News
American Home Products and Aventis Pharma Reach New Agreement for Development and Marketing of Trimegestone
American Home Products Corporation (NYSE: AHP) and Aventis Pharma, the pharmaceutical company of Aventis S.A. (NYSE: AVE), announced today that they have renegotiated their licensing agreement for trimegestone, a modern progestational molecule originated by Aventis for hormone replacement therapy.
Under the new agreement, Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP, has exclusive development and worldwide marketing rights for trimegestone for all indications and formulations except transdermal products.
The rights to combination use for hormone replacement therapy (HRT) with Premarin(R) (conjugated estrogens tablets, USP) the world's leading hormone replacement product marketed by Wyeth-Ayerst for nearly 60 years, are included in the agreement. In addition, Wyeth-Ayerst will take full responsibility for development and marketing of combinations of trimegestone with 17 beta estradiol for hormone replacement therapy.
Aventis Pharma received a fee upon closing of the new agreement and will receive milestone payments for marketing authorizations obtained in major markets. Under an exclusive supply agreement, Aventis Pharma will also act as Wyeth-Ayerst's sole source for the active ingredient required for the manufacture of trimegestone through the year 2010. Further financial details are not being disclosed.
"As a world leader in hormone replacement therapies, Wyeth-Ayerst is uniquely positioned to maximize the commercial potential of trimegestone. This agreement will provide Aventis Pharma with an attractive stream of revenue from trimegestone, while at the same time allowing us to focus our resources on products in other therapeutic areas where Aventis Pharma has a strategic advantage," said Richard J. Markham, chief executive officer of Aventis Pharma.
"As the world leader in women's health care, Wyeth-Ayerst is committed to the development of new therapies," says L. Patrick Gage, Ph.D., President, Wyeth-Ayerst Research. "Our clinical development program will focus on the global development of new low-dose HRT products."
First Trimegestone Product Approved in Sweden
Regulatory authorities in Sweden recently approved the first commercial product using trimegestone, an HRT product, Totelle Sekvens. Totelle employs a cyclic regimen for hormone replacement with 14 days using 2 mg of 17 beta estradiol alone and 14 days in combination with 500 mcg of trimegestone. When Totelle Sekvens is launched by Wyeth-Ayerst in Sweden later this year it will offer women effective relief from vasomotor symptoms associated with menopause, improved and predictable cycle control, and a better lipid profile in comparison to existing products.
There can be side effects with HRT
Estrogen can increase the risk of cancer of the uterus. Progestin combined with estrogen reduces this risk. Women who have had a hysterectomy do not have this risk. Progestins may have unfavorable effects on blood sugars, which may worsen a diabetic condition. Side effects of HRT include blood clots, nausea, vomiting, irregular uterine bleeding, breast tenderness and abdominal pain.
HRT may not be right for every woman
Women should not take HRT if they had uterine cancer, abnormal vaginal bleeding, abnormal blood clotting, liver disease, heart disease or stroke. Pregnant women should not take estrogen or progestin products because of possible risk to the fetus. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular therapies, central nervous system drugs, anti-inflammatory agents, infectious disease, hemophilia, oncology, vaccines, and generic pharmaceuticals. American Home Products Corporation is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, and animal health care.
Aventis S.A. is one of the world's leading life science companies, focused on two core business areas -- pharmaceuticals and agriculture. With global corporate headquarters in Strasbourg, France, Aventis employs around 90,000 people in 120 countries and recorded pro forma sales in 1999 of euro 20.5 billion (US$ 21.1 billion). Aventis was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc S.A. Aventis Pharma AG is the pharmaceutical company of Aventis S.A. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma also encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania, USA.