Cortex enters agreement with Biovail to regain AMPAKINE assets and rights

Mar 16 2011

Cortex Pharmaceuticals, Inc. (OTCBB: CORX) announced that it has entered into an agreement with Biovail Laboratories International SRL ("Biovail"), a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. ("Valeant"), to regain the AMPAKINE® assets and rights related to respiratory depression.

Under the new agreement, Cortex will make an upfront payment to Biovail of $200,000, and 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. In addition, at any time following completion of Phase I clinical studies and prior to the end of Phase IIa clinical studies, Biovail retains an option to co-develop and co-market intravenous dosage forms of an AMPAKINE compound as a treatment for respiratory depression.

Biovail previously purchased these rights and compounds from Cortex in March 2010. Following its merger in September 2010, Valeant and Biovail conducted a strategic and financial review of the product development pipeline. As a result of that review, the decision was made that Biovail would exit this program and discussions were entered into between Biovail and Cortex.

"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," commented Mark A. Varney, Ph.D., President and CEO of Cortex.

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; along with the exclusive global patent rights for the use of AMPAKINE compounds for the treatment of respiratory depression. Under 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.

Cortex earlier performed two phase IIa studies in Germany to obtain clinical "proof-of-concept" for the prevention of opiate-induced respiratory depression in humans. In these double-blind, placebo-controlled, crossover studies, baseline breathing rates were significantly depressed by the potent opiate, alfentanil. A single oral dose of CX717 prevented alfentanil-induced respiratory depression without interfering with the analgesic effects of the opiate. The opiate antagonist, naloxone, also reversed alfentanil-induced respiratory depression, as expected, but it reversed the pain-relieving properties of the opiate as well. The differentiating effect of the AMPAKINE technology is the ability to prevent respiratory depression, while maintaining the opiate's analgesic effect.