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Insys Therapeutics Receives FDA Orphan Drug Designation for Liposome Entrapped Paclitaxel as a Potential Treatment for Gastric Cancer


December 9, 2014 - PHOENIX, AZ

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 Liposome Entrapped Paclitaxel Easy to Use ("LEP-ETU") candidate for the treatment of gastric cancer. LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent.

"We are pleased to have received orphan drug designation for LEP-ETU to treat gastric cancer, a devastating and difficult-to-treat disease," said Michael L. Babich, President and Chief Executive Officer. "By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate."

Insys acquired LEP-ETU during its merger in 2010 with NeoPharm.

Orphan drug designation is granted by the FDA Office of Orphan Products Development 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 upon approval, as well as certain financial incentives that can help support its development.

About Paclitaxel
Paclitaxel is an anti-microtubular network agent and is active in a broad spectrum of malignancies. To enhance its poor solubility, paclitaxel is formulated with or bound to a delivery vehicle. Taxol® is formulated with ethanol and Cremophor EL, a polyethoxylated castor oil which leads to infusion-related hypersensitivity reactions. In Abraxane®, paclitaxel is bound to albumin nano-particles.

About Gastric Cancer
Gastric cancer is the fifth most common cancer in the world, and the third-leading cause of cancer death.(1) In the U.S., it is estimated that approximately 22,000 people will be diagnosed with gastric cancer in 2014.(2)

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.

Taxol® and Abraxane® are registered trademarks of Bristol-Myers Squibb and Celgene Corporation, respectively.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential that the LEP-ETU formulation could potentially have reduced toxicity and similar or enhancing efficacy versus paclitaxel, and the development of Insys' pipeline of sublingual sprays and pharmaceutical cannabinoids. 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.

([1]) Globocan 2012 Cancer Fact Sheet. Stomach cancer estimated incidence, mortality and prevalence worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed December 8, 2014.

([1]) American Cancer Society. What are the key statistics about stomach cancer? http://www.cancer.org/Cancer/StomachCancer/DetailedGuide/stomach-cancer-key-statistics. Updated May 27, 2014. Accessed December 8, 2014.

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