Biovail is paying Cortex Pharmaceuticals an initial $10 million for a number of the latter’s clinical- and preclinical-stage ampakine compounds and associated IP relating to brain-mediated breathing disorder, respiratory depression, and vaso-occlusive crisis associated with sickle cell disease.
Cortex could earn up to another $15 million from Biovail in the form of defined clinical development milestones. The firm retains rights to develop the nonlicensed ampakine compounds for indications excluding respiratory depression including neurodegenerative diseases.
The products acquired by Biovail include the Phase II lead compound, CX717, along with the preclinical compounds CX1763 and CX1942 and an injectable dosage form of CX1739. The companies comfirmed that Cortex will also be permitted to continue its clinical development of oral CX1739 as a treatment for sleep apnea.
“As a result of this transaction, we will be in the position to continue the oral Phase IIa sleep apnea trail with CX1739 and initiate a Phase II clinical trial for the treatment of ADHD very soon,” comments Mark A Varney, Ph.D., president and CEO. “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.”
Cortex’ ampakine compounds are designed to boost the activity of the AMPA receptor. The technology comprises two groups of compounds designated as either “low impact” or “high impact.” While both types of compounds positively modulate the AMPA receptor function, the high impact compounds also activate the expression of growth factors within the brain, Cortex reports. This effect gives the compounds additional potential for disease-modifying activity.
Biovail says that the acquisition represents its eighth transaction since it implemented a specialty central nervous system (CNS) disease strategy in 2008. “CX717 has the potential to address a significant unmet medical need and would fit nicely with the hospital sales force we intend to deploy for Staccato® loxapine,” states Bill Wells, Biovail’s CEO.
In February 2010, Biovail Laboratories negotiated a deal with Alexza Pharmaceuticals for U.S. and Canadian commercialization rights to AZ-004, a formulation of loxapine administered via deep-lung inhalation using Alexza's Staccato device. The product is initially under regulatory review by the FDA for use in the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. Biovail and Alexza say a response to the filing is expected from the agency during October.
Biovail has four other CNS drugs in mid- to-late stage clinical development. Primavanserin is in development as a treatment for Parkinson disease psychosis and Alzheimer disease psychosis as well as in schizophrenia as an adjunctive therapy. BVF-018, a modified-release formulation of tetrabenazine, is in development for the treatment of Tourette syndrome.