Insys Therapeutics Announces Development of Pharma Cannabidol For Epilepsy, Sees Filing IND By 2H'14

Insys Therapeutics, Inc.

announced today plans to advance development of its pharmaceutical Cannabidiol (CBD), a synthetically produced and over 99% pure form of cannabidiol, to treat epilepsy in children and adults. Insys has engaged a large international Clinical Research Organization to provide development and regulatory services and has hired Mark Davis as Senior Clinical Director to oversee this program. Insys plans to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) in the second half of 2014 for CBD for the treatment of epilepsy. In pediatrics, Insys plans to pursue development of treatments for Lennox-Gastaut Syndrome and Dravet Syndrome, which are orphan indications. "We are excited to take these important steps, which we believe pave the way to advance our pharmaceutical CBD candidate into clinical trials to treat these severe forms of epilepsy," said Michael L. Babich, President and Chief Executive Officer. "We have a unique opportunity to produce a tested and controlled pharmaceutical cannabinoid treatment that can make a substantial difference in the lives of patients with epilepsy." "As a further indication of our commitment to bring to market our pipeline of innovative pharmaceutical CBD therapies that potentially provide significant medical benefits to patients, we are pleased to announce the appointment of Mark Davis as Senior Clinical Director," said Mr. Babich. Mr. Davis has more than 30 years of experience in pharmaceutical/biotech and medical device development, most recently at Medicis Pharmaceutical Corporation (now Valeant Pharmaceuticals International, Inc.) as Executive Director of Clinical Research. Prior to that, Mr. Davis spent 12-years at Amgen in various senior level positions including the Associate Director of Clinical Research. He also held additional senior clinical positions at Topica Pharmaceuticals, Onyx, Medtronic and Stiefel Laboratories. Mr. Davis has a Master's in Biomedical Engineering from the University of Utah. Insys has the capability to manufacture pharmaceutical CBD in its Austin, Texas manufacturing facility. Insys believes that it is the only U.S. company with the capacity to produce pharmaceutical CBD in large quantities. In addition to the use of this pharmaceutical cannabinoid for the treatment of epilepsy, Insys is evaluating its potential utility in several other indications, including: Peripheral neuropathy in taxol-treated patients; Addiction in cocaine, heroin and opioids; and, Glioblastoma. The company intends to pursue orphan drug designation for all indications that qualify for orphan drug status. To qualify for orphan drug status, patient populations cannot exceed 200,000 patients.