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Insys Therapeutics Responds to False and Misleading Report

PHOENIX, Dec. 04, 2015 (GLOBE NEWSWIRE) -- Insys Therapeutics, Inc. (Nasdaq:INSY) (“Insys” or “the Company”) today issued the following response to a recent report containing accusations centered on adverse events1 and diversion related to the Company’s breakthrough cancer pain drug, Subsys®.

  • Patient Safety Is Insys’s Primary Concern: Insys takes patient safety very seriously and is committed to working with the health care community, including health care providers (“HCP”), payors, pharmacies, and most importantly, patients, to help ensure the proper prescribing and use of the Company’s products. As a manufacturer of a breakthrough cancer pain drug, Insys is also committed to complying with corresponding laws and regulations, including those related to adverse event reporting.  In keeping with the U.S. Food and Drug Administration’s (“FDA”) regulations, Insys strives to report serious, unexpected adverse events to the FDA within fifteen days of learning of the event.  In accordance with this commitment, Insys has submitted to the FDA a quarterly report of adverse events related to Subsys since Insys launched this product in March of 2012.  In addition, Insys sales representatives are trained to understand and comply with the reporting requirements related to adverse events as outlined by the Federal Food, Drug & Cosmetic Act.
  • Given the Approved Indication of Subsys, It Is Not Unexpected that a Percentage of Patients Pass Away While on Subsys:  Subsys 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.  Patients must remain on around-the-clock opioids when taking Subsys.  In light of the approved indication of Subsys, it is not unexpected that a percentage of patients, many of whom are gravely ill with cancer, pass away while on Subsys; this does not establish that these patients’ deaths were caused by their use of Subsys.
  • The FDA’s Adverse Events Reporting System Presents Clear Data Around Adverse Events Concerning Subsys: Adverse events included in the FDA Adverse Event Reporting System include events that occur while a patient is using a pharmaceutical product regardless of whether they are related to, let alone caused by, the pharmaceutical product in question.  Since the launch of Subsys, the FDA’s Adverse Events Reporting System lists 244 deaths.   Of these 244 cases, three were definitively due to Subsys overdoses (one accidental, one intentional and one unknown).

    Additional data shows that of these 244 cases, 134 cases were reported by the HCP as due to the cancer for which they were prescribed Subsys. Eight of the 244 cases were reported by the HCP as not due to cancer but definitely were not due to Subsys.  83 of the 244 cases as reported were due to unknown causes as Insys was unable to obtain the information from the HCP after multiple requests. In six of the 244 cases, the HCP was uncertain whether or not the patient was actually using Subsys at the time of death due to the timing associated with the patient receiving the prescription and the actual time of death.
  • Insys Voluntarily Delayed the Launch of Subsys Until After the Transmucosal Immediate Release Fentanyl (“TIRF”) Risk Evaluation and Mitigation Strategy (“REMS”) Program Was Implemented Due to the Company’s Commitment to Ensuring the Product Would Be Used and Prescribed Appropriately: With respect to recent allegations related to the diversion of SUBSYS, in 2012, the FDA introduced the required TIRF REMS program “to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines” and “to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.”  The TIRF REMS program requires outpatients, HCPs who prescribe to outpatients, pharmacies, and distributors to enroll in the program. TIRF products can be prescribed and dispensed only after physicians and pharmacies have undergone training on the risks and benefits of such products and have enrolled in the TIRF REMS program.  This closed distribution system is intended to impede diversion of TIRF products.  Notably, although Insys obtained FDA approval of Subsys before the TIRF REMS program commenced, Insys voluntarily delayed the launch of Subsys until after the TIRF REMS program was implemented due to the Company’s commitment to ensuring the product would be used and prescribed appropriately.
  • Insys is Not Aware of the FDA  Raising Safety Concerns Regarding Subsys:  Along with other TIRF REMS product sponsors, Insys provides additional annual reports required by the FDA.  These reports provide the FDA with enhanced drug safety surveillance over the use of TIRF products.  Notably, the FDA has not requested that Insys make any changes to the Subsys label since launch due to safety concerns, nor has the FDA raised any concerns to Insys regarding the safety profile of Subsys.
  • Insys is Committed to Patient Safety and the Recent Allegations are Disingenuous: Insys is committed to patient safety and strives to ensure patient access to Subsys.  While Insys does not generally comment on inaccurate and false statements made regarding the Company and its products, Insys finds the recent false accusations and complete misrepresentations of publicly available data concerning the number of deaths associated with the use of Subsys, a product that is helping many patients suffering from breakthrough cancer pain, both shameful and disingenuous, particularly in light of the biased agenda held by the individuals who made these misrepresentations.

1 FDA regulations define “adverse drug experiences,” to include “adverse event[s] associated with the use of a drug in humans, whether or not considered drug related, including . . . [a]n adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.” (21 C.F.R. Part 314.80.)

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 proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets one product, Subsys® (fentanyl sublingual spray). The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for Syndros® (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

Subsys® and Syndros® are registered trademarks of Insys Therapeutics, Inc.

Forward-Looking Statements
This release contains forward-looking statements. 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, 2014 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.

Contact:

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

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