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): January 5, 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
Page 1 of 5 Pages
<PAGE>
Item 5. Other Events
Since December 1, 1993, Synaptic Pharmaceutical Corporation (the
"Company") has been collaborating with Merck & Co., Inc. ("Merck"), on a drug
discovery program to develop alpha 1a adrenergic antagonists for the treatment
of benign prostatic hyperplasia ("BPH"). The collaboration was due to expire on
November 30, 1998. However, the Company has agreed to provide Merck with a
minimal level of continued scientific support for an additional three-month
period. A compound identified as part of the collaboration is currently being
studied by Merck in humans for its effectiveness in treating BPH. Other
compounds selected by Merck in connection with the collaboration are undergoing
early or late preclinical testing.
On December 31, 1998, the term of the Company's collaboration with Eli
Lilly and Company ("Lilly"), which was focused on a number of serotonin receptor
subtypes and therapeutic applications, expired in accordance with the terms of
the Research, Option and License Agreement dated as of January 25, 1991. In
connection with the expiration of the collaboration, Lilly's obligation to
provide the Company with funding to support a specified number of the Company's
scientists terminated. Lilly continues to have an exclusive license under
certain patent rights and to certain technology of the Company pursuant to the
terms of the agreement and is continuing to conduct several drug discovery
programs that had been conducted as part of the collaboration. The current
status of certain of these programs is summarized in the following table:
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
__(4)(5) Depression Late Preclinical
1A Smoking Cessation Late Preclinical(6)
2C Obesity Early Preclinical
(1) The Company's technology is being utilized by Lilly in drug discovery
programs in addition to those programs referenced in the above table.
In general, the drug 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 drug 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.
Page 2 of 5 Pages
<PAGE>
"Phase II Clinical" refers to the stage following completion of the
Phase I Clinical stage at which (i) 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 or (ii) a compound which is not
necessarily a drug candidate due to certain of its pharmacological
properties nevertheless is being or has been administered to a small
sample of the actual intended patient population to seek to assess the
efficacy of the compound for the specific targeted therapeutic
indication. In the "proof of concept" case described in clause (ii),
the objective is to assess, prior to the expenditure of additional
resources, the correctness of the hypothesis that a certain receptor
subtype can be manipulated in a therapeutically beneficial manner for
the treatment of the disorder of interest.
"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 to establish further clinical safety and efficacy of
the drug candidate 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) The serotonin receptor subtype that is the focus of this program is
confidential to the Company and Lilly.
(5) The serotonin receptor subtype that is the target of this program is
different from the serotonin receptor subtype that is the target of the
depression program that is in the Phase I Clinical stage and is
different from the serotonin receptor subtype that is the target of the
other depression program that is in the Late Preclinical stage.
Accordingly, the compound that is currently the focus of this
depression program is not a back-up to either the compound that is the
focus of the depression program that is in the Phase I Clinical stage
or the compound that is the focus of the other depression program that
is in the Late Preclinical stage.
(6) During the third quarter of 1998, Lilly informed the Company that it
would not continue to develop this compound but would instead seek a
development partner or licensee for the compound that is the focus of
this program.
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
Page 3 of 5 Pages
<PAGE>
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.
Page 4 of 5 Pages
<PAGE>
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: January 5, 1999
SYNAPTIC PHARMACEUTICAL CORPORATION
(Registrant)
By:/s/ Kathleen P. Mullinix
---------------------------------
Name: Kathleen P. Mullinix
Title: Chairman, President and Chief
Executive Officer
Page 5 of 5 Pages
