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INSYS Therapeutics Receives FDA Orphan Drug Designation For Its Pharmaceutical Cannabidiol As A Potential Treatment For Glioblastoma Multiforme


8/25/2014 10:48:04 AM

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PHOENIX, AZ--(Marketwired - August 25, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY), a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumor in humans.

"We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients," said Michael L. Babich, President and Chief Executive Officer.

In addition to receiving ODD, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI's patent rights related to the usage of cannabinoids for the treatment of GBM.

In concert with the aforementioned exclusive licensing agreement, Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment. "Based on previous research conducted with CBD to treat brain tumors, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans," said Dr. McAllister.

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility, located in Round Rock, Texas. The company recently submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient and believes that it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

Insys was previously granted ODD to its pharmaceutical CBD for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids. Insys intends to pursue orphan drug designation for other indications that may qualify.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as certain financial incentives that can help support its development.

About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumors and one of the most aggressive forms of cancer. The aggressive behavior of GBM is secondary to its high invasiveness and proliferation rate as well as to its high resistance to standard chemotherapy and radiotherapy. Current therapeutic strategies for the treatment of GBM fail to demonstrate adequate efficacy and/or are generally palliative. Despite decades of research into its treatment, prognosis remains poor, with median overall survival of 12 to 14 months. Therefore it is important to identify new treatment modalities to improve therapeutic efficacy and enhance GBM chemosensitivity.

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 its proprietary sublingual spray technology and its capability to develop pharmaceutical cannabinoids, the company addresses the clinical shortcomings of existing commercial products. The company currently markets two products, Subsys, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. The company submitted a New Drug Application (NDA) to the FDA for an oral liquid formulation of Dronabinol in August 2014 and believes the oral solution formulation has distinct advantages over the current formulation of dronabinol in a soft gel capsule. The company is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development of Insys' pipeline of sublingual sprays and pharmaceutical cannabinoids, the ability of Insys to advance development of a product related to CBD for GBM and offering a potential cure for patients, Insys' belief that it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities, and Insys' belief that its oral solution formulation 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.




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