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| |  Zeneca Receives FDA Clearance for Arimidex to Treat Breast Cancer WILMINGTON, Del., Jan. 31, 1996 -- Zeneca Inc. announced today that the Food and Drug Administration has cleared Arimidex(R) (anastrozole) tablets, a new treatment option, for advanced breast cancer in postmenopausal women whose disease has progressed following therapy with tamoxifen. The FDA made its decision after evaluating results of clinical studies involving more than 750 patients. Results from the two studies showed that Arimidex is effective in the treatment of advanced breast cancer, and causes few side effects. Most commonly reported side-effects, regardless of causality, included asthenia (fatigue), nausea, headache, hot flushes, pain and back pain. Arimidex is not associated with significant weight gain reported with progestins. In addition, Arimidex is manufactured in a tablet form for convenient once-daily dosing. Studies suggest that growth of some breast cancer tumors is stimulated by the female hormone, estrogen. Arimidex, a nonsteroidal compound, is the first entry in a new class of third-generation selective oral aromatase inhibitors. Inhibition of aromatase reduces the production of estrogen. Thus, Arimidex reduces serum concentration of estrogen, an effect that has been shown to be of benefit in postmenopausal women with breast cancer. Approximately one woman in eight will develop breast cancer in her lifetime. According to the American Cancer Society (ACS), an estimated 184,300 women will be diagnosed with breast cancer in 1996. It is estimated that about 6 percent of patients with breast cancer in the U.S. have advanced breast cancer. The U.S. market for hormonal therapies to treat breast cancer was valued at approximately $300 million in 1994. Zeneca also manufactures Nolvadex(R) (tamoxifen citrate), the most widely prescribed agent in the world for breast cancer. Since its introduction in 1978, Nolvadex has accumulated some seven million patients and years of clinical experience supporting its efficacy and safety profile. Worldwide, Nolvadex sales are approximately $500 million. "Millions of women with breast cancer have received effective therapy with our widely prescribed anticancer agent Nolvadex(R) (tamoxifen citrate). For those women whose disease eventually progresses despite this treatment, Arimidex is now available," said Paul Plourde, M.D., Senior Director of Clinical Research, Zeneca Pharmaceuticals . Recently, Zeneca received clearance for Casodex(R) (bicalutamide) for the treatment of advanced prostate cancer. Zoladex(R) (goserelin acetate implant) is currently indicated for the treatment of advanced prostate cancer and endometriosis and has recently received clearance from the FDA for use in the treatment of advanced breast cancer in premenopausal and perimenopausal women. In addition, Zeneca is investigating a new therapy for the treatment of colorectal cancer. Zeneca Pharmaceuticals currently ranks number two worldwide in its sales of anti-cancer products and intends to become the leading oncology company by the year 2000. In 1994, Zeneca Pharmaceuticals spent 25 percent of its $460 million R&D expenditure in this growing therapeutic area. In addition to Arimidex, the company will be expanding its breast cancer portfolio with other compounds. In the U.S., Zeneca Inc. is a $2.5 billion bioscience company with 6,500 employees and 45 manufacturing and research & development sites in 29 states. Zeneca Inc. is a wholly owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE: ZEN), a major $6.9 billion international bioscience business.
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