Insys Therapeutics Announces Listing of U.S. Patents Covering SUBSYS(R) Use and Formulation in FDA's Orange Book

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PHOENIX, AZ--(Marketwired - Aug 27, 2013) - Insys Therapeutics, Inc. (NASDAQ: INSY), a pharmaceutical company focused on commercial-stage specialty pharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has listed U.S. Patent Nos. 8,486,972 ('972 patent) and 8,486,973 ('973 patent) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Both of these patents cover SUBSYS brand fentanyl sold by Insys and will expire no sooner than 2027. The '972 patent covers the SUBSYS sublingual fentanyl spray formulation, while the '973 patent covers the use of the SUBSYS sublingual fentanyl spray for the treatment of pain. The proprietary formulation of the '972 patent is useful for delivering fentanyl directly to the sublingual mucosa to achieve appreciable plasma concentration levels within 5 minutes. This unique formulation differs from other fentanyl formulations in that it is readily absorbed bringing quick and effective pain relief to the patient without the need for injections or IVs. The methods included in the '973 patent cover the treatment of a patient suffering from pain by administration of the formulation described in the '972 patent.

Important SUBSYS Safety Information

  • Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
  • Keep out of reach of children.
  • Use with CYP3A4 inhibitors may cause fatal respiratory depression.
  • When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS.
  • When dispensing, do not substitute with any other fentanyl products.
  • Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
  • SUBSYS is available only through a restricted program called the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

About SUBSYS (fentanyl sublingual spray)
SUBSYS is a sublingual spray formulation of free fentanyl in a novel single unit-dose delivery device which disperses a fine mist over a broad sublingual area. In clinical trials, SUBSYS achieved a mean absolute bioavailability of fentanyl of 76% and achieved summed pain intensity differences at 30 minutes post treatment, as well as other efficacy assessments 5, 10, 15, 45, and 60 minutes post treatment. SUBSYS is available in 100 mcg through 1600 mcg doses, and can be administered in seconds. SUBSYS was FDA approved in January 2012 and is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Full prescribing information is available at subsysspray.com.

About Insys Therapeutics, Inc.
Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products, with a focus on utilizing its proprietary formulation technologies to address the clinical shortcomings of existing commercial pharmaceutical products. The company has two marketed products including Subsys, a proprietary sublingual fentanyl spray for breakthrough pain in opioid-tolerant cancer patients. Insys markets Subsys through its incentive-based, cost-efficient commercial sales force. The company's lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol, which would be its second branded supportive care product, if approved.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the on-going commercialization of Insys' products and development of its product candidates and the company's positioning to build on its supportive care franchise and deliver value to stockholders. 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. These factors include, but are not limited to risks regarding Insys' ability to commercialize products successfully, Insys' ability to successfully manage its commercial relationships and sales infrastructure, compliance with post-approval regulatory requirements and the company's need to potentially obtain additional financing to successfully commercialize or further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the risk factors described in the company's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to update or revise these statements, except as may be required by law.

Contact:
Company
Darryl S. Baker
Chief Financial Officer
Insys Therapeutics, Inc.
(602) 910-2617

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