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): July 16, 1998
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
Synaptic Pharmaceutical Corporation (the "Company"), in collaboration
with Eli Lilly and Company ("Lilly"), is currently conducting drug discovery
programs focused on a number of serotonin receptor subtypes and therapeutic
applications. One of such programs is focused on the identification and
development of compounds that are selective agonists of the serotonin 1F
receptor subtype for the treatment of migraine. Lilly recently completed a
Phase II clinical study in Europe with LY334370, a compound identified as part
of this program. This clinical study tested a wide dose range and final analysis
of the data generated in this study is in progress. An investigational new drug
request (an "IND") with respect to LY334370 was filed with the United States
Food and Drug Administration in January 1998. Lilly is conducting two additional
Phase II clinical studies with respect to LY334370 in the United States in an
effort to further define the dose response relationship and to explore
formulation options.
To date, in the limited Phase II clinical studies, LY334370 was
observed to reduce or eliminate migraine pain. According to Lilly, no
cardiovascular side effects have been observed, although at certain higher doses
side effects such as asthenia, dizziness and/or somnolence were observed. In the
ongoing Phase II clinical studies, Lilly will attempt to define the doses which
result in efficacy and compare those doses to the doses resulting in side
effects. The efficacy and side effect profile of LY334370 will then be compared
to other currently available migraine treatments. Lilly has informed the Company
that it expects to make a decision on whether to proceed to Phase III clinical
trials by the end of 1998 and that its decision will be based on the outcome of
the three Phase II clinical studies.
For a general description of Phase II and Phase III clinical trials,
see the Company's Annual Report on Form 10-K for the fiscal year ended December
31, 1997 (the "1997 Form 10-K").
This Report on Form 8-K 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, the statement relating to the timing of a decision on whether to proceed to
Phase III clinical trials and any other statements which are not historical
facts. When used in this document, the word "expect" and similar expressions are
intended to be among the words that identify forward-looking statements. Such
statements involve risks and uncertainties, including, but not limited to, those
risks and uncertainties detailed under the captions "Competition" and
"Government Regulation" in the 1997 Form 10-K, as well as the risks and
uncertainties disclosed under the captions "Early Stage of Product
Development; Technological Uncertainty," "Dependence on Collaborative Partners
and Licensees for Development, Regulatory Approvals, Manufacturing, Marketing
and Other Resources" and "Uncertainties Related to Clinical Trials" as
"Cautionary Statements" in the 1997 Form 10-K or detailed from time to time in
filings the Company makes with the Securities and Exchange Commission. Should
one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual outcomes may vary from those indicated.
Although the Company believes that the expectations reflected in the
forward-looking
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statements contained herein are reasonable, it can give no assurance that such
expectations will prove to be correct. The Company expressly disclaims any
obligation or undertaking to disseminate any updates or revisions to any
forward-looking statement contained herein to reflect any change in the
Company's expectations with regard thereto or any change in events, conditions
or circumstances on which any such statement is based.
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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: July 16, 1998
SYNAPTIC PHARMACEUTICAL CORPORATION
(Registrant)
By:/s/ Kathleen P. Mullinix
---------------------------------------------
Name: Kathleen P. Mullinix
Title: President and Chief Executive Officer
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