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 10, 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 September 10, 1999, Synaptic Pharmaceutical Corporation (the
"Company") issued a press release announcing that its corporate partner Merck &
Co., Inc. ("Merck") has discontinued commercial development of the benign
prostatic hyperplasia compound identified as part of the Company's collaboration
with Merck. 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. Page
- ----------- ----
99 Press Release dated September 10, 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: September 14, 1999
SYNAPTIC PHARMACEUTICAL CORPORATION
(Registrant)
By:/s/ Kathleen P. Mullinix
----------------------------------------
Name: Kathleen P. Mullinix
Title: Chairman, President and
Chief Executive Officer
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Exhibit No. 99
--------------
FOR IMMEDIATE RELEASE Contact: Kathleen P. Mullinix, Ph.D.
Chairman, President and
Chief Executive Officer
Synaptic Pharmaceutical Corporation
(201) 261-1331, ext. 103
Robert D. Ferris
Ruder Finn, Inc.
(212) 715-1573
SYNAPTIC PHARMACEUTICAL BPH PROGRAM UPDATE
PARAMUS, N.J., September 10, 1999 - Synaptic Pharmaceutical Corporation (Nasdaq:
SNAP) has been informed by Merck & Co., Inc. that data from a Phase IIa clinical
trial conducted by Merck has indicated that its alpha adrenergic drug
development candidate for the oral treatment of benign prostatic hyperplasia
(BPH) increased urine flow acutely in humans with less apparent potential to
cause the cardiovascular side effects associated with other alpha adrenergic
drugs currently on the market. However, due to limited oral bioavailability and
the potential for drug interactions, Merck has advised Synaptic that it is
discontinuing oral development efforts.
The clinical trials conducted by Merck served to validate one of the
Company's proprietary G protein-coupled receptors as a target for drug
discovery. These trials confirmed the Company's discovery that, of the three
alpha adrenergic receptors, the alpha 1-a receptor is an appropriate target for
BPH. Further, the trials provide some support for the hypothesis that the
cardiovascular side effects associated with BPH drugs on the market that work
through the alpha adrenergic system, but that do not selectively target the
alpha 1-a receptor over other alpha adrenergic receptors, may be caused by their
lack of selectivity for the adrenergic 1-a receptor.
The Company holds several U.S. patents covering the use of alpha 1-a
antagonists having defined degrees of selectivity for the alpha 1-a receptor
relative to one or both of the other alpha-1 receptors for the treatment of BPH.
In addition, the Company holds U.S. patents covering the use of genetically
engineered cells expressing the human alpha 1-a receptor to identify compounds
that bind to the receptor, as well as U.S. patents covering the genes encoding
the three human alpha adrenergic receptors. Pursuant to its agreement with the
Company, Merck has a license under these patents to develop and commercialize
alpha 1-a antagonists. Merck has indicated that it is attempting to identify
additional compounds to replace the former lead compound.
"While Merck's discontinuance of oral development is obviously very
disappointing to us and our shareholders," said Kathleen P. Mullinix, chairman,
president and chief executive officer of the
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Company, "we, like most people in this business, recognize that drug development
is an extremely difficult process, with the vast majority of compounds failing
at an early stage. At the same time, we are gratified that Merck was able to
demonstrate in clinical trials that the alpha 1-a adrenergic mechanism
discovered by Synaptic has validity, specifically shown by increasing urine flow
in patients with BPH. For us, these clinical data further demonstrate the value
of our human receptor technology in providing new targets for drug discovery to
the pharmaceutical industry."
Synaptic Pharmaceutical Corporation is a leading company in the
discovery and validation of G protein-coupled receptor targets for drug
discovery. The Company's technology, "human receptor-targeted drug design
technology," involves the use of cloned human receptors that the Company
validates as targets for the design of potential drugs. Licensees of the
Company's patented technology are Eli Lilly and Company, Merck and Co., Inc.,
Novartis Pharma A.G., and Grunenthal GmbH. The Company is currently
collaborating with Grunenthal to validate certain G protein-coupled receptors as
targets for discovery of drugs for the treatment of pain.
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 any statements relating to the
future of the Company's and Merck's drug discovery program, any statements
relating to the value of the Company's technology and patent estate and any
other 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, the inability to identify
additional drug development candidates or potential products, the inability to
license from third parties drug candidates, 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
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, 1998 (the "1998 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 1998 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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