SOURCE: INSYS Therapeutics

Insys Therapeutics

October 15, 2014 16:31 ET

Insys Receives DEA Approval to Produce Pharmaceutical Cannabidiol -- Updates Status of Its Cannabinoid Program

PHOENIX, AZ--(Marketwired - Oct 15, 2014) -  Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that its Food and Drug Administration (FDA) inspected and Drug Enforcement Agency (DEA) approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol (CBD). The Company has also been granted a quota to produce 15kg of CBD in 2014 and expects a larger quota in 2015 for its continued clinical studies. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned.

Insys held a pre-IND meeting with the FDA in September 2014 regarding its development program for CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome (LGS), two rare forms of pediatric epilepsy. Insys projects to file an IND in December 2014 for these indications. 

"We are excited to initiate our clinical development of CBD in these pediatric epilepsy patients, for whom current treatments are insufficient. We plan to dose our first human subject in the first quarter of 2015 in a Phase I setting," said Michael L. Babich, President and Chief Executive Officer of Insys.

"Numerous investigators are waiting to receive our finished pharmaceutical dosage product to study several other potential indications for CBD. With DEA approval to manufacture CBD in hand, we are now in a position to supply product to these investigators," Babich indicated. 

Babich also noted that Insys has compared its pharmaceutical CBD, which is synthetically produced, with plant-derived CBD obtained from the National Institute on Drug Abuse (NIDA), and found both materials contain an identical chemical structure. "We are pleased that testing in our laboratories has confirmed our long-standing belief that our pharmaceutical CBD is the chemical structure of plant-derived CBD and we believe our purity levels will provide consistent material in the clinical programs," Babich concluded. 

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. The Company's lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in a soft gel capsule. Insys is 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 Insys' pharmaceutical CBD development program, including timing of the anticipated NDA submission and initiation of clinical trials, the ability of Insys to advance development of a product related to CBD for Dravet Syndrome and LGS, the ability of Insys to provide adequate quantities of CBD sufficient to pursue its CBD development program and Insys' belief that Dronabinol Oral Solution has distinct advantages over the current formulation of dronabinol in a soft gel capsule. 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.