Insys Addresses Questions Raised by Illinois Settlement
August 22 2017 - 6:50AM
Insys Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the Company”)
today released the following statement:
Like so many stakeholders in the healthcare
community and in the government, we share the desire to address the
serious national challenge related to the misuse and abuse of
opioids that has led to addiction and unnecessary deaths and has
caused so much pain to families and communities around the
country.
Our recent settlement with the State of Illinois,
which includes an obligation to make a $4.45 million payment,
reflects our firm commitment to take responsibility for actions by
our former employees and we affirm our continued intent to put
patients first as reflected by our actions and ethical
behavior.
With that in mind, we do not believe it is
factually accurate to state that Insys has materially contributed
to the opioid crisis in the State of Illinois or the nation.
As the healthcare community and the government seek solutions to
our national opioid crisis, it can be disheartening when this
dialogue on this extremely important topic disregards the enormous
amount of data and other facts available to all stakeholders.
We set forth below some of the relevant facts for consideration
regarding our product and the Transmucosal Immediate Release
Fentanyl (“TIRF”) class:
- By many estimates, this crisis began more than a decade and a
half ago. SUBSYS® has been available since March 2012.
- In 2016, SUBSYS® accounted for approximately 34,000
prescriptions nationally and less than 1,000 prescriptions in the
State of Illinois. In other words, in 2016, SUBSYS® was less
than 0.02% of all opioid prescriptions nationally and less than
0.01% of all opioid prescriptions in the State of
Illinois.
- These 2016 prescription numbers for SUBSYS® do not place Insys
within the top 50 manufacturers of opioids in the United
States.
- A doctor is not permitted to prescribe, a pharmacy is not
permitted to dispense, and a patient is not permitted to receive
any TIRF product, including SUBSYS®, unless each of them is
enrolled in the Food and Drug Administration (“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.
- In the National Heroin Threat Assessment Summary issued in June
2016, the Drug Enforcement Administration concluded that
“pharmaceutical fentanyl is diverted for abuse in the United States
at small levels” and recent overdose deaths from fentanyl are
“largely due to clandestinely-produced fentanyl, not diverted
pharmaceutical fentanyl.”
https://www.dea.gov/divisions/hq/2016/hq062716_attach.pdf
It is our hope that Insys can focus on
solution-based initiatives regarding the opioid crisis such as
developing alternative pain medications, increasing physician and
patient education on appropriate use of scheduled products and
coordinating on monitoring systems where there is ample evidence
that these initiatives will reduce the incidence of abuse,
addiction and overdose. We are committed to playing a
productive role in solutions as is reflected in our investment and
efforts in research and development and educational programs.
About INSYS
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.
Forward-Looking
Statements
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 Illinois or the nation 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
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