<PAGE>
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 INVESTIGATIONAL NEW DRUG
APPLICATION FOR ALZHEIMER'S DISEASE DRUG
CAMBRIDGE, MA, DECEMBER 29, 2000. PRAECIS PHARMACEUTICALS INCORPORATED
(Nasdaq:PRCS) today announced the submission to the U.S. Food and Drug
Administration (FDA) of an Investigational New Drug application (IND) to
initiate Phase I clinical trials of Apan, its drug candidate in development for
the treatment of Alzheimer's disease.
Alzheimer's disease affects an estimated four million people in the United
States and is expected to become increasingly prevalent as the population ages.
Current therapies provide temporary relief for some of the symptoms of
Alzheimer's disease, but do not affect the progression of the disease itself.
The hallmark of Alzheimer's disease is the accumulation of plaque-like deposits
in brain tissue. A major component of this plaque is a small peptide called
beta-amyloid. A large body of clinical, biochemical and genetic evidence
suggests that when beta-amyloid molecules aggregate they become toxic to nerve
cells, which leads to the development and progression of Alzheimer's disease.
Preclinical experiments have shown that Apan inhibits the aggregation of
beta-amyloid and its associated nerve cell toxicity. In addition, Apan reaches
the brain in animals in quantities that the Company believes are sufficient to
block the aggregation of beta-amyloid molecules and alter the course of the
disease.
Accumulation of beta-amyloid in the brain is often thought of as a defect in the
ability to clear beta-amyloid from the brain through the 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, indicating that Apan is able to mobilize beta-amyloid in the
brain and may be facilitating its clearance.
<PAGE>
PRAECIS expects to begin a normal volunteer, Phase I clinical trial of Apan
during the first quarter of 2001, contingent upon any additional requests from
the FDA prior to the commencement of trials. The principal purpose of a Phase I
trial is to determine safety of a drug in human subjects.
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 IND for Apan, the regulatory
review of that filing by the U.S. Food and Drug Administration and potential
commencement of clinical trials of Apan. 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.
# # #
