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Insys Therapeutics, Inc. Issues Statement

PHOENIX, Nov. 23, 2015 (GLOBE NEWSWIRE) -- Insys Therapeutics, Inc. (“Insys” or “the Company”) (NASDAQ:INSY) today issued the following statement:

INTRODUCTION

Insys is committed to developing products for the supportive care of patients through the use of its drug delivery technologies.  Insys takes patient safety very seriously and is committed to working with the health care community, including health care providers, or HCPs, payors, pharmacies, and most importantly, patients to help ensure the proper prescribing and use of its products. 

Insys is the manufacturer of Subsys®, the first and only fentanyl sublingual spray.  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.  Please see “Important Safety Information About Subsys” below.  Subsys belongs to a class of opioids known as Transmucosal Immediate Release Fentanyl products, or TIRF, the first of which was introduced over 15 years ago. Insys began to sell Subsys on March 26, 2012.  It’s important to note that Subsys was the sixth product in the TIRF class to enter the market.  At the time of the launch of Subsys, at least two of these TIRF products had been in the market for over 5 years.

TIRF REMS PROGRAM

Under the TIRF Risk Evaluation and Mitigation Strategy, or REMS, program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must 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.  As stated on the website for the TIRF REMS program, in 2012, the FDA introduced this required 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.” Insys voluntarily delayed the launch of Subsys until after the TIRF REMS program was implemented even though it had obtained FDA approval prior to the TIRF REMS program commencement.
             
Insys believes that this FDA mandated TIRF REMS program has resulted in controls that strive to decrease abuse and misuse of TIRF products and provide the FDA with valuable information to monitor the prescribing of TIRF products.  Insys believes that other opioids, such as oxycodone and hydrocodone, without a FDA mandated REMS program are more likely to be abused and represent a significantly higher number of prescriptions than the TIRF class (see Figure 1 below).

Insys has a compliance program in place with protocols that are designed to ensure its sales and marketing practices comply with applicable laws. Since the commercial launch of Subsys, Insys has focused its educational and promotional activities on REMS-enrolled providers.  Insys’ sales representatives are only permitted to call on REMS-enrolled HCPs, oncologists or individuals who have previously prescribed TIRF products and Insys only utilizes REMS-enrolled physicians as promotional speakers (subject to additional company mandated controls). 

Based on its interactions with patients and prescribers, Insys believes that the success of Subsys is directly attributable to the clinical benefits of its product.  The sublingual spray technology utilized for Subsys is a unique vehicle for delivery of medicines where fast onset of action and convenience is needed. Characteristics unique to the device lend themselves to ensuring that the medicine is applied through a fine mist to a large section of the submucosal area. Furthermore, since the product is delivered sublingually (i.e., under the tongue), the thin submucosa layer of the tongue lends itself to fast absorption of the medicine.  Ultimately, Subsys offers key differences from the competitors in this TIRF class:

  • Subsys is the only product in the class that may provide pain relief in as little as five minutes as compared to 10-15 minutes
  • In clinical trials comparing the product to the fentanyl citrate lozenge, it was established that Subsys had better bioavailability as compared to the lozenge
  • Subsys is also delivered with ease by activating the device containing Subsys

While Subsys’s share of the TIRF market has grown significantly since it was launched in 2012, the overall total number of TIRF prescriptions in 2014 was only slightly higher than the total number of TIRF prescriptions in the year of the launch of Subsys (2012) and was actually materially lower than the total number of prescriptions in the year prior to the launch of Subsys and the TIRF REMS program (2011). Given these facts and other relevant information, Insys believes that existing data strongly support that prescribing decisions have been driven primarily by the clinical attributes of Subsys and its market share gains have come from patients and HCP’s switching to Subsys from other TIRF products.

According to data available from Source Health Analytics, the total number of opioid prescriptions written in the past 12 months were over 190 million.  TIRF products represents less than 0.07% of all opioid prescriptions.  Furthermore, Subsys represents only 0.03% of all opioid prescriptions, or approximately 56,000 of the 190 million opioid prescriptions written in the past 12 months. Figure 1 below illustrates these data.

Figure 1
http://www.globenewswire.com/NewsRoom/AttachmentNg/f907d112-1b51-4a24-a744-1093325aae9f

The REMS program for TIRF products to which Subsys belongs, does not exist for most abused opioids like hydrocodone and oxycodone. The Company believes that the lack of a REMS program may contribute to the abuse of these products.* Also, as is evident (from Figure 1 above), TIRF product scripts are only a fraction of all opioids.  Insys strives to comply with all FDA and other regulatory adverse event reporting requirements, and has had minimal reports of Subsys abuse since launch.

OREGON SETTLEMENT

As previously disclosed by Insys, in connection with the investigation by the Oregon Department of Justice, or ODOJ, the Company has entered into a settlement agreement with the ODOJ referred to as an Assurance of Voluntary Compliance, or AVC.  Below the Company clarifies certain facts related to the AVC and the settlement:

  • This AVC expressly provides that Insys did not admit any violation of law or regulation
  • Despite its defenses to the claims asserted, Insys believed it was in its best interests to settle the litigation in order to avoid the further expense, inconvenience and burden of the Oregon investigation and the diversion of personnel and resources and to avoid the risks inherent in uncertain complex litigation.
  • The AVC requires Insys to maintain certain controls and processes around its promotional and sales activity related to Subsys in Oregon.  The sales and marketing controls and processes contained in the AVC were practices previously implemented and followed by Insys (and Oregon did not require Insys to alter any of its current sales and market controls and processes in connection with the settlement).
  • $567,000 of the $1.1 million monetary payments made in connection with this settlement went to a non-profit or governmental organization(s) that work to prevent abuse, misuse, or misprescribing of opioid drugs or that provide services intended to remediate problems relating to misuse, abuse, or misprescribing of opioid drugs.  

PIPELINE PRODUCTS

The Company’s unique sublingual technology is being utilized by Insys in a variety of other pipeline products some of which seek to address the concern of opioid abuse including: (a) the development of a naloxone sublingual spray candidate for potential use in rescuing patients in opioid overdose (b) the development of a buprenorphine sublingual spray candidate for potential use in acute and chronic pain, and (c) the development of a buprenorphine/naloxone sublingual spray candidate for potential use in managing opioid addiction.

The Company realizes that the cancer patient population is underserved, and in addition to the spray candidates mentioned above, hopes to introduce Syndros®, its proprietary dronabinol oral solution post FDA approval. This product will potentially be indicated for treating chemotherapy induced nausea and vomiting (CINV) and for appetite stimulation in AIDS patients. Furthermore the Company is undertaking research in a liposomal encapsulated paclitaxel product candidate in gastric and ovarian cancers. Cannabidiol is also being researched by the Company for a spectrum of indications including epilepsy and a wide variety of unmet needs. Insys plans to spend approximately $100 million in 2016 in developing all of the above projects.

*Both Hydrocodone and Oxycodone now have REMS programs in place.  Zohydro ER (hydrocodone) was approved in 2012 with a REMS and OxyContin controlled-release was approved in 2010 with a REMS.

Important Safety Information About Subsys

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.  The most serious adverse reactions associated with all opioids including Subsys are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock.  The most common adverse reaction leading to discontinuation of Subsys was nausea.  There were also adverse reactions of abdominal distention, anorexia, confusional state, disorientation, somnolence, and constipation. 

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 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 press release contains forward-looking statements including regarding our (i) beliefs and expectations involving our compliance program, and (ii) expectations for our research and development and clinical efforts, including statements related to our plans for R&D expenditures and belief that our Dronabinol Oral Solution formulation, which we expect to brand as Syndros®, has distinct advantages over the current formulation of dronabinol in soft gel capsule. 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.

Investor and Media Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
Phone: 212-452-2793
Email: [email protected]

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Insys Therapeutics, Inc.