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FOR IMMEDIATE RELEASE
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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]
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PRAECIS PHARMACEUTICALS INCORPORATED
HIGHLIGHTS NEW THERAPEUTIC PROGRAMS AT THE
JP MORGAN H&Q 19TH ANNUAL HEALTHCARE CONFERENCE
CAMBRIDGE, MA, January 11, 2001. PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq:
PRCS) presented a company overview today at the JP Morgan H&Q 19th Annual
Healthcare Conference in San Francisco. The presentation was webcast live and
will be available for replay for a period of one week on PRAECIS' website at
www.praecis.com under "Investor Relations."
PRAECIS discussed its compounds in clinical development for the treatment of
prostate cancer, endometriosis, pain management and Alzheimer's disease. The
Company confirmed the submission to the U.S. Food and Drug Administration (FDA)
of a New Drug Application (NDA) for abarelix depot, the first in a new class of
prostate cancer drugs called GnRH antagonists. Abarelix depot avoids stimulating
the secretion of testosterone, a male hormone that causes the growth of most
prostate cancers, and causes a rapid reduction of testosterone. The Company also
presented an update on its clinical studies of abarelix depot for the treatment
of endometriosis and stated that it expects the next pivotal endometriosis
clinical study to begin during the first quarter of 2001.
The Company announced the initiation in January 2001 of a phase II study of
Latranal, its proprietary topical composition for the treatment of localized
muscle, tendon or neuropathic pain. The Company intends to enroll 300 patients
suffering from lower back pain in this randomized, placebo controlled study and
expects to have interim results of the study during the third quarter of 2001.
The Company also reviewed the results of recent preclinical studies of Apan, the
Company's drug candidate in development for the treatment of Alzheimer's
disease. The hallmark of Alzheimer's disease is the accumulation of plaque-like
deposits in the brain that are composed largely of a peptide called
beta-amyloid. A large body of clinical, biochemical and genetic evidence has led
to the theory that when beta-amyloid molecules aggregate they become toxic to
nerve cells, and that this toxicity leads to the development and progression of
Alzheimer's disease. Preclincal experiments have shown that Apan specifically
inhibits the aggregation of beta-amyloid and its associated nerve cell toxicity.
Alzheimer's disease, and the associated accumulation of beta-amyloid in the
brain, is often thought of as a defect in the ability to clear beta-amyloid from
the brain into the
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cerebral spinal fluid (CSF). Both humans and transgenic mice with Alzheimer's
disease plaques show increased levels of beta-amyloid in the brain and decreased
levels in the CSF. Transgenic mice treated with Apan show significant increases
in beta-amyloid levels in the CSF, suggesting that Apan is able to mobilize
beta-amyloid in the brain and facilitate its clearance.
Commenting on these results, John H. Growdon, M.D., a Professor of Neurology at
Harvard Medical School and a Director of the Alzheimer's Disease Research Center
at the Massachusetts General Hospital stated, "The significant increase in
beta-amyloid levels in the CSF of the transgenic mice treated with Apan suggests
that this compound could alter the course of Alzheimer's disease by a novel
mechanism."
The Company confirmed the submission to the FDA in December 2000 of an
Investigational New Drug Application (IND) for Apan and its expectation of
initiating a phase I clinical trial during the first quarter of 2001.
In addition, the Company gave an overview of its product pipeline, and
disclosed that, in addition to its four compounds in clinical development, it
currently has seven compounds in preclinical development. The Company briefly
discussed several of its preclinical research programs. Those highlighted
included a program in inflammatory disease therapeutics targeting NF-kB, a
central mediator of inflammation, and a program in HIV therapeutics targeting
CCR5, the molecular entry point for the AIDS virus. The Company also provided
a brief overview of its Rel-Ease-TM- technology, which has been used to
produce abarelix and other compounds in sustained release formulations. The
Company discussed its plans to use its Rel-Ease technology to create
sustained release formulations of approved drugs, as well as potential
products discovered using its proprietary LEAP-TM-technology.
The Company stated that its goal is to file two IND's in 2001 and estimated that
within seven years the total combined market opportunity of its product pipeline
could be in excess of $7.0 billion.
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 PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING, BUT NOT
LIMITED TO, STATEMENTS REGARDING THE FILING OF AN NDA FOR ABARELIX DEPOT, THE
INITIATION OF ADDITIONAL ENDOMETRIOSIS CLINICAL STUDIES, THE CONTINUATION OF
CLINICAL STUDIES OF LATRANAL AND THE EXPECTED PROGRESS OF THOSE STUDIES, THE
RESULTS OF PRELIMINARY APAN PRECLINICAL STUDIES, THE
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FILING OF AN IND FOR APAN AND THE INITIATION OF APAN CLINICAL STUDIES, THE
STATUS OF CERTAIN PRECLINICAL STUDIES OF NF-KB AND CCR5, AND PRAECIS' PLANS
FOR USE OF ITS REL-EASE-TM-TECHNOLOGY. 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 PRECLINICAL TESTING OR 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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