Ethyol approved for marketing by the FDA.

WEST CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Dec. 11, 1995--U.S. Bioscience, Inc. (AMEX:UBS) announced today that Ethyol(R) (amifostine, WR-2721), a selective cytoprotective agent, was cleared for marketing by the Food and Drug Administration (FDA). Ethyol is indicated to reduce the cumulative renal (kidney) toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. Ethyol represents the first of a new class of selective systemic cytoprotective agents which, when administered prior to treatment, can protect healthy cells from the damaging effects of chemotherapy.

Ethyol is expected to be available to physicians and patients in early 1996. U.S. Bioscience is currently in the advanced stage of negotiation with a potential marketing partner.

"Ethyol makes a much needed contribution to the safer use of chemotherapy and, in particular, the reduction of cumulative damage to normal organs which can limit patient tolerance to cancer treatment and reduce quality of life," said Philip S. Schein, M.D., chairman and chief executive officer, U.S. Bioscience. "We are delighted to have the FDA's clearance to market this important product."

"The approval of Ethyol is very good news for patients, and a major step forward in the treatment of cancer," said David Alberts, M.D., Professor of Medicine and Pharmacology, Deputy Director, Arizona Cancer Center, University of Arizona College of Medicine. "Often physicians must discontinue or delay therapy due to the side effects associated with chemotherapy. Ethyol represents the first approved therapy for reducing cumulative and often permanent kidney damage associated with cisplatin, one of our most important drugs for the treatment of cancer."

Chemotherapeutic agents are not selective in their effects, and can damage or destroy healthy tissue because of their relative inability to discriminate between cancer and normal cells. Importantly, repeated courses of treatment , which are ordinarily required for effective management of the tumor, carry the risk of cumulative injury to normal tissues, with a resulting diminution or loss of function.

U.S. Bioscience had previously secured a recommendation for marketing approval for Ethyol by the European Committee for Propriety Medicinal Products (CPMP) for reduction of neutropenia related risk of infection (e.g. neutropenic fever) from cyclophosphamide and cisplatin in patients with advanced ovarian cancer. U.S. Bioscience recently submitted a dossier to the CPMP requesting an expansion of the CPMP indication for Ethyol to include protection against renal toxicity resulting from repeated courses of cisplatin. Ethyol has recently been launched by Schering-Plough in a number of major European markets. Ethyol is currently under review in Canada where Eli Lilly will market the product under an alliance reached with U.S. Bioscience earlier this year.

Ethyol has a unique history representing an unanticipated benefit of the Cold War era. It originated in a previously classified United States Army nuclear warfare research project, where the drug, known as WT-2721, was selected as the best of over 4,000 chemicals tested for development as a compound which might protect soldiers from radiation exposure. Once the project became declassified, oncologists began exploring the potential role of Ethyol in medicine as a means of selectively reducing the serious toxicities associated with radiation therapy used to treat cancer patients, as well as chemotherapy.

U.S. Bioscience will continue to investigate Ethyol in other cancers utilizing different chemotherapeutic combinations as well as radiation therapy.

Based in West Conshohocken, Pennsylvania, U.S. Bioscience is a pharmaceutical company specializing in the development and commercialization of products for patients with cancer and AIDS. Ethyol represent's the Company's third NDA approval. Hexalen(R) (altretamine), a treatment for ovarian cancer and NenTrexin(R), (trimetrexate glucuronate) for the management of Pnemocystis carini pnemonia in immunocomprised patients are commercially available in the United States.

CONTACT: Robert I. Kriebel, Sr. Vice President

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