SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): March 4, 1999
SYNAPTIC PHARMACEUTICAL CORPORATION
(Exact Name of Registrant as Specified in Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
0-27324 22-285-9704
(Commission File Number) (I.R.S. Employer Identification No.)
215 College Road
Paramus, New Jersey 07652-1431
(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: (201) 261-1331
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Item 5. Other Events.
On March 4, 1999, Synaptic Pharmaceutical Corporation (the "Company")
issued a press release announcing that its corporate partner Eli Lilly and
Company ("Lilly") has delayed the beginning of the Phase III clinical trials of
the migraine compound identified as part of the Company's collaboration with
Lilly. A copy of the press release is attached as Exhibit 99 to this Form 8-K
and incorporated by reference herein.
Item 7. Exhibits.
Exhibit No. Description Page
- ----------- ---------------------------------- ----
99 Press Release dated March 4, 1999 4
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date: March 5, 1999
SYNAPTIC PHARMACEUTICAL CORPORATION
(Registrant)
By: /s/Kathleen P. Mullinix
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Name: Kathleen P. Mullinix
Title: Chairman, President and
Chief Executive Officer
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EXHIBIT 99
----------
FOR IMMEDIATE RELEASE
Contact: Kathleen P. Mullinix, Ph.D.
Chairman, President and
Chief Executive Officer
Synaptic Pharmaceutical Corporation
(201) 261-1331, ext. 103
Stacy Lipschitz
Ruder Finn, Inc.
(212) 583-2757
SYNAPTIC PHARMACEUTICAL MIGRAINE PROGRAM UPDATE
PARAMUS, N.J., March 4, 1999 - Synaptic Pharmaceutical Corporation (Nasdaq:
SNAP) has been informed by Eli Lilly and Company that Lilly has temporarily
delayed the beginning of Phase III clinical trials of the migraine compound
(LY334370) identified as part of Synaptic's collaboration with Lilly. The reason
for the delay, according to Lilly, is to enable Lilly to collect additional
information that will help assess the safety and tolerability of the compound.
Lilly is considering revisions to the clinical study protocols based on
discussions with the FDA since the week of February 18, 1999. The Phase III
clinical trials had been scheduled to commence in March.
Migraine headache is a condition that involves periodic throbbing headaches
often accompanied by nausea and vomiting. It is believed that the prevalence of
migraine in the general population may be as high as 10 percent. Loss in work
productivity provides an economic reason for improved therapies in this
underserved market. The market for migraine therapies is estimated to be about
$1.2 billion today and could grow to approximately $3 billion by the year 2000
because awareness of existing therapies will increase as new drugs enter the
marketplace.
LY334370 is a selective serotonin 1F agonist (SSOFRA), which represents a new
class of potential treatments for migraine headache. Data from three Phase II
clinical trials conducted by Lilly indicated that the compound is efficacious in
the treatment of migraine without the cardiovascular side effects associated
with other treatments currently on the market.
Synaptic Pharmaceutical Corporation has developed "human receptor-targeted drug
design technology," in which cloned human receptors are used as targets for the
design of potential drugs. The company is engaged in collaborations with two
pharmaceutical companies in addition to Lilly.
- more -
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This press release contains "forward looking statements" within the meaning of
Section 27A of the Securities Act of 1933, and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited to,
statements that are not historical facts, including those relating to the
migraine clinical trials. Such statements involve risks and uncertainties,
including, but not limited to, those risks and uncertainties relating to
difficulties or delays in development, testing, regulatory approval, production
and marketing of the companies' drug candidates, any unexpected adverse side
effects or inadequate therapeutic efficacy of the companies' drug candidates
that could slow or prevent product development efforts, competition within the
companies' anticipated product markets, the uncertainty of product development
in the pharmaceutical industry, the uncertainty of patent protection for the
companies' intellectual property or trade secrets and other risks detailed from
time to time in filings Synaptic makes with the Securities and Exchange
Commission, including its annual report on Form 10-K and its quarterly reports
on Forms 10-Q. Such statements are based on management's current expectations,
but actual results may differ materially due to various factors, including those
risks and uncertainties mentioned or referred to in this press release.
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