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| |  Ethyol Now Available Nationwide PALO ALTO, Calif. April 18, 1996 -- ALZA Corporation (NYSE: AZA) and U.S. Bioscience, Inc. (AMEX: UBS) today announced the availability of Ethyol(R) (amifostine), a unique new agent that helps reduce the cumulative kidney toxicity associated with repeated administration of the chemotherapy drug cisplatin in advanced ovarian cancer or non-small cell lung cancer (NSCLC). Cisplatin-based therapy is one of the most common and effective chemotherapy regimens used in the treatment of advanced ovarian cancer and NSCLC. Recent advances in this type of chemotherapy for the treatment of advanced ovarian cancer have improved survival rates in these patients. Unfortunately, cumulative kidney toxicity associated with cisplatin is severe and is a major dose-limiting toxicity of cisplatin-based therapy. This toxicity becomes more prolonged and severe with repeated courses of therapy. Before another course of cisplatin can be given, kidney function must return to normal. "In the advanced ovarian cancer trial, significantly fewer patients pretreated with Ethyol(R) had a protracted elevation in serum creatinine (a measure of kidney function) after cisplatin treatment serious enough to cause delay or discontinuation of further cisplatin," said Samuel R. Saks, M.D., ALZA Corporation's Senior Vice President of Medical Affairs. Use of Ethyol(R) in Advanced Ovarian Cancer or NSCLC In the United States, ovarian cancer and NSCLC are two of the most common and difficult to treat solid tumors, with NSCLC the number one cause of cancer death. Ovarian cancer ranks second in incidence among gynecologic cancers and causes more deaths than any other cancer of the female reproductive system. In a clinical trial of patients with advanced ovarian cancer who received cisplatin-based chemotherapy, 30 percent of those who did not receive Ethyol(R) lost kidney function equivalent to the loss of one kidney. This was reduced to 13 percent in patients who received Ethyol(R). In this trial, Ethyol(R) had no detectable effect on the antitumor efficacy of cisplatin-based chemotherapy. In a Phase II, single-arm study of 25 patients with Stage IV NSCLC receiving high-dose cisplatin-based therapy, the data demonstrated that Ethyol(R) reduced cumulative kidney toxicity. The 64 percent partial tumor response and the 17-month median survival rate observed in this trial suggest that the effectiveness of this cisplatin-based regimen was not altered by Ethyol(R). These data are being confirmed in a randomized Phase III study. In clinical trials, the most common side effects were nausea and vomiting. Antiemetic medication is recommended to help ameliorate these effects. Transient reductions in blood pressure were frequently seen during Ethyol(R) infusions; therefore, patients who are hypotensive, dehydrated or on antihypertensive therapy that cannot be interrupted should not receive Ethyol(R). Ethyol(R)'s indication is currently limited to patients with advanced ovarian cancer or NSCLC because there are at present only limited data on the impact of Ethyol(R) on chemotherapeutic efficacy in other settings. Additional trials are underway to evaluate Ethyol(R)'s protective effects with other chemotherapy drugs and radiotherapy regimens used in various tumor types. Availability of Ethyol(R) Under terms of a marketing and sales distribution agreement entered into in December 1995, ALZA Corporation has exclusive rights to market Ethyol(R) in the United States for five years, with an option to extend for an additional year, and will be responsible for sales and marketing. ALZA Corporation and U.S. Bioscience will promote Ethyol(R) to oncologists and oncology health care providers, further enhancing their presence in the oncology field. Ethyol(R) has recently been launched by an affiliate of Schering-Plough Corporation in a number of major European markets, including France, Germany and the United Kingdom. The product is currently under regulatory review in Canada and, under an agreement with U.S. Bioscience, will be marketed by Eli Lilly. U.S. Bioscience, based in West Conshohocken, Pa., is a pharmaceutical company specializing in the development and commercialization of products for patients with cancer and AIDS. Ethyol(R) represents the company's third product achieving FDA clearance for marketing. ALZA Corporation, headquartered in Palo Alto, Calif., is a leader in the development and commercialization of innovative pharmaceutical products using advanced drug delivery technologies to add medical and economic value to drug therapies.
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