FDA Approves Organon's IMPLANON(TM) (Etonogestrel Implant) 68Mg, The First And Only Single-Rod Implantable Contraceptive

ROSELAND, N.J., July 18 /PRNewswire/ -- 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.

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* Pursuant to the U.S. Private Securities Litigation Reform Act 1995. Contact: Frances DeSena Kasey Pickett Organon USA Inc. Fleishman-Hillard Inc. 973-325-4500 212-453-2486

CONTACT: Frances DeSena of Organon USA, +1-973-325-4500; or Kasey Pickettof Fleishman-Hillard Inc., +1-212-453-2486, for Organon USA

Web site: http://www.IMPLANON-USA.com/