Healthcare Industry News: Organon
News Release - July 18, 2006
FDA Approves IMPLANON(TM) (etonogestrel implant) 68mg, the First and Only Single-Rod Implantable ContraceptiveProvides Women and Healthcare Providers Built-In Contraceptive Confidence For Up to Three Years
ROSELAND, N.J., July 18 (HSMN NewsFeed) -- Organon announced today that the U.S. Food and Drug Administration (FDA) approved IMPLANON(TM) (etonogestrel implant) 68mg, the first and only single-rod implantable contraceptive that is effective for up to three years.
IMPLANON(TM), about the size of a matchstick, is made of a soft medical polymer and is inserted subdermally just beneath the skin on the inner side of a woman's upper arm by a healthcare provider during an in-office procedure. IMPLANON(TM) continually releases a low, steady dose of progestin (etonogestrel) for a period of up to three years via a unique, state of the art implantable technology. After insertion, IMPLANON(TM) generally is not visible, making it a discreet method of birth control. The efficacy of IMPLANON(TM) does not depend on patient self-administration. Removal can occur at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level.
"We are excited about the approval of IMPLANON(TM), which represents a real advancement in contraceptive technology and will provide women with a new level of confidence in contraception," stated Michael V. Novinski, President, Organon USA Inc. "IMPLANON(TM) further demonstrates Organon's ongoing commitment to women's reproductive health products."
IMPLANON(TM) has been used worldwide by approximately 2.5 million women in more than 30 countries since 1998. Recognizing that IMPLANON(TM) is unlike anything currently available in the U.S., Organon USA will be sponsoring a national clinical training program to train healthcare providers on the insertion and removal procedures. Only healthcare providers trained through the Organon-sponsored programs will be able to order IMPLANON(TM). The clinical training program is scheduled to begin later this year. As the training program progresses, IMPLANON(TM) will become more widely available in 2007.
"Even the best intentioned women can have difficulty using their birth control method consistently, which can lead to unintended pregnancy," said Wayne C. Shields, president and CEO of the Association of Reproductive Health Professionals. "The new contraceptive implant, IMPLANON(TM), is indicated for three years, so it can be a hopeful alternative for women who prefer not to think about birth control every day, week, or month."
For more information about IMPLANON(TM), log onto www.IMPLANON-USA.com or call 1-877-IMPLANON (1-877-467-5266).
IMPLANON(TM) does not protect against HIV infection and other sexually transmitted diseases. As with any progestin-only contraceptive, users of IMPLANON(TM) can experience irregular bleeding. Changes may include more or less frequent bleeding, bleeding for a longer or shorter duration, or absence of bleeding and may vary throughout the duration of use. Other adverse experiences include headache, acne, dysmenorrhea and emotional lability, which are side effects common to hormonal contraception.
Implant site complications were experienced by 3.6 percent of study participants and included: swelling, redness, hematoma and pain. Removal complications were also low (1.7 percent) and included: implant not palpable, broken or damaged implant, difficult localization, slight migration and formation of fibrosis. The use of hormonal contraceptives is associated with increased risks of several serious side effects, including thromboembolic diseases. Cigarette smoking increases the risk of serious cardiovascular side effects; women who use hormonal contraceptives are strongly advised not to smoke.
Organon -- with shared head offices in Roseland, NJ, USA and Oss, The Netherlands -- creates, manufactures and markets innovative 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 biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. 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.
Safe Harbor Statement*
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 www.akzonobel.com.
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