Wyeth-Ayerst Laboratories NDA for New Indication for Alesse Accepted by FDA.

Business Editors/Health & Medical Writers

ST. DAVIDS, Pa.--(BUSINESS WIRE)--Jan. 18, 2001

Two Clinical Trials Evaluated Leading 20 Microgram Oral

Contraceptive, Alesse, For the Treatment of Moderate Acne

Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE:AHP), announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the Company's New Drug Application (NDA).

The submission seeks market approval for Alesse(R) (0.1 mg levonorgestrel/20 mcg ethinyl estradiol tablets) to treat moderate acne vulgaris in women of reproductive age with no known contraindications to oral contraceptive (OC) therapy, who desire contraception, and are unresponsive to topical anti-acne medications.

Filing acceptance means FDA will review the NDA. Possible review outcomes are "approved," "approvable," (FDA decides more information is necessary) or "not approved." FDA must act on the indication within 10 to 12 months of its submission. If this new indication is approved, Alesse would be the first oral contraceptive containing 20 micrograms of estrogen indicated for the treatment of acne.

"Acne is the most common skin disorder affecting adolescents and young adults," says Dr. Philip de Vane, Vice President, Clinical Affairs and North American Medical Director for Wyeth-Ayerst.

Alesse is a low-dose monophasic oral contraceptive approved in 1997 by the FDA for the prevention of pregnancy and is the leading 20 microgram oral contraceptive in the U.S. market. Like all combination birth control pills, Alesse is 99 percent effective in preventing pregnancy when used as directed.

Oral contraceptives are not for every woman. Most side effects of the Pill are not serious. Those that are occur infrequently. Serious risks of all birth control pills that can be life threatening include blood clots, stroke, and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35. Women who use oral contraceptives should not smoke. Some women should not use the Pill, including women who have had heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding, and those who are or may be pregnant. The Pill does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease 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 also is a global leader in vaccines, biotechnology, and animal health care.

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products, and patent, and other risks and uncertainties, including those detailed from time to time in AHP's periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements.