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Insys Therapeutics Submits NDA for Its New Oral Formulation of Dronabinol

PHOENIX, AZ -- (Marketwired) -- 08/12/14 -- Insys Therapeutics, Inc. (NASDAQ: INSY), a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol (THC).

"The NDA submission for Dronabinol Oral Solution, our lead pipeline candidate, marks a significant milestone for us in the advancement of our pharmaceutical cannabinoid program. Based on early research, we believe Dronabinol Oral Solution has the potential to offer a treatment option with distinct advantages over generic dronabinol capsules including a faster rate of absorption, more consistent blood levels, and the ability to titrate to effect," said Michael L. Babich, President and Chief Executive Officer.

"We believe Dronabinol Oral Solution can become an important new option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS. We are committed to advancing research and development of cannabinoid therapies to provide physicians and patients with pure, consistent and controlled pharmaceutical options to address unmet medical needs."

"With 70 percent of generic dronabinol prescriptions written by approximately 8,000 healthcare providers, and prescriptions growing organically at a rate of four percent annually, the approval of this novel formulation would create an opportunity to satisfy a growing unmet medical need. Insys intends to scale its sales force to adequately cover 45 percent of the dronabinol prescribers treating people with AIDS as well as the remaining 55 percent treating CINV," Babich added.

"Currently the generic market for Marinol is estimated at $150 million and our product would be the only branded option competing in this space. Once launched, we believe we have the potential to capture significant market share using the same strategy that enabled Subsys to successfully penetrate the TIRF market," Babich concluded.

Upon completion of the Phase III trial:

  • Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC,
  • All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels,
  • The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC.

Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.

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 its pipeline of sublingual sprays and pharmaceutical cannabinoids; the distinct advantages Dronabinol Oral Solution potentially offers over generic dronabinol capsules; our belief as to the uses of Dronabinol Oral Solution; and estimations of the generic market for Marinol and our ability to scale our sales force to adequately cover the market. 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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