-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PpZuzlJ3jAiwAL745N+2A4J0p/Fqr2ezttaAsILTYH50CD3F732/YxiMpAAjx8Zt Twdouubuc7HtcHjZm2bZIA== 0000884939-99-000003.txt : 19990308 0000884939-99-000003.hdr.sgml : 19990308 ACCESSION NUMBER: 0000884939-99-000003 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19990304 ITEM INFORMATION: FILED AS OF DATE: 19990305 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SYNAPTIC PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000884939 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 222859704 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-27324 FILM NUMBER: 99558161 BUSINESS ADDRESS: STREET 1: 215 COLLEGE RD CITY: PARAMUS STATE: NJ ZIP: 07652 BUSINESS PHONE: 2012611331 8-K 1 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 Page 1 of 5 Pages 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 Page 2 of 5 Pages 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 ---------------------------- Name: Kathleen P. Mullinix Title: Chairman, President and Chief Executive Officer Page 3 of 5 Pages 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 - Page 4 of 5 Pages 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. # # # Page 5 of 5 Pages -----END PRIVACY-ENHANCED MESSAGE-----