(PR NEWSWIRE) Cortex Licenses Ampakine Rights to Organon for Schizophrenia
Cortex Licenses Ampakine Rights to Organon for Schizophrenia and Depression
IRVINE, Calif., Jan. 13 /PRNewswire/ -- Cortex Pharmaceuticals, Inc.
(Nasdaq: CORX) 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(R) 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(R) (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(R), 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.
-0- 01/13/99
/CONTACT: Vincent F. Simmon, Ph.D., President and CEO of Cortex
Pharmaceuticals, Inc., 949-727-3157; Bruce Russell, Investor Relations,
Russell Communications Group for Cortex Pharmaceuticals, Inc., 310-216-1414;
or Dr. B.J. Oddens, International Communications of NV Organon,
+31-412-66-28-61/
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 208450/
/Web site: cortexpharm.com
(CORX)
CO: Cortex Pharmaceuticals, Inc.; NV Organon; Akzo Nobel
ST: California; The Netherlands
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