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Exhibit 99.1
FOR IMMEDIATE RELEASE
CONTACT:
INVESTORS: MEDIA:
Kevin F. McLaughlin Janice M. McCourt
Senior Vice President & Vice President of Operations &
Chief Financial Officer Director of Corporate Communications
(617) 494-8400 ext. 2274 (617) 494-8400 ext. 2330
email: [email protected] email: [email protected]
PRAECIS PHARMACEUTICALS INCORPORATED
ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION
FOR PROSTATE CANCER DRUG
CAMBRIDGE, MA, DECEMBER 13, 2000. PRAECIS PHARMACEUTICALS INCORPORATED
(Nasdaq:PRCS) today announced the submission to the U.S. Food and Drug
Administration of a New Drug Application (NDA) for abarelix depot, the first in
a new class of prostate cancer drugs that avoids stimulating the secretion of
testosterone, a male hormone that causes the growth of most prostate cancers.
PRAECIS is developing abarelix depot for commercialization with Amgen Inc. in
the United States, Japan, Canada and Asia-Pacific and with Sanofi-Synthelabo in
all other global territories.
Approximately 85% of newly-diagnosed prostate cancers are hormone-dependent
tumors that require the male hormone testosterone for their continued growth.
Lowering the body's normal production of testosterone, therefore, is the primary
goal of hormonal treatment. Available hormonal therapies, however, may cause an
initial surge or increase in the level of testosterone before the desired effect
of lowering testosterone occurs. Abarelix depot is designed to rapidly block the
production of testosterone and avoid the initial testosterone level surge.
Results of two pivotal phase III safety and efficacy studies, presented in May
2000 at the annual meeting of the American Society of Clinical Oncology, showed
that zero percent of patients treated with abarelix depot experienced a
testosterone surge compared to more than 80% of patients treated with leuprolide
acetate depot, or a combination of leuprolide acetate depot plus bicalutamide,
which are the most-prescribed hormonal drug and combination of drugs. Further,
abarelix depot suppressed testosterone levels more rapidly, achieving
suppression by day 8 in approximately 70% of patients compared to zero percent
of patients treated with either leuprolide or leuprolide plus bicalutamide. Each
treatment therapy studied achieved and maintained testosterone suppression from
day 29 through day 85 in more than 90% of patients. Reported side effects, such
as hot flashes, were similar for all three hormonal treatment regimens. If
approved, abarelix depot will compete in a $2.6 billion worldwide market for
hormonal prostate cancer drugs.
"Based upon the results of the chemical studies that are included in the NDA
package, we believe that abarelix depot represents an important medical
advancement for the treatment of patients with prostate cancer," said Marc B.
Garnick, M.D., PRAECIS' Chief Medical Officer.
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"We are proud and delighted with our first product submission. PRAECIS is
working hard to make abarelix depot the first in a succession of product
submissions," said Malcolm L. Gefter, Ph.D., PRAECIS' Chairman, President and
Chief Executive Officer.
PRAECIS, together with its corporate collaborators, is also developing abarelix
depot for the treatment of endometriosis, a painful and long-lasting condition
that can be treated through the suppression of estrogen, a female hormone.
PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on the
discovery and development of pharmaceutical products using its proprietary
LEAP(TM) (Ligand Evolution to Active Pharmaceuticals) technology. LEAP combines
the power of biological selection with the advantages of medicinal chemistry in
a unique molecular evolution process. PRAECIS successfully employed LEAP in the
development of abarelix depot, its lead candidate for the treatment of prostate
cancer and endometriosis. PRAECIS also has programs in Alzheimer's disease, pain
management and AIDS.
This news release contains forward-looking statements, including, but not
limited to, statements regarding the filing of an NDA for abarelix depot, the
regulatory review of that filing by the U.S. Food and Drug Administration and
the status of the abarelix program for the treatment of endometriosis. These
statements are based on PRAECIS' current beliefs and expectations as to future
outcomes. Such statements are subject to certain factors and uncertainties that
may cause actual results to differ materially from expected results. These
include, but are not limited to, unexpected results in ongoing and future
clinical trials, the need for additional research and testing, delays in
manufacturing, access to capital and funding, and the timing and content of
decisions made by the U.S. Food and Drug Administration, as well as the risks
set forth from time to time in PRAECIS' filings with the Securities and Exchange
Commission, including but not limited to the risks discussed in PRAECIS' most
recent Form 10-Q.
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