Ampakine Economics :Cortex Pharmaceuticals
Press Release from Cortex Pharmaceuticals, October 6, 2011
Servier Exercises Option to Cortex’s Ampakine® CX1632, an Innovative Compound in Clinical Development for Alzheimer’s Disease
— Cortex to Receive an Additional $2 Million —
IRVINE, CA (October 6, 2011) — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) has received written notification from Servier of its decision to exercise its option to obtain all the remaining rights to the jointly discovered high impact Ampakine® compound, CX1632 (S47445). In connection with the option exercise, Servier will pay Cortex an additional $2,000,000, as well as certain royalties and milestone payments.
Servier, France’s largest privately held pharmaceutical firm, paid Cortex a non-refundable payment of $1,000,000 for the option in June 2011. Since then, Servier has completed a Phase I clinical study with the compound. With the option exercise, Servier will acquire exclusive rights to develop and market CX1632/S47445 on a worldwide basis. However, Cortex retains all rights for its remaining compounds and AMPAKINE technology on a global basis.
“Servier has been an excellent partner and we are pleased with their decision to exercise this option to continue with the clinical development of the high impact Ampakine CX1632/S47445,” said Mark Varney, Ph.D., Cortex’s President and CEO. “High impact Ampakine molecules such as CX1632/S47445 may well represent a disease-modifying approach to treating memory and cognitive impairments in patients with Alzheimer’s disease and other disorders, given the demonstrated ability of the compounds to stimulate protective growth factors within the brain.”
“We are very pleased to acquire from Cortex the remaining rights for this jointly discovered compound as it will allow us to expand our activities worldwide. S47445 is now in clinical development as a potential “first in class” compound. Such development exemplifies our commitment to finding innovative treatments for patients suffering from Alzheimer’s disease, and our belief that AMPA modulation is a promising way to improve cognitive disorders in such patients,” said Emmanuel Canet, MD, PhD, Head of Servier R&D.
About Servier
Servier is a privately-run French research-based pharmaceutical company with a 2010 turnover of €3.7 billion. Servier invests 25% of its turnover in R&D. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees. More information at: www.servier.com
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea. Cortex is pioneering a class of proprietary pharmaceuticals called Ampakine compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the Ampakine technology. Additionally, recent studies have shown that the Ampakine compounds also impact areas in the brain stem that control breathing. Recent work has focused on the potential treatment of sleep apnea disorders which can have a deleterious impact on numerous disease states including congestive heart failure. Also, respiratory depression caused by opioid analgesics, anesthetic agents and benzodiazepines can be reduced by AMPAKINE compounds. For additional information regarding Cortex, please visit the Company’s website at http://www.cortexpharm.com
Forward-Looking Statement
Note — This press release contains forward-looking statements concerning the Company’s research and development activities. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The success of such activities depends on a number of factors, including the risks 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 patents may not issue from the Company’s patent applications; that competitors may challenge or design around the Company’s patents or develop competing technologies; that the Company may have insufficient resources to undertake proposed clinical studies and that preclinical or 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 preclinical and clinical testing and regulatory approval. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
More information at www.cortexpharm.com
Contacts:
Company Contact:
Mark A. Varney, Ph.D.
President ad CEO
Cortex Pharmaceuticals, Inc.
949.727.3157 949.727.3157
Investor Contact:
Erika Moran/Dian Griesel, Ph.D.
Media Contact:
Janet Vasquez
The Investor Relations Group
212.825.3210 212.825.3210
This book section: ADHD Medication Issues and Research
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ADHD Medication Ampakine CX717 Trials Rejected -Press Release 2007
Editor: Background information from wikipedia on Ampakine:
Ampakines are a new class of modified benzamide compounds known to enhance attention span and alertness. Their action is theorized to be due to facilitation of transmission at cortical synapses that use glutamate as neurotransmitter. This in turn may promote plasticity at the synapse, which could translate into better cognitive performance. The ampakines take their name from the glutamatergic AMPA receptor, which they strongly interact with.
Unlike older stimulant medications (e.g. caffeine, methylphenidate (Ritalin®), and the amphetamines), ampakines do not seem to have unpleasant, long-lasting side effects such as
sleeplessness. They are currently (2005) investigated as potential treatment for a range of conditions involving mental disability such as Alzheimer's disease, Parkinson's disease, schizophrenia or neurological disorders as Attention Deficit Hyperactivity Disorder (ADHD), among others. In a 2006 study they were shown to have an effect after they had left the body, continuing to enhance learning and memory. Some examples include: CX-516 (Ampalex), CX546, CX614 and CX717.
FDA’s Psychiatric Division has Rejected Cortex’s Request to Study CX717 in Phase IIb ADHD Medication Study
— Company plans to focus on Alzheimer’s disease PET scan study and the treatment of acute respiratory depression with CX717 —
Irvine, CA (October 11, 2007) – Cortex Pharmaceuticals, Inc (AMEX:COR) was informed on Wednesday, October 10, 2007, that the Food and Drug Administration (FDA) would soon be sending it formal notice that the agency would not approve Cortex’s Investigational New Drug Application for a Phase IIb study of CX717 in attention deficit hyperactivity disorder, or ADHD. The denial is based on results of animal toxicology studies filed by Cortex. As a result, the company has requested that the Division of Psychiatry Products (DPP) of the FDA inactivate its IND Application for ADHD.
The company has chosen at this time to not formally withdraw the IND Application in order to evaluate the formal response from the FDA. It will weigh the potential for providing additional data if the potential exists for re-activating the IND at a later date. While the company will need some time to review the specifics of the FDA’s written concerns, at this time Cortex does not believe it likely that a resubmission will occur.
However, Cortex clearly intends to continue its plans to develop CX717 for the acute treatment of respiratory depression (RD) and continue its study of CX717 in its Alzheimer’s disease PET scan study. Cortex believes that the IND application previously filed with the Division of Neurology Products of the FDA for the treatment of Alzheimer’s disease will not be affected by the actions of the DPP.
Cortex believes that by developing an acute use for CX717, such as treatment of respiratory depression, the risks perceived to be associated with higher chronic doses required for ADHD can be mitigated. Additionally, the risk/benefit ratio for the treatment of patients with life-threatening respiratory depression is substantially different than for the treatment of ADHD. Also, Cortex’s preclinical data for improvement of memory and cognition in animals consistently shows that the dose level of CX717 is 5-10 fold less than that required in animal models of ADHD. Hence, either lower dosage levels for chronic administration and/or acute uses are possible options for the continued development of CX717.
Finally, Cortex is committed to continuing the development of other compounds such as CX701, which the company believes will go into Phase I clinical trials shortly, and other low and high impact Ampakine® compounds which are currently in the preclinical pipeline. While this decision by the FDA represents a significant setback for the company, Cortex has a broad-based technology platform that is currently producing several other significant future clinical candidates.
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. Cortex is pioneering a class of proprietary pharmaceuticals called Ampakine compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the Ampakine technology. Cortex has an alliance with N.V. Organon for the treatment of schizophrenia and depression. In December 2006, Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of Ampakine compounds in the treatment of neurodegenerative diseases on a global basis. Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing Ampakine compounds. For additional information regarding Cortex, please visit Cortex Pharmaceuticals’ Website at www.cortexpharm.com.
Forward-Looking Statement
Note – This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed compounds may at any time be found to unsuitable for moving into clinical studies or be unsafe or ineffective for the indications under clinical test and that pre-clinical and 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. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease.
ADHD Medication Cortex Pharmaceuticals