RPR SUBMITS APPLICATIONS FOR COMBINATION HORMONE-REPLACEMENT THERAPY PATCH
Collegeville, Pa., and Antony, France, August 11, 1997 -- Rhône-Poulenc Rorer Inc. (NYSE: RPR) today announced that it has submitted new drug applications to regulatory authorities in the U.S. and the European Union for a combination estrogen/progestogen patch.
In the U.S. the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the relief of moderate-to-severe vasomotor symptoms (e.g., hot flashes, night sweats) associated with menopause. The Marketing Authorization Application (MAA) submitted in Europe seeks approval for prevention of post-menopausal osteoporosis as well as relief of vasomotor symptoms.
The new patch will provide the convenience of estrogen and progestogen in one patch for women who have not had a hysterectomy. The patch is designed to be comfortable, cosmetically appealing and easy to use, incorporating innovative matrix technology in which the adhesive also functions as the drug delivery system. The applications are based on the results of six multicenter, randomized studies of over 2,500 non-hysterectomized post-menopausal women.
"At RPR we recognize that, with today’s busy lifestyles, women need a simple and convenient way to take both estrogen and progestogen," said Gary Shearman, Senior Vice President, Pharmaceutical Drug Development at Rhône-Poulenc Rorer. "Our new combination matrix patch has the potential to offer healthcare providers a new hormone-replacement option to satisfy the needs of millions of women in the menopausal age range."
Menopause normally occurs in women around the age of 50, when blood estrogen levels decrease, causing hot flashes, night sweats, vaginal dryness and other symptoms. By the year 2000, there will be approximately 80 million women in the menopausal age range in the U.S. and Europe.
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN), an industry leader in the development and commercialization of transdermal and transoral drug delivery systems, will manufacture Rhône-Poulenc Rorer’s combination patch and is the innovator of the product’s matrix technology.
Rhône-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to improving human health. In 1996, the Company had sales of $5.4 billion and invested $882 million in research and development.
Contacts:
Doug Arbesfeld
610-454-5889Bob Pearson
610-454-3872Karen Scott
33-1-55-71-76-22