SOURCE: INSYS Therapeutics

Insys Therapeutics

February 26, 2015 07:00 ET

Insys Therapeutics Announces Its Pharmaceutical Cannabidiol Received Fast Track Designation From FDA for the Treatment of Dravet Syndrome

PHOENIX, AZ--(Marketwired - Feb 26, 2015) -  Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its pharmaceutical cannabidiol ("CBD") formulation for the treatment of Dravet syndrome, a rare form of childhood epilepsy.

FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier.

"Coupled with our candidate's orphan drug designation in Dravet syndrome, Fast Track designation represents significant additional support of our goal of addressing the significant medical need of children suffering from this rare and catastrophic treatment-resistant form of pediatric epilepsy," said Michael L. Babich, President and Chief Executive Officer of Insys. "Rapid advancement of our pharmaceutical CBD program is a key priority for Insys, and we are pleased to be initiating clinical trials with this program in 2015. These include a Phase I/pharmacokinetic study in epilepsy patients and a Phase III clinical trial in patients suffering from Dravet syndrome and Lennox Gastaut syndrome, a second rare form of pediatric epilepsy for which our pharmaceutical CBD has received orphan drug designation."

The Company expects that Insys' new, DEA-inspected facility in Round Rock, Texas will allow the Company to manufacture ample quantities of CBD for its research and commercial plans.

About Pharmaceutical CBD
Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.

Insys' pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment. The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.

About Dravet Syndrome
Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and catastrophic form of intractable epilepsy that begins in infancy. Initial seizures are most often prolonged events and in the second year of life other seizure types begin to emerge. Development remains on track initially, with plateaus and a progressive decline typically beginning in the second year of life. Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also need to be properly treated and managed.

About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using our proprietary sublingual spray technology and our capability to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets two products, Subsys®, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. Our lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol. Insys is also developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

Subsys® is a registered trademark of Insys Therapeutics, Inc.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development of Insys' pipeline of sublingual sprays and pharmaceutical cannabinoids, expected study and program timelines and target dates related to the research and development efforts of the company and its pipeline and any expectations or results related to the Company' ability to manufacture ample quantities of CBD for its research and commercial plans and past or future meetings with governmental agencies including the FDA. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. For a description of these risks facing the company, please see the risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2013 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.