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SECURITIES EXCHANGE AND COMMISSION
Washington, D. C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
APRIL 29, 1997
Date of Report (DATE OF EARLIEST EVENT REPORTED)
COCENSYS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE
(State or other jurisdiction of incorporation)
0-20954 33-0538836
(Commission File Number) (IRS Employer Identification No.)
213 TECHNOLOGY DRIVE
IRVINE, CALIFORNIA 92718
(Address of principal executive offices and zip code)
(714) 753-6100
(Registrant's telephone number, including area code)
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Item 5. OTHER EVENTS.
On April 29, 1997, CoCensys, Inc. (the "Company") announced that Novartis
Pharma A.G. decided not to participate further in the development of ACEA
1021, CoCensys' compound for the treatment of stroke and traumatic brain
injury. The decision was influenced by preliminary results from a recently
completed Phase I safety trial. The research and development agreement
between the Company and Novartis will conclude in October 1997. A copy of
the press release, dated April 29, 1997, is attached as an exhibit hereto.
Item 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
Exhibit
Number Description
- ------- -----------
99.1 Press Release, titled "CoCensys and Novartis End Collaboration
on Development of Stroke Compound," dated April 29, 1997.
2.
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SIGNATURE
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, thereunto duly authorized.
COCENSYS, INC.
Dated: May 2, 1997 By: /s/ Peter E. Jansen
-----------------------------------------
Peter E. Jansen
Vice President and Chief Financial Officer
3.
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EXHIBIT INDEX
Exhibit Sequentially
Number Description Numbered Page
- ------- ----------- -------------
99.1 Press Release, titled "CoCensys and 5
Novartis End Collaboration on Development
of Stroke Compound," dated April 29, 1997
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Exhibit 99.1
COCENSYS AND NOVARTIS END COLLABORATION
ON DEVELOPMENT OF STROKE COMPOUND
COCENSYS TO SEEK NEW CORPORATE PARTNER
IRVINE, California/PR Newswire/April 29, 1997 - CoCensys, Inc. (Nasdaq:
COCN), a biopharmaceutical company engaged in the discovery, development and
commercialization of drugs for the treatment of neurological and psychiatric
disorders, and Novartis Pharma A.G. (formerly Ciba and Sandoz) announced
today that Novartis has decided not to participate further in the development
of ACEA 1021, CoCensys' compound for the treatment of stroke and traumatic
brain injury. ACEA 1021 had been licensed to Ciba. The decision was
influenced by preliminary results from a recently completed Phase I safety
trial.
ACEA 1021, an antagonist of the glycine site of the NMDA receptor, has been
studied in a series of Phase I clinical trials. The drug has been given to
82 healthy volunteers and 60 stroke patients by short intravenous infusion
and by infusion for up to 24 hours. There has been no evidence in any of the
trials of the dose-limiting CNS side effects, such as hallucinations,
delirium, agitation and cardiovascular effects, that have been reported with
some other experimental drugs for these indications. However, preliminary
results from the most recent trial showed crystals of ACEA 1021 in the urine
of some of the subjects. This is a potentially dose-limiting effect that
CoCensys will continue to evaluate.
F. Richard Nichol, Ph.D., CoCensys President and Chief Executive Officer,
said, "Based on published information on other compounds with similar
characteristics, we believe there may be ways to limit such side effects."
More specifically, Dr. Nichol said the company is exploring the
co-administration of probenecid, an approved, commercially available drug
that blocks the secretion of weak acids, such as ACEA 1021, through the
kidneys. Probenecid is successfully used in conjunction with other drugs
already. And because it may prevent the excretion of the drug by the
kidneys, ACEA 1021's primary route of elimination, probenecid may have the
added benefit of reducing the required dose of ACEA 1021.
"We have begun preclinical tests using probenecid and ACEA 1021 together.
These tests are anticipated to help us determine an appropriate dosing
regimen for use in future clinical trials," said Joann L. Data, M.D., Ph.D.,
CoCensys' Senior Vice President of Clinical Development and Regulatory
Affairs.
Despite Novartis' decision not to participate further in trials on ACEA 1021,
William Jenkins, Novartis' head of world wide clinical development and
regulatory affairs commented "Novartis values its relationship with CoCensys,
which has been successful on many levels, and we look forward to the
possibility of future cooperation with the company."
5.
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Dr. Nichol concurred: "CoCensys has enjoyed a good relationship with Novartis
through this project, and we do appreciate their position. At this time, we
are committed to further investigate this compound and to develop it subject
to obtaining a new corporate partner for the program. We also see this
change in corporate relationship as an opportunity to establish a new
development agreement under financial terms that are more favorable to the
company." He noted that CoCensys does not anticipate initiating Phase II
trials until a new corporate collaboration has been established and that ACEA
1021 remains an important compound to be developed in the United States,
where approximately 500,000 strokes occur each year. Under the terms of the
Novartis agreement, Novartis and CoCensys were each paying half of the U.S.
development costs for ACEA 1021. CoCensys regains all rights to the drug
and, in exchange, will reimburse Novartis only from future sales of ACEA 1021.
The forward-looking statements contained above 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 uncertainties of preclinical and clinical
testing and others that are more fully discussed in the company's most recent
Form 10-K.
CoCensys is a biopharmaceutical company that discovers, develops and markets
products to treat neurological and psychiatric disorders. The company's
product development programs focus on three, proprietary technology
platforms: GABA(A) receptor enhancers or Epalons, to treat epilepsy,
migraine, anxiety and insomnia; glutamate antagonists to treat stroke, head
trauma, epilepsy and Parkinson's disease; and ICE-like protease inhibitors
for the treatment of neurodegenerative diseases that involve apoptosis or
programmed cell death. CoCensys has research and development agreements with
Warner-Lambert and G.D. Searle and Co. Through its co-promotion alliances,
CoCensys' Pharmaceutical Sales and Marketing Division markets
Warner-Lambert's Parke-Davis Division's Cognex-Registered Trademark- for the
treatment of Alzheimer's disease and Somerset Pharmaceuticals'
Eldepryl-Registered Trademark- for Parkinson's disease to neurologists. More
information about the company is available on its website:
http://www.cocensys.com.
Novartis is a world leader in Life Sciences with its core businesses in
Healthcare, Agribusiness and Nutrition. In 1996, Novartis achieved Group
sales of 27.6 billion Swiss francs, of which 16.3 billion were in Healthcare,
7.6 billion in Agribusiness and 3.7 billion in Nutrition, and invested more
than 3 billion Swiss francs on research and development. Headquartered in
Basel, Switzerland, Novartis employs 90,000 people in more than 100 countries
around the world.
6.
