INSYS Therapeutics Responds to Unsealing of Previously Filed Qui Tam Complaints and Recaps Transformation Efforts
May 15 2018 - 12:23PM
INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, today issued the following
response to the unsealing of the previously filed Qui Tam
complaints and the public release of the intervention of the
Department of Justice (DOJ) in such cases:
In December 2013, INSYS received a subpoena from the Office of
Inspector General (OIG) of the Department of Health and Human
Services (HHS), which notified the company of the commencement of
an investigation by the DOJ’s Civil Division into the company’s
sales and commercial practices and resulted in the company’s
corresponding public disclosure. As is often the case, this
four-and-a-half-year investigation has been conducted in concert
with certain whistleblower litigation that was filed under seal
prior to and during the course of the DOJ’s investigation. These
Qui Tam complaints filed against the company, along with the notice
of intervention and complaint filed by the DOJ’s Civil Division,
were unsealed yesterday.
INSYS continues to have ongoing dialogue with the DOJ regarding
this investigation. INSYS management accrued, as of Sept. 30, 2017,
an aggregate of $150,000,000 which represents the company’s current
best estimate of the minimum liability exposure which it expects to
be paid out over five years in connection with this investigation.
This ongoing dialogue has not resulted in information that would
cause the company to revise this estimate (and the related
disclosure), which was first filed in the company’s Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on Nov. 3, 2017.
As the company has documented in various public releases, today
INSYS is a completely transformed organization, with a promising
pipeline, a strong commitment to serving patients as well as an
organizational culture of high ethical standards. Throughout this
transformation, INSYS has learned from the past and remains
committed to significant innovation and investment in R&D,
which the company believes will result in improving the lives of
many patients.
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 intended to address
unmet medical needs and the clinical shortcomings of existing
commercial products. INSYS is committed to developing medications
for potentially treating addiction to opioids, opioid overdose,
epilepsy, and other disease areas with a significant unmet
need.
Forward-Looking Statements This news
release contains forward-looking statements 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, 2017 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: |
Corporate
Communications |
Investor
Relations |
|
Joe McGrath |
Jackie Marcus or Chris
Hodges |
|
INSYS Therapeutics |
Alpha IR Group |
|
480-500-3101 |
312-445-2870 |
|
jmcgrath@insysrx.com |
INSY@alpha-ir.com |
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