ALZA Announces Approval of Viadur For Once-Yearly
Palliative Treatment of Advanced Prostate Cancer
– First 12-Month Dosing Regimen Provides Uninterrupted
Testosterone Suppression Therapy –
– First Approved Product to Incorporate ALZA’s DUROS®
Technology –
MOUNTAIN VIEW, Calif., March 6, 2000 … ALZA Corporation (NYSE: AZA) today
announced that the U.S. Food and Drug Administration (FDA) has approved the
company’s new drug application (NDA) for Viadur™ (leuprolide acetate implant), a
once-yearly implant for the palliative treatment of advanced prostate cancer.
Viadur™ is the first product to provide continuous, 12-month testosterone
suppression with a single treatment. It is also the first approved product to
incorporate ALZA’s proprietary DUROS® implant technology.
"We are extremely pleased with the rapid clinical development of Viadur™,"
said Samuel R. Saks, M.D., group vice president, ALZA Pharmaceuticals. "Viadur™
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."
Viadur™, 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 patient’s 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 Viadur™ 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. Viadur™ 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 Viadur™ 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 Viadur™
In two open-label, multicenter studies, 131 patients with advanced prostate
cancer were treated with Viadur™ 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 Viadur™. In clinical trials,
the most common treatment-related side effects reported with Viadur™ 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, Viadur™ 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® Technology
The continuous, steady-state delivery of drug by Viadur™ results from ALZA’s
unique DUROS® implant technology, which provides an alternative for
the delivery of a wide range of therapeutic compounds, including peptides,
proteins and other bioactive macromolecules. ALZA’s DUROS® 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® implants enable continuous, precise
delivery of the therapeutic compound at rates as low as 1/100th of a
drop of water per day. The cylinder is manufactured from titanium because of the
material’s 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 ALZA’s
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 world’s
leading pharmaceutical companies. ALZA’s 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 ALZA’s control and are subject to various risk factors that
could cause ALZA’s results to differ materially from those expressed in any
forward-looking statement. The risk factors are described in ALZA’s 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 Viadur™ is available upon request. For additional
information about Viadur™, please call 1-877-4-VIADUR or visit
http://www.Viadur.com.
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