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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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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): OCTOBER 16, 1998
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COCENSYS, INC.
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(Exact Name of Registrant as Specified in Charter)
DELAWARE 0-20954 33-0538836
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(State or Other (Commission (IRS Employer
Jurisdiction of File Number) Identification No.)
Incorporation)
201 TECHNOLOGY DRIVE, IRVINE, CALIFORNIA 92618
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(Address of Principal Executive Office) (Zip Code)
Registrant's telephone number, including area code: (949) 753-6100
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ITEM 5. OTHER EVENTS.
Attached hereto as Exhibit 99.1 is a copy of a Press Release issued on behalf of
the Registrant announcing clinical results from the Registrant's Phase II trial
of ganaxolone for acute migraine.
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:
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Sequential
Exhibit Description Page Start
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99.1 Press Release entitled "CoCensys Announces Clinical 3
Results from Phase II Migraine Trial" dated October
16, 1998
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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.
COCENSYS, INC.
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(Registrant)
Date: October 20, 1998 By: /s/ Robert R. Holmen
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Robert R. Holmen, Vice President,
General Counsel and Secretary
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CONTACT: F. RICHARD NICHOL, PH.D. LUCY MORRISON
PRESIDENT & CHIEF EXECUTIVE OFFICER DIRECTOR
COCENSYS, INC. FEINSTEIN KEAN PARTNERS
949/753-6110 OR 753-6122 617/577-8110
JOANN L. DATA, M.D., PH.D.
EXECUTIVE VICE PRESIDENT, PRODUCT
DEVELOPMENT & REGULATORY AFFAIRS
COCENSYS, INC.
949/753-6110 OR 753-6122
COCENSYS ANNOUNCES CLINICAL RESULTS FROM PHASE II MIGRAINE TRIAL
CORPORATE STRATEGY TO LEVERAGE PIPELINE FOR NEAR-TERM VALUE AND
LONG-TERM FINANCIAL STABILITY
IRVINE, CALIFORNIA/PR NEWSWIRE/OCTOBER 16, 1998 - CoCensys, Inc. (Nasdaq: COCN)
today announced results from its Phase II clinical trial using a tablet
formulation of ganaxolone for acute migraine. While the patients receiving
ganaxolone reported pain relief at a rate in excess of those receiving placebo,
the difference was not statistically significant. The Company did achieve
statistically significant results in pain relief at two hours in a subset of
forty-five female patients who were dosed with ganaxolone or placebo within five
days following start of menses. Based on the results of the trial, the Company
intends to seek a collaboration partner to develop ganaxolone for migraine
prophylaxis as well as for epilepsy, for which the drug has shown promising
results in previous clinical trials. The Company also will seek a collaboration
partner to develop backup compounds to ganaxolone for acute migraine therapy.
The migraine trial was a double-blind, placebo-controlled study involving 325
female and male migraine patients at 19 clinical sites throughout the United
States. The out-patient trial was designed to assess the safety, tolerability
and efficacy of a single dose of a tablet formulation of ganaxolone, building on
the encouraging results seen in a prior Phase II clinical trial using a liquid
suspension formula of ganaxolone for acute migraine therapy. Primary endpoints
for the trial were pain relief at two and four hours post-dosing.
Joann L. Data, M.D., Ph.D., Executive Vice President, Product Development and
Regulatory Affairs, reported: "Ganaxolone is a synthetic version of naturally
occurring neuroactive compounds known as epalons which bind to the GABAA
receptors in the brain. This trial once again supported the safety of
ganaxolone and the epalons in general; we did not see any serious adverse events
nor any cardiovascular side effects associated with ganaxolone. The only
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statistically relevant side effects that occurred in patients receiving
ganaxolone were, as predicted, somnolence, dizziness and fatigue."
"Based on the results of the trial, we have initiated a strategy for CoCensys
designed to leverage the Company's very broad scientific and clinical resources
through collaborations," said F. Richard Nichol, Ph.D., President and Chief
Executive Officer of CoCensys. "As of September 30, 1998, we had in excess of
$15 million in cash, which will keep us funded well into 1999. To capitalize
on the value of our portfolio and to ensure the long-term financial stability of
the Company, we will:
- - First, focus immediately on identifying a corporate partner to proceed with
development of ganaxolone for epilepsy. This will capitalize on the
positive results achieved in previous adult and pediatric epilepsy trials.
- - Second, seek a partner to develop ganaxolone for migraine prophylaxis.
Ganaxolone may have a similar mechanism of action to another drug approved
for migraine prophylaxis (divalproex sodium).
- - Third, seek a partner to develop epalon analogs for acute migraine.
- - Fourth, identify a corporate partner for our program to develop sodium
channel blockers for the treatment of neuropathic pain and epilepsy."
Dr. Nichol noted that CoCensys currently has development programs with the
Wyeth-Ayerst Laboratories Division of American Home Products to develop epalons
for the treatment of anxiety and with Warner-Lambert Company to identify and
develop sub-type selective NMDA receptor antagonists for the treatment of a
variety of neurological and psychiatric diseases such as cerebral ischemia,
Parkinson's disease, epilepsy and chronic pain.
CoCensys is a biopharmaceutical company that discovers and develops products for
the treatment of neurological and psychiatric disorders. The Company's product
development programs focus on novel small molecule compounds for the treatment
of epilepsy, anxiety, Parkinson's and other neurodegenerative diseases,
neuropathic pain, migraine, insomnia and stroke. 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.
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