate dosing obtained with the Follistim Pen(R) compared to a conventional syringe and needle. Like all gonadotropins, Follistim(R) AQ Cartridge is a potent substance capable of causing mild to severe side effects including ovarian hyperstimulation syndrome (OHSS), with or without pulmonary or vascular complications. Treatment with Follistim(R) AQ Cartridge may result in multiple gestations. Follistim(R) AQ Cartridge should be prescribed only by physicians who are experienced in infertility treatment and should advise their patients of treatment risks, including OHSS and multiple births. Please refer to the package insert for a complete list of side effects.
About Organon
Organon, with shared head offices in Roseland, NJ, USA and Oss, The Netherlands creates, manufactures 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 remain or become 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. For more information about Organon, please go to http://www.organon-usa.com .
This report contains statements which address such key issues as Organon’s growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements, including but not limited to the “Outlook,” 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. These factors also include changes in regulations or interpretations related to the implementation and reporting under IFRS, decisions to apply a different option of presentation permitted by IFRS, and various other factors related to the implementation of IFRS, including the implementation of IAS 32 and 39 for financial instruments. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies.
For a more complete discussion of the risk factors affecting our business please see the Akzo Nobel Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Company’s website http://www.akzonobel.com. * Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
(1) Based on total number of IUs sold from July 2004-June 2005, IMS --
National Sales Perspectives, June 2005
Organon USA
CONTACT: Fran DeSena of Organon USA Inc., +1-973-325-4500; or Tracy Nadenof Fleishman Hillard Inc. for Organon USA, +1-212-453-2460
