Cortex Pharmaceuticals has agreed to pay up to $30.4 million to regain assets and rights it sold last year to Biovail Laboratories covering Ampakine compounds for the treatment of respiratory depression. At any time following completion of Phase I studies and before the end of Phase IIa studies, Biovail retains an option to co-develop and co-market intravenous dosage forms of an Ampakine compound for respiratory depression.
Under terms of the agreement Cortex will pay Biovail $200,000 up front and make up to $15.15 million in potential future payments based on achieving development, NDA submission, and approval milestones. Biovail could also receive up to a maximum $15 million in additional payments based on Cortex’s net sales of an intravenous dosage form of the compounds for respiratory depression.
Biovail, a wholly owned subsidiary of Valeant Pharmaceuticals, bought Ampakine rights and compounds from Cortex in March 2010. Six months later, after Valeant and Biovail agreed to a $3.2 billion merger, the companies conducted a strategic and financial review of their product development pipelines. This led to talks with Cortex about Biovail exiting the drug program.
Assets repurchased by Cortex include the Phase II candidate CX717, the rights to an injectable form of CX1739, and all dosage forms of CX1942, a water soluble intravenous pro-drug for an Ampakine compound. Cortex also regains exclusive global patent rights for the use of Ampakine compounds for the treatment of respiratory depression. Under the original agreement with Biovail, Cortex owned rights to all nonintravenous dosage forms of CX1739 and to the use of Ampakine compounds as a treatment for sleep apnea.
Cortex has performed two Phase IIa studies in Germany to obtain clinical proof-of-concept for the prevention of opiate-induced respiratory depression in humans. In double-blind, placebo-controlled, crossover studies, baseline breathing rates were significantly depressed by alfentanil. A single oral dose of CX717 prevented alfentanil-induced respiratory depression without interfering with the opiate’s analgesic effects. Another opiate, naloxone, also reversed alfentanil-induced respiratory depression as expected, but it reversed alfentanil’s pain-relieving properties as well.