Cortex Pharmaceuticals Inc., a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea, has entered into an agreement with Biovail Laboratories International SLR, a wholly owned subsidiary of Valeant Pharmaceuticals International Inc., to regain the AMPAKINE® assets and rights related to respiratory depression.

The new agreement follows Biovail’s purchase of the rights and compounds from Cortex in March 2010. Following the September 2010 merger of Biovail and Valeant, a financial review of the product development pipeline led the combined company to make the decision that Biovail would exit the program, allowing for discussions between Biovail and Cortex.

Per the new agreement, Cortex will make a $200,000 upfront payment to Biovail in addition to potential future payments of up to $15.15 million based on the achievement of certain development and NDA submission and approval milestones. Biovail is also eligible to receive additional payments based on Cortex’s net sales of an intravenous dosage form of the compounds for respiratory depression up to a maximum of $15 million. Biovail also retains an option to co-develop and co-market intravenous dosage forms of AMPAKINE following completion of phase I clinical studies and prior to the end of phase IIa clinical studies.

“We are pleased that both companies were able to reach an agreement for the return of all AMPAKINE assets and intellectual property sold early last year to Biovail,” Mark A. Varney, Ph.D., president and CEO of Cortex stated in the press release.

According to the press release, the assets repurchased by Cortex include the phase II AMPAKINE, CX717; the rights to an injectable form of CX1739 and all dosage forms of CX1942, the first water soluble intravenous pro-drug for an AMPAKINE compound; and the exclusive global patent rights for the use of AMPAKINE compounds for the treatment of respiratory depression. In accordance with the original agreement with Biovail, Cortex had retained rights to all non-intravenous dosage forms of CX1739 and to the use of AMPAKINE compounds as a treatment for sleep apnea.

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