IRVINE, Calif.--(BUSINESS WIRE)--Jan. 7, 2004--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) announced that it has received the milestone payment from NV Organon to retain the worldwide rights to develop and commercialize the Company's proprietary AMPAKINE® technology for the treatment of depression. This $2 million milestone payment comes three years after Organon exercised its option to do additional research and development with various AMPAKINE compounds in various depression pre-clinical models. This is the second large psychiatric indication in which Organon has rights to develop a unique AMPAKINE compound to market. Organon is currently in Phase II clinical trials with another AMPAKINE, ORG 24448, to treat patients with schizophrenia.
In January 1999, Cortex and Organon entered an exclusive worldwide license agreement that enables Organon to develop and commercialize the AMPAKINE compounds for the treatment of schizophrenia. The agreement with Organon included an option for a similar license in the field of depression, which Organon exercised on January 6, 2001.
"We are very pleased that Organon chose to continue to invest in our AMPAKINE technology and to continue its research and development of the depression indication," stated Roger G. Stoll, Ph.D., Chairman, President and Chief Executive Officer of Cortex. "Given Organon's successful marketing of Remeron® (mirpazapine) and their solid business knowledge of the worldwide anti-depressant market, we believe that this payment reaffirms the potential of the AMPAKINE technology." This investment by Organon will allow them to continue to develop this novel therapy for patients with depression, and builds on the current work they are conducting in the field of schizophrenia where they currently have a lead AMPAKINE product, ORG 24448, in Phase II clinical trials.
Cortex Pharmaceuticals, Inc.
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 AMPAKINE compounds, which act on the AMPA receptors on neurons to increase the strength of signals at connections between these brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in various neurological and psychiatric diseases. The AMPAKINE compounds are currently being evaluated in clinical trials for treatment of Alzheimer's disease, Mild Cognitive Impairment, schizophrenia, fragile X syndrome, autism and sleep deprivation effects. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety disorders.
Note -- This press release contains forward-looking statements concerning the Company's and its strategic partners' research and development activities, clinical trials 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 obtain additional capital needed to continue its operations; that the agreements with Organon and Servier will not result in any commercial products or that any additional milestone payments will be earned by the Company; that the Company may be unable to arrive at additional corporate partnerships with other pharmaceutical companies on acceptable terms and therefore be required to independently fund clinical development of AMPAKINE compounds through the sale of additional equity securities or otherwise; that the Company's proposed products may at any time be found to be unsafe 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 and its strategic partners' proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.
Company Contact: Roger G. Stoll, Ph.D. Chairman, President and CEO Cortex Pharmaceuticals, Inc. 949-727-3157 or
Investor Contact: Jane Lin/ Dian Griesel, Ph.D. The Investor Relations Group 212-825-3210
Source: Cortex Pharmaceuticals, Inc.