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): September 21, 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. The current status of certain of these programs is summarized in
the following table:
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Program(1) Receptor(s) Primary Indication(s) Status(2)
- --------------------------------------------------------------------------------
Serotonin 1F Acute Migraine Phase II Clinical(3)
__(4) Depression Phase I Clinical
__(4)(5) Depression Late Preclinical
1A Smoking Cessation Late Preclinical(6)
2C Obesity Early Preclinical
- --------------------------------------------------------------------------------
(1) The Company is working with Lilly on receptor and drug discovery
programs in addition to those programs referenced in the above table.
In general, the drug discovery and receptor discovery programs that are
specifically referenced in the above table are at more advanced stages
of development than those that are not specifically referenced in the
table.
(2) "Early Preclinical" refers to the stage at which one or more leads have
been identified and are being tested in in vitro or in vivo model
systems for one or more indications. In addition, at this stage lead
compounds may have been shown to be active in animal models for one or
more indications and preliminary toxicology and pharmacokinetics
studies will also have been concluded.
"Late Preclinical" refers to the stage preceding the Phase I Clinical
stage at which a clinical candidate has been selected, scale-up of such
candidate is underway or completed, and toxicology and pharmacokinetics
studies are planned or underway or have been concluded.
"Phase I Clinical" refers to the stage preceding the Phase II Clinical
stage at which a drug candidate is being or has been administered to a
small group of healthy human subjects for the purpose of testing for
safety (adverse effects), dose tolerance, absorption, bio-distribution,
metabolism, excretion and clinical pharmacology.
"Phase II Clinical" refers to the stage at which a drug candidate is
being or has been administered to a small sample of the actual intended
patient population to seek to assess the efficacy of the drug candidate
for the specific targeted indication, to determine dose tolerance and
the optimal dose range and to gather additional information relating to
safety and potential adverse effects.
"Phase III Clinical" refers to the stage at which a drug candidate is
being or has been administered to a broader sample of the general
patient population at geographically dispersed study sites to establish
further clinical safety and efficacy of the drug candidates in order to
determine its overall risk-benefit ratio and to provide an adequate
basis for all physician labeling.
(3) In August 1998, the Company and Lilly announced that this compound
would advance to the Phase III Clinical stage.
(4) This information is confidential to the Company and Lilly.
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(5) The receptor subtype that is the target of this program is different
from the receptor subtype that is the target of the depression program
that is in the Phase I Clinical stage.
(6) The Company reported in its Form 10-Q for the quarter ended March 31,
1998, that Lilly had selected a compound in this smoking cessation
program for possible development and that the compound was undergoing
late preclinical testing. However, Lilly recently informed the Company
that, as a result of competing priorities, it would not continue to
develop this compound and would instead seek a licensee or development
partner for the compound.
- --------------------------------------------------------------------------------
The Company reported in its Form 10-Q for the quarter ended June 30,
1998, that, with respect to the drug discovery program focused on the
identification and development of serotonin 2B antagonists for the prophylactic
treatment of migraine, Lilly had determined, based upon competing priorities, to
discontinue development of the compound that was undergoing late preclinical
testing and to seek a licensee or development partner for the compound. Since
this report, however, Lilly has informed the Company that, due to its analysis
of additional data with respect to the compound, Lilly had determined to
terminate the program entirely and will no longer seek a licensee or development
partner for the compound.
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 any statements which
are not historical facts. 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 drug candidates, any unexpected adverse side effects or
inadequate therapeutic efficacy of drug candidates that could slow or prevent
product development efforts, competition within anticipated product markets, the
uncertainty of product development in the pharmaceutical industry, the inability
to license potential products or certain rights thereto to third parties, the
uncertainty of patent protection for intellectual property or trade secrets and
those risks and uncertainties detailed under the captions "Competition" and
"Government Regulation" in the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 1997 (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. Although
the Company believes that the expectations reflected in the forward-looking
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: September 21, 1998
SYNAPTIC PHARMACEUTICAL CORPORATION
(Registrant)
By: /s/ Kathleen P. Mullinix
-------------------------------
Name: Kathleen P. Mullinix
Title: Chairman, President and
Chief Executive Officer
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