CORX - HUGE NEWS JUST OUT
Wednesday January 13, 2:15 pm Eastern Time
Company Press Release
SOURCE: Cortex Pharmaceuticals, Inc.
Cortex Licenses Ampakine Rights to
Organon for Schizophrenia and Depression
IRVINE, Calif., Jan. 13 /PRNewswire/ -- Cortex Pharmaceuticals, Inc. (Nasdaq: CORX - news)
and NV Organon, a pharmaceutical business unit of Akzo Nobel (The Netherlands), have entered
into an exclusive worldwide license agreement that will enable Organon to develop and
commercialize Cortex's proprietary Ampakine® technology for the treatment of schizophrenia and
explore it in the area of depression.
The agreement includes an upfront payment, research and development payments for two years,
and milestone payments, plus royalty payments on worldwide sales. Financial details were not
disclosed.
Organon, based in Oss, The Netherlands, employs almost 10,000 persons world-wide, over
1,500 of whom are involved in research and development. Its pharmaceutical products are sold in
more than 100 countries. Akzo Nobel reported $12 billion in annual sales for 1997.
''We are very pleased and proud to have Organon as our corporate partner for developing a
completely new therapy for these two critical diseases,'' said Vincent F. Simmon, Ph.D., President
and CEO of Cortex. ''This will enable an accelerated program to bring the Ampakines to market,
if proven safe and effective in clinical trials.''
''We have a strong research and development program in schizophrenia and a solid business in
anti-depressants and are therefore interested in new and different approaches to the treatment of
these diseases,'' said Driek Vergouwen, Organon's Managing Director of Research &
Development. ''Our recently expanded research site in Newhouse, Scotland, has the expertise to
investigate Cortex's Ampakines. The approach the Ampakines offer is genuinely new.''
Ampakines modulate the function of the AMPA receptor, a vital part of the communication system
between nerve cells in the brain. In patients with schizophrenia, areas of the brain rich in AMPA
receptors are much less active than in individuals who do not have the disease. Cortex's Ampalex®
(CX516) is currently the subject of two early-stage clinical trials for the treatment of schizophrenia
to investigate if improving communication in these important areas of the brain may have a positive
effect on some of the symptoms associated with schizophrenia. Preliminary results of these trials
have shown the drugs to be well tolerated and suggest improvements in some measures of
cognition and attention.
The Ampakines were originally developed to improve memory and the realization that they might
have some benefit in the treatment of depression was fortuitous. Researchers evaluating Cortex's
compounds noted that Ampakines had the effect of inhibiting REM sleep. The observed effect on
REM is characteristic of the majority of anti-depressants. Subsequent preclinical experiments
performed by Cortex and its collaborators provided additional encouraging data for this important
indication. In addition, there is very preliminary evidence that Ampalex may have a beneficial effect
on depression in patients with schizophrenia.
''This is the first of what we hope will be a number of partnerships for the development of
Ampakines,'' stated Dr. Simmon. ''In addition to these two important indications, we hope to
establish relationships that will accelerate our development of Ampakines for the treatment of
Alzheimer's disease and other age-related memory disorders, as well as a number of other mental
disorders.''
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies
for neurological and psychiatric disorders. The Company is pioneering a class of proprietary
pharmaceuticals called Ampakines®, which act to increase the strength of signals at connections
between brain cells. Aberrant neural connections or loss of these connections is believed to be
responsible for the memory difficulties associated with Alzheimer's disease and to contribute to the
memory and cognitive dysfunction seen in schizophrenia.
NV Organon develops and produces pharmaceutical products in fields such as gynecology,
psychiatry, athero-thrombosis and auto-immune diseases. Major product groups are oral
contraceptives, infertility treatments, and preparations for menopausal complaints, depression and
psychosis. The company employs almost 10,000 employees worldwide. The company invests
almost 17 percent of its sales income in its drug discovery and development programs.
NV Organon is one of the pharmaceutical business units of Akzo Nobel. Akzo Nobel, based in the
Netherlands, serves customers throughout the world with healthcare products, coatings, chemicals,
and fibers. The fiber business, now known as Acordis, will be demerged in the course of the
second half of 1999. The company currently employs 87,500 people in more than 60 countries.
Consolidated sales for 1997 totaled NLG 24.1 billion (USD $12 billion / EUR 10.8 billion ).
Note -- This press release contains forward-looking statements concerning the Company's
research and development activities and business development plans. Actual results may differ
materially, depending on a number of risk factors, including the risks that the Company may be
unable to secure additional capital needed to continue its operations; that the agreement with
Organon will not result in any commercial products or that any milestone payments will be earned
by the Company, that the Company may be unable to arrive at other corporate partnerships with
larger pharmaceutical companies on acceptable terms and therefore be required to independently
fund clinical development of Ampakines through the sale of additional equity securities or
otherwise; that the Company's proposed products may at any time be found to be toxic or
ineffective for any or all of their proposed indications; that competitors may challenge or design
around the Company's patents or develop competing technologies; and that clinical studies may at
any point be suspended or take substantially longer than anticipated to complete. As discussed in
the Company's Securities and Exchange Commission filings, the Company's proposed products
will require additional research, lengthy and costly clinical testing and regulatory approval.
Ampakines are investigational drugs and have not yet been shown to have efficacy in the treatment
of any disease.
SOURCE: Cortex Pharmaceuticals, Inc.
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