INSYS Therapeutics Addresses New Jersey Complaint

INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the Company”) today released the following statement:

We would like to reiterate that we continue to work with relevant authorities to resolve issues related to inappropriate actions taken by some of our former employees. Accordingly, we have taken a series of major actions to prevent the mistakes of the past from happening in the future.

With respect to the complaint filed by the New Jersey Attorney General this week, SUBSYS® (fentanyl sublingual spray) represented about 0.02 percent of the opioid prescriptions written in the United States in 2016, consistent with the numbers in N.J., placing INSYS below the top 50 manufacturers of opioids in the nation.

In addition, the company is under new management and has replaced 90 percent of the original sales force and commercial organization. While understandable, it’s disingenuous to repeatedly demonize a company that has made a firm and sincere commitment and is taking all the necessary steps to conduct business according to high ethical standards. It’s also unfair to the company’s current employees, most of whom are new to INSYS and had no involvement in the past misdeeds.

We employ nearly 400 people, including many scientists, researchers and physicians, and have invested more than $250 million over the past five years in R&D, which promises to deliver new treatment options for unmet patient needs, including:

• synthetic cannabinoids for refractory pediatric epilepsy, Prader-Willi syndrome, anorexia in cancer patients and agitation in Alzheimer’s disease;
• intranasal formulations of epinephrine, naloxone and rizatriptan for anaphylaxis reaction, opioid overdose and migraine, respectively; and
• sublingual formulations of buprenorphine and a combination of buprenorphine and naloxone for moderate-to-severe acute pain and opioid dependence, respectively.

We are determined to continue making a positive contribution to patients and to resolve the issues of the past, as we have demonstrated in several other states. Our vision is to improve the quality of patient care by building a specialty pharmaceutical company focused on cannabinoids and novel drug delivery systems that address unmet patient needs.

About INSYSINSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS currently markets SUBSYS® (fentanyl sublingual spray), CII, and SYNDROS® (dronabinol) oral solution, CII, a proprietary, orally administered liquid formulation of dronabinol. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.

SUBSYS® and SYNDROS® are trademarks of INSYS Development Company, Inc., a subsidiary of INSYS Therapeutics, Inc.

NOTE: All trademarks and registered trademarks are the property of their respective owners.

Forward-Looking Statements This news release contains forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; 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. These factors include, but are not limited to, 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 Dec. 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

CONTACT:

Media RelationsJoe McGrathSenior Director, Corporate CommunicationsINSYS [e-mail]

Investor RelationsJackie Marcus or Chris HodgesAlpha IR Group312-445-2870 [e-mail]