INSYS Addresses Arizona Attorney General Complaint
Published: Sep 05, 2017
PHOENIX, Sept. 01, 2017 (GLOBE NEWSWIRE) -- Insys Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the Company”) today released the following statement:
We continue to reiterate our efforts to be part of the solution to the opioid crisis by focusing on assisting patients and developing alternative pain medications in our research and development programs. The solutions to this serious national challenge require serious commitment by, and coordination between, governmental authorities, manufacturers, prescribers, patients and other stakeholders in the healthcare community. Encompassed in our desire to bring solutions is our continuing commitment to take responsibility for actions by our former employees and ensure high standards of integrity from our current employees.
Recent statements made in connection with the Arizona Attorney General’s investigation of our Company lack context and factual accuracy, particularly as they relate to the causes of the opioid crisis in the State of Arizona. We set forth below some of the relevant facts for consideration:
- We continue to cooperate with the investigation by the Arizona Attorney General office, as we have done and will continue to do with each governmental authority.
- The allegations contained in the Arizona Attorney General’s complaint relate to former employees and physicians that are no longer associated with our Company or our speaker bureau.
- By many estimates, the national opioid crisis began more than a decade and a half ago. Our product, SUBSYS®, has been available since March 2012. In 2016, SUBSYS accounted for less than 1,450 prescriptions in the State of Arizona when compared to over 4.7 million opioid prescriptions in the State of Arizona during the same period. In other words, in 2016, SUBSYS was less than 0.03% of all opioid prescriptions in the State of Arizona.
- A doctor is not permitted to prescribe, a pharmacy is not permitted to dispense, and a patient is not permitted to receive any Transmucosal Immediate Release Fentanyl (“TIRF”) product, including SUBSYS, unless each of them is enrolled in the FDA mandatory TIRF Risk Evaluation and Mitigation Strategy (“REMS”) program. The TIRF-REMS program strives to limit the risk of abuse and misuse by restricting prescriptions to appropriate patients, preventing inappropriate conversions between medicines and educating patients, pharmacists and prescribers about potential for abuse, addiction and overdose of TIRFs, as well as the label for these products.
- Our compliance program has been under significant scrutiny for several years from governmental authorities as well as internal reviews conducted with the assistance of external experts and counsel. During this period, we have invested significant resources in establishing an effective compliance program with protocols designed to ensure compliant and ethical behavior. We recently completed a successful gap assessment into our compliance protocols and processes by an independent, global consulting firm. This assessment was voluntarily conducted with oversight from our Compliance Committee of the Board of Directors.
- Over the past several years, we have revamped our management and commercial organization. For example, 90% of the sales staff employed prior to 2014 are no longer with the organization. In addition, our management team has recently been fundamentally transformed with the replacement of key leadership positions in the commercial, operations and finance functions.
On behalf of almost 400 employees, across three facilities including a research & development laboratory and a fully functional manufacturing facility who work tirelessly to serve patients and address unmet patient medical needs, we believe it is important that public statements with respect to our Company fairly represent our continuing commitment to hold ourselves accountable and to operate with integrity.
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 proprietary sublingual 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) and SYNDROS™ (dronabinol oral solution), 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.
This press release contains forward-looking statements including regarding our (i) belief that it is not factually accurate to state that Insys has materially contributed to the opioid crisis in the State of Arizona and (ii) hope that Insys can focus on solution-based initiatives regarding the opioid crisis. These forward-looking statements are based on management's expectations and assumptions as of the date of this press 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 December 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 press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
Investor Contact: Lisa M. Wilson President 212-452-2793