ALZA Announces Approval of Viadur For Once-Yearly Palliative Treatment of Advanced Prostate Cancer

Ц First 12-Month Dosing Regimen Provides Uninterrupted Testosterone Suppression Therapy Ц

Ц First Approved Product to Incorporate ALZAТs DUROS^о Technology Ц

MOUNTAIN VIEW, Calif., March 6, 2000 Е ALZA Corporation (NYSE: AZA) today announced that the U.S. Food and Drug Administration (FDA) has approved the companyТs new drug application (NDA) for ViadurЩ (leuprolide acetate implant), a once-yearly implant for the palliative treatment of advanced prostate cancer. ViadurЩ is the first product to provide continuous, 12-month testosterone suppression with a single treatment. It is also the first approved product to incorporate ALZAТs proprietary DUROS^о implant technology.

"We are extremely pleased with the rapid clinical development of ViadurЩ," said Samuel R. Saks, M.D., group vice president, ALZA Pharmaceuticals. "ViadurЩ is a unique product that will provide an important new therapeutic option to patients with advanced prostate cancer. We are scaling up to produce commercial quantities of this product at our new aseptic manufacturing facility."

ViadurЩ, which has been developed by ALZA on behalf of Crescendo Pharmaceuticals Corporation (Nasdaq: CNDO), is a drug-filled, miniature titanium implant that is placed under the skin in the inner aspects of a patientТs upper arm in an in-office surgical procedure. The product, which contains an osmotic engine, continuously delivers precise levels of leuprolide for a period of one full year, providing an alternative to frequent leuprolide injections. ALZA has exercised its option to obtain a worldwide license for ViadurЩ from Crescendo.

Prostate Cancer and the Role of Testosterone Suppression Therapy

Prostate cancer, the most frequently diagnosed cancer in U.S. men after skin cancer, affects an estimated one in eight American men during their lifetime. It is second only to lung cancer as the leading cause of cancer death in men. According to the American Cancer Society, in the year 2000 an estimated 180,400 new cases of prostate cancer will be diagnosed and approximately 31,900 men will die of this disease in the United States.

Testosterone suppression or hormonal therapy is commonly used for the palliative treatment of advanced stages of prostate cancer. The goal is to lower levels of the male hormone testosterone, which is associated with a therapeutic response in some patients. ViadurЩ contains the active compound leuprolide. Leuprolide is part of a class of drugs known as luteinizing hormone-releasing hormone (LHRH) agonists, which work by decreasing the amount of testosterone produced by the body. Continuous and uninterrupted testosterone suppression therapy, usually required for many months or years, is important for the palliative treatment of advanced prostate cancer.

"Leuprolide is well established as a palliative treatment for advanced prostate cancer, and the once-yearly dosing regimen provided by ViadurЩ may present a convenient alternative for patients," said James Gottesman, M.D., clinical professor of urology at the University of Washington Medical School in Seattle. "Currently, therapeutic suppression of testosterone levels is primarily achieved through intramuscular depot injections administered once every one, three or four months."

Demonstrated Efficacy and Safety of ViadurЩ

In two open-label, multicenter studies, 131 patients with advanced prostate cancer were treated with ViadurЩ and evaluated for up to two years. Following the initial surgical insertion of the implant, mean serum testosterone concentrations decreased to therapeutically desirable levels by week four in 99 percent of the patients in the study. Once serum testosterone suppression was achieved, testosterone levels remained suppressed for the duration of the 12-month treatment phase. Most patients (n=118) had a new implant inserted for a second year of therapy following removal of the first implant. No patient experienced a clinically significant increase in serum testosterone (acute-on-chronic phenomenon) upon removal of the original implant and insertion of a new implant.

Serum Prostate-Specific Antigen (PSA) was monitored as a secondary endpoint in the two clinical studies. Serum PSA concentrations decreased for patients in the studies after beginning treatment with ViadurЩ.  In clinical trials, the most common treatment-related side effects reported with ViadurЩ were those expected with LHRH agonists, including vasodilation (67.9 percent), asthenia (7.6 percent), gynecomastia (6.9 percent), depression (5.3 percent) and sweating (5.3 percent).

Local application site reactions reported by patients after insertion or removal of the implant included bruising (34.8 percent) and burning (5.6 percent). The majority of local reactions associated with initial insertion or removal and insertion of a new implant began and resolved within the first two weeks. Reactions persisted in 9.3 percent of patients. Ten percent of patients developed local reactions after the first two weeks following insertion. Like other LHRH agonists, ViadurЩ causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms, manifested by pain or bladder outlet obstruction.

Background on DUROS^о Technology

The continuous, steady-state delivery of drug by ViadurЩ results from ALZAТs unique DUROS^о implant technology, which provides an alternative for the delivery of a wide range of therapeutic compounds, including peptides, proteins and other bioactive macromolecules. ALZAТs DUROS^о implants are miniature titanium cylinders designed to provide continuous, osmotically-driven delivery of drugs within the body for up to one year. Following implantation, DUROS^о implants enable continuous, precise delivery of the therapeutic compound at rates as low as 1/100^th of a drop of water per day. The cylinder is manufactured from titanium because of the materialТs tolerability to human tissue and its long use in medical devices such as implantable defibrillators and joint replacements. The cylinder protects therapeutic agents from degradation in the body and, in conjunction with ALZAТs proprietary formulation technology, enables a drug to remain stable for extended periods of time.

ALZA Corporation, headquartered in Mountain View, Calif., is a research-based pharmaceutical company with leading drug delivery technologies. The company applies its delivery technologies to develop pharmaceutical products with enhanced therapeutic value for its own portfolio and for many of the worldТs leading pharmaceutical companies. ALZAТs sales and marketing efforts are focused in urology and oncology.

To the extent any statements made in this release deal with information that is not historical, these statements are necessarily forward-looking. As such, they are subject to the occurrence of many events outside of ALZAТs control and are subject to various risk factors that could cause ALZAТs results to differ materially from those expressed in any forward-looking statement. The risk factors are described in ALZAТs Annual Report on Form 10-K filed with the Securities and Exchange Commission and include, without limitation, the inherent risks of product marketing, product development failure, the risk of clinical outcomes, regulatory risks, and risks related to proprietary rights, market acceptance and competition.

The package insert for ViadurЩ is available upon request. For additional information about ViadurЩ, please call 1-877-4-VIADUR or visit http://www.Viadur.com.

Source: ALZA

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March 6 ,2000