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MEDIA CENTER The Population Council Sells NDA Rights to NEW YORK (19 November 2003) — The Population Council announced today that it sold the New Drug Application (NDA) for ParaGard®, the Copper T 380A intrauterine copper contraceptive (ICC), to FEI for an undisclosed sum. ParaGard is safe, highly effective (99.4 percent), hormone-free, convenient, and provides long-term contraceptive protection. FEI will assume full responsibility for marketing and distributing this FDA-approved contraceptive directly to clinicians beginning 1 January 2004. Until the end of this year, clinicians can continue to order ParaGard from Ortho-McNeil Pharmaceutical, Inc. "The Copper T 380A was co-developed by the Population Council and FEI in the 1970s," said Sandra Arnold, Vice President of Corporate Affairs for the Population Council. "We are confident that FEI will work to increase awareness of this contraceptive in the medical community and among women who have never before considered using the Copper T 380A to manage their fertility." ParaGard is a reversible contraceptive with a proven track record of 20 years. ParaGard, which is placed in the uterus during a routine doctor's office visit, can be used for up to ten years or removed when a woman wants to conceive. ParaGard is proven to be as effective in preventing pregnancy as tubal ligation and is the most cost-effective method of contraception available. In fact, after two years, only abstinence is a less expensive way to prevent pregnancy. "FEI has manufactured and supplied more than 65 million Copper T 380A contraceptives for women around the world, and now we will also market ParaGard in the United States," said Fred Studier, President and CEO of FEI. "FEI will work closely with Ortho throughout 2003 to ensure a smooth transition. As a single-product company, FEI is dedicated to ParaGard and the needs of the healthcare professionals and women who rely on the product. We believe there is an enormous unmet need for long-term, reversible, hormone-free contraception in the United States. With the proper commitment, use of ParaGard in the United States should mirror the significantly higher levels in Europe and elsewhere." About ParaGard ParaGard is an effective option for women who choose not to use hormonal contraceptives, or who are considering tubal ligation. It is recommended for women who have had at least one child, are in a stable, mutually monogamous relationship, and have no history of and are not at risk for pelvic inflammatory disease (PID). Like other non-barrier methods of birth control, ParaGard does not protect against HIV/AIDS or other sexually transmitted diseases. About FEI About the Population Council Population Council Media contacts
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