-----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, AfBrYlMbC+VxDIZaIQ7xFcABOfAIi7dRV8MYD20Ceql+My8WXm0AlPifVL/ywuQm FgKdXA7632xnDHEjba8Uaw== 0001047469-98-029473.txt : 19980806 0001047469-98-029473.hdr.sgml : 19980806 ACCESSION NUMBER: 0001047469-98-029473 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19980731 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980805 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: COCENSYS INC CENTRAL INDEX KEY: 0000895034 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330538836 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20954 FILM NUMBER: 98677929 BUSINESS ADDRESS: STREET 1: 201 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497536100 MAIL ADDRESS: STREET 1: 201 TECHNOLOGY DRIVE STREET 2: 201 TECHNOLOGY DRIVE CITY: IRVINE STATE: CA ZIP: 92618 8-K 1 FORM 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 31, 1998 ------------- COCENSYS, INC. -------------- (Exact Name of Registrant as Specified in Charter) DELAWARE 0-20954 33-0538836 - -------- ------- ---------- (State or Other (Commission (IRS Employer Jurisdiction of File Number) Identification No.) Incorporation) 201 TECHNOLOGY DRIVE, IRVINE, CALIFORNIA 92618 - ---------------------------------------- ----- (Address of Principal Executive Office) (Zip Code) Registrant's telephone number, including area code: (949) 753-6100 -------------- PAGE 1 OF 4 EXHIBIT INDEX BEGINS ON PAGE 2 ITEM 5. OTHER EVENTS. Attached hereto as Exhibit 99.1 is a copy of a Press Release issued on behalf of the Registrant announcing that G.D. Searle & Co. has decided not to participate further in the development of Registrant's proprietary compounds for treatment of insomnia. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (a) Not applicable. (b) Not applicable. (c) EXHIBITS. The following exhibits are attached to this Current Report on Form 8-K: Sequential Exhibit Description Page Start ------- ----------- --------- 99.1 Press Release entitled "CoCensys and Searle End 3 Collaboration on Development of Insomnia Treatment" dated July 31, 1998 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. COCENSYS, INC. (Registrant) Date: August 3, 1998 By: /s/ Peter E. Jansen -------------------------------------- Peter E. Jansen, Vice President and Chief Financial Officer PAGE 2 OF 4 EX-99.1 2 EXHIBIT 99.1 Contact: F. Richard Nichol, Ph.D. Marcia Kean or President & Chief Executive Officer Lucy Morrison COCENSYS, INC. FEINSTEIN KEAN PARTNERS 949/753-6100 617/577-8110 Joann L. Data, M.D., Ph.D. Executive Vice President, Product Development and Regulatory Affairs COCENSYS, INC. 949/753-6100 COCENSYS AND SEARLE END COLLABORATION ON DEVELOPMENT OF INSOMNIA TREATMENT COCENSYS CONTINUES TO FOCUS ON GANAXOLONE, LEAD PRODUCT FOR MIGRAINE IRVINE, California/PR Newswire/July 31, 1998 - CoCensys, Inc. (Nasdaq: COCN) announced today that G.D. Searle & Co., a wholly-owed subsidiary of Monsanto Company, has decided not to participate further in the development of CoCensys' proprietary compounds for treatment of insomnia. CoCensys retains all of its rights to the compounds in this program. CoCensys intends to continue research and development of its compounds to treat insomnia and will consider seeking a new partner for the program in the future. "CoCensys has studied CCD 3693, our lead compound for insomnia, in a limited series of human trials designed to assess the safety of the compound. No serious adverse events have been reported, and the data from this series of trials has provided valuable information regarding the neuro-pharmacological activity of this compound," said F. Richard Nichol, Ph.D., President and Chief Executive Officer of CoCensys. "With the information that we have obtained through our collaboration with Searle, we are well positioned to move forward with this program," Dr. Nichol added. CCD 3693 and the back-up compounds are synthetic versions of naturally occurring neuroactive compounds known as epalons that bind to the GABAA receptors in the brain. "CCD 3693 is one of the initial epalons developed by CoCensys. In the Phase I studies of this compound, we found no cardiovascular or other adverse side effects, and high doses were extremely well-tolerated. We are encouraged by the safety profile that continues to emerge on epalons," said Joann L. Data, M.D., Ph.D., CoCensys' Executive Vice President, Product Development and Regulatory Affairs. PAGE 3 OF 4 COCENSYS AND SEARLE END COLLABORATION ON DEVELOPMENT OF INSOMNIA TREATMENT July 31, 1998 Page Two "CoCensys continues to have strong confidence in epalons, based on the emerging clinical profile, and we are adhering to our core strategy of expediting the development of ganaxolone for migraine. We started a second Phase II clinical trial of ganaxolone for migraine and both enrollment in the trial and dosing are progressing rapidly," Dr. Nichol added. "We remain clearly focused on our mission of advancing the development of epalon-based therapeutics for neurological and psychiatric disorders." CoCensys is a biopharmaceutical company that discovers and develops products to treat neurological and psychiatric disorders. The Company's product development programs focus on novel small molecule compounds for the treatment of migraine, epilepsy, anxiety, insomnia, stroke, Parkinson's, neurodegenerative diseases and neuropathic pain. More information about the Company is available on its web site: http://www.cocensys.com. This press release includes forward looking statements that involve a high degree of technological, regulatory and competitive risks and uncertainties inherent to early stage biopharmaceutical companies. Actual results may differ due to a number of factors, including the fact that preclinical testing and clinical trial results are not necessarily predictive of whether future testing and trials will replicate or confirm these results or whether a therapeutic agent will succeed in subsequent clinical trials or be approved by the FDA or other regulatory agency as a drug, as well as those factors that are more fully discussed in the Company's most recent Form 10-K and Form 10-Q. - ### - PAGE 4 OF 4 -----END PRIVACY-ENHANCED MESSAGE-----