RPR RECEIVES FIRST APPROVAL FOR NEW COMBINATION PATCH ESTALISÔ
Clearance marks new option in the treatment of menopause
Collegeville, PA, and Antony, France, March 6, 1998 -- Rhône-Poulenc Rorer (RPR), the global pharmaceutical subsidiary of Rhône-Poulenc S.A. (NYSE: RP), announced today that it received its first global marketing clearance for a new combination patch EstalisÔ /EstalisÔ Sekvens (sequential in Swedish) in Sweden for hormone replacement therapy in patients with symptoms of estrogen deficiency and for the prevention of postmenopausal osteoporosis in women with an increased risk of osteoporosis. This new combination patch, manufactured by Noven Pharmaceuticals, Inc. (NASDAQ:NOVN), will provide women with the convenience of estrogen and progestogen in one patch.
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 43 million women in the menopausal age range (50-59) in Europe and 16 million in the US.
The Estalis patch, designed to be comfortable, cosmetically appealing and easy to use, incorporates innovative matrix technology in which the adhesive also functions as the drug delivery system. "At RPR we recognize that, with today’s busy lifestyles, women need a simple and convenient way to take both estrogen and progestogen," said Dr. Gary T. Shearman, Senior Vice
President, Pharmaceutical Drug Development at Rhône-Poulenc Rorer. "Our new combination matrix patch regimens can offer healthcare providers a new hormone-replacement option to satisfy the needs of millions of women in the menopausal age range."
Hormone replacement therapy is a very personal decision and not all women want or need the same treatment regimen. In response, Estalis has been developed to provide a choice of regimen: the Estalis patch alone - a continuous combination of 50 mcg of estrogen (17-beta estradiol) and 250 mcg of progestogen (norethisterone acetate NETA) per day - or Estalis Sekvens - a sequential 28 day regimen consisting of 50 mcg/day of estrogen for 14 days and estrogen and progestogen combined (50/250mcg/day) for the remaining 14 days.
In phase II and III clinical studies involving more than 2,500 post-menopausal women, Estalis/Estalis Sekvens regimens were well tolerated and resulted in rapid relief of vasomotor symptoms, adequate endometrial protection and excellent skin adhesivity. The most significant side effects linked to the treatment were breast pain, dysmenorrhea and application site reactions.
In 1997, RPR submitted a New Drug Application (NDA) for both the continuous combined and sequential regimens of the combination patch to the U.S. Food and Drug Administration (FDA) seeking approval to market the product for the relief of moderate-to-severe vasomotor symptoms (e.g., hot flashes, night sweats) associated with menopause.
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.
Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. Rhône-Poulenc S.A. (NYSE: RP) is a leading life sciences company, growing through innovations in human, plant and animal health and through its specialty chemicals subsidiary, Rhodia. With sales in 1997 of FF90 billion (US$15 billion), the company employs 68,000 people in 160 countries worldwide.