UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 30, 2011
CORTEX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 1-16467 | 33-0303583 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
15241 Barranca Parkway, Irvine, California |
92618 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (949) 727-3157
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 | Entry into a Material Definitive Agreement. |
(a) | Patent Assignment and Option and Amended and Restated Agreement with Les Laboratoires Servier |
As previously reported, in October 2000 Cortex Pharmaceuticals, Inc., a Delaware corporation (the Company), entered into a licensing agreement (the Prior Agreement) with Adir et Compagnie (which entity subsequently merged with its parent, Les Laboratoires Servier and is referred to herein as Servier), under which the Company granted certain license rights to Servier. As also previously reported, on June 10, 2011, the Company and Servier entered into a Patent Assignment and Option and Amended and Restated Agreement (the Amended and Restated Agreement) in order to, among other things, provide Servier with an exclusive option (the Option) to purchase the Companys remaining rights to the jointly discovered high impact AMPAKINE® compound, CX1632 (S47445). The Amended and Restated Agreement included an immediate upfront non-refundable payment by Servier of $1,000,000 for the Option, which the Company received during June 2011.
In accordance with the terms of the Amended and Restated Agreement, Servier provided notification to the Company of its exercise of the Option on September 30, 2011. As a result, the Company will receive an additional $2,000,000 from Servier and Servier will be required to pay certain royalties and milestone payments to the University of California (either directly or indirectly through the Company per the terms of the Amended and Restated Agreement). Additionally, as a result of Serviers exercise of the Option, (i) the Company will execute a patent assignment, (ii) Servier will acquire sole ownership of the global patent rights to CX1632, along with a sub-license of the Companys rights to all indications licensed from the University of California for use with CX1632, and (iii) the Company will not be entitled to any royalties or further payments from Serviers development and commercialization of CX1632. As part of the Amended and Restated Agreement, the Company agreed to waive its rights to any causes of action against Servier for infringement of any patent rights claiming the composition of matter of CX1632 (to the extent of the composition of matter of CX1632 only) that it may have in connection with the development, manufacture, use, commercialization, distribution and sale of any composition for administration to humans containing CX1632 as a pharmaceutically active ingredient.
On October 6, 2011, the Company issued a press release announcing Serviers exercise of the Option. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
The foregoing summary of the Amended and Restated Agreement is qualified in its entirety by reference to such Agreement, a copy of which was filed as an exhibit to the Companys Form 10-Q for the quarterly period ended June 30, 2011.
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Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. |
Description | |
99.1 | Press Release dated October 6, 2011. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Current Report to be signed on its behalf by the undersigned, hereunto duly authorized.
CORTEX PHARMACEUTICALS, INC. | ||||
Dated: October 6, 2011 | By: | /s/ Maria S. Messinger | ||
Maria S. Messinger, Vice President and Chief Financial Officer |
S-1
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release dated October 6, 2011. |
Exhibit 99.1
PRESS RELEASE
Company Contact: | Investor Contact: | |
Mark A. Varney, Ph.D. | Erika Moran/ Dian Griesel, Ph.D. | |
President and CEO | Media Contact: | |
Cortex Pharmaceuticals, Inc. | Janet Vasquez | |
949.727.3157 | The Investor Relations Group | |
212.825.3210 |
SERVIER EXERCISES OPTION TO CORTEXS AMPAKINE®
CX1632, AN INNOVATIVE COMPOUND IN CLINICAL
DEVELOPMENT FOR ALZHEIMERS 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, Frances 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., Cortexs 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 Alzheimers 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
Alzheimers 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 Alzheimers disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brains 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 Companys website at http://www.cortexpharm.com
Forward-Looking Statement
Note This press release contains forward-looking statements concerning the Companys 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 Companys current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Companys 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 Companys patent applications; that competitors may challenge or design around the Companys 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 Companys Securities and Exchange Commission filings, the Companys 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
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