-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BEzaZbuQIWyNDTLHSQqXbDkPFIaMVdSzGYRZP+fJfljjpttVT/iMJJYdM92bnswM eI8YTDhK0/W9ADhD+9QVIw== 0001193125-10-073379.txt : 20100331 0001193125-10-073379.hdr.sgml : 20100331 20100331160629 ACCESSION NUMBER: 0001193125-10-073379 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100325 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100331 DATE AS OF CHANGE: 20100331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CORTEX PHARMACEUTICALS INC/DE/ CENTRAL INDEX KEY: 0000849636 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330303583 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-16467 FILM NUMBER: 10719152 BUSINESS ADDRESS: STREET 1: 15241 BARRANCA PKWY CITY: IRVINE STATE: CA ZIP: 92718 BUSINESS PHONE: 7147273157 MAIL ADDRESS: STREET 1: 15241 BARRANCA PARKWAY CITY: IRVINE STATE: CA ZIP: 92718 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

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): March 25, 2010

 

 

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)

Registrant’s 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.

Asset Sale to Biovail Laboratories International SRL

On March 25, 2010, Cortex Pharmaceuticals, Inc., a Delaware corporation (the “Company”) entered into an Asset Purchase Agreement (“Asset Purchase Agreement”) with Biovail Laboratories International SRL, an international society with restricted liability organized under the laws of Barbados (“Biovail”). Pursuant to the Asset Purchase Agreement, Biovail acquired the Company’s interests in certain pharmaceutical compounds and related intellectual property (the “Asset Sale”) for use in the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease (the “Field”). The assets acquired by Biovail in the transaction include: (i) the Phase II compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739 (collectively, the “primary AMPAKINE® compounds”), (ii) certain other AMPAKINE® compounds, specifically, the molecules disclosed in, claimed in or otherwise covered by the patent families acquired pursuant to the Asset Purchase Agreement (other than the primary AMPAKINE® compounds), which are being or may be developed, among other things, for use in the Field, and (iii) certain method of use patents and related assets (the “Acquired Assets”). In connection with the Asset Sale, Biovail agreed to assume certain liabilities and obligations of the Company related to the Acquired Assets.

Pursuant to the terms of the Asset Purchase Agreement, Biovail paid the Company the lump sum of $9,000,000 upon the execution of the Asset Purchase Agreement, and Biovail will also pay to the Company $1,000,000 upon the later of the completion of the specified transfer plan or six months following the execution of the Asset Purchase Agreement. In addition, the Company will have the right to receive up to three milestone payments in an aggregate amount of up to $15,000,000 plus the reimbursement of certain related expenses, each conditioned upon the occurrence of particular events relating to the clinical development of certain Acquired Assets.

As part of the Asset Sale, (i) the Company and Biovail entered into a Seller License Agreement, dated as of March 25, 2010 (“Seller License Agreement”), which provides for the license back to the Company of certain rights to some of the Acquired Assets for use other than in the Field (the “License Back”), (ii) the Company assigned and transferred to Biovail that certain Patent License Agreement entered into by and between the Company and The Governors of the University of Alberta dated as of May 9, 2007, as amended on June 8, 2007, and (iii) Biovail entered into a license agreement with the Regents of the University of California relating to the use of certain AMPAKINE® compounds in the Field.

On March 26, 2010, the Company issued a press release describing this transaction. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K.

The foregoing summary is qualified in its entirety by reference to the Asset Purchase Agreement and the Seller License Agreement, copies of which will be filed as exhibits to the Company’s Form 10-Q for the quarterly period ended March 31, 2010. The Company intends to submit a FOIA confidential treatment request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Asset Purchase Agreement and the Seller License Agreement. The omitted material will be included in the request for confidential treatment.

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

See the disclosure set forth in Item 1.01, which is incorporated by reference into this Item 2.01.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits.

 

Exhibit No.

    

Description

99.1

     Press Release dated March 26, 2010.

 

2


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: March 31, 2010     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 March 26, 2010.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

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

Cortex Sells Selected Ampakine Compounds and Rights to Respiratory Depression Indication to Biovail

— Purchase Price of $10 Million and up to $15 Million Clinical Development Milestones —

IRVINE, CA (March 26, 2010) — Cortex Pharmaceuticals, Inc. (OTCBB (CORX.OB)) announced that it has entered into an agreement with Biovail Laboratories International SRL (“Biovail”) in which Biovail acquired certain AMPAKINE compounds and the rights to the patent filing for respiratory depression and vaso-occlusive crises associated with sickle cell disease. The transaction with Biovail includes a purchase price of $10,000,000 and additional payments of up to $15,000,000 based upon defined clinical development milestones.

The agreement includes the transfer of rights to Biovail for certain AMPAKINE compounds, including the Phase II compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739 and the indication of respiratory depression. Specifically, the agreement allows Cortex to retain its rights to non-injectable dosage forms of CX1739 for all uses outside of respiratory depression. Biovail will allow Cortex to continue to pursue the treatment of sleep apnea for which a clinical trial is currently underway.

The transaction follows the earlier results from two of the Company’s Phase IIa studies in which administration of CX717 prevented the onset of respiratory depression induced by an opioid, while preserving the opioid’s pain-relieving effects. “We are pleased that Biovail has recognized the potential of our AMPAKINE technology,” commented Mark A. Varney, Ph.D., President and CEO of Cortex. “We believe the technology may ultimately be useful in reversing or preventing respiratory depression in patients undergoing surgical procedures.”

Cortex retains all rights to the non-acquired AMPAKINE compounds for treatment of neurodegenerative diseases and psychiatric diseases which historically have been part of its portfolio. “As a result of this transaction, we will be in the position to continue the oral Phase IIa sleep apnea trial with CX1739 and to initiate a Phase II clinical trial for the treatment of ADHD very soon,” commented Mark A Varney. “Additionally, we are pushing ahead to develop the CX2007 and CX2076 series of compounds and move one of those analogs into the clinic as soon as possible.”

SunTrust Robinson Humphrey served as financial advisor to Cortex.

Cortex will host a conference call on March 29, 2010 at 1:30 PM Pacific Daylight Time to discuss the transaction with Biovail. To access the live conference call, U.S. and Canadian participants may dial (877) 407-8035 and international participants may dial (201) 689-8035. A telephonic replay of the conference call will be available for 30 days after the call by dialing (877) 660-6853 (domestic) or (201) 612-7415 (international) and entering account number 286 and conference call number 348077 when prompted.

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. 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

#  #  #  #  #

 

2

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