STAINES-UPON-THAMES, United Kingdom, March 11, 2020 /PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK) ("Mallinckrodt" or
the "Company") today announced that New
York State Attorney General Letitia
James has joined 47 other state and U.S. Territory Attorneys
General in supporting the previously announced proposed global
opioid settlement with Mallinckrodt and
related entities.
As announced on February 25, 2020,
the Company and its specialty generics-focused subsidiaries
Mallinckrodt LLC, SpecGx LLC and certain other affiliates
(collectively, "Specialty Generics") have reached an agreement in
principle on the terms of a global settlement that would resolve
all opioid-related claims against the Company, Specialty Generics,
and the Company's other subsidiaries. The agreement in principle
was reached with a court-appointed plaintiffs' executive committee
representing the interests of thousands of plaintiffs in the opioid
multidistrict litigation1 and, with the addition of the
New York State Attorney General,
is supported by a broad-based group of 48 state and U.S. Territory
Attorneys General.
In connection with New York
State's support of the proposed settlement, on March 9, 2020, the State of New York and Suffolk County, together with Mallinckrodt LLC
and SpecGx LLC, jointly filed a motion to sever, or remove,
Mallinckrodt LLC and SpecGx LLC from the New York State opioid trial, which, as of
March 10, 2020, has been postponed
indefinitely due to the coronavirus. Nassau County opposed the motion. The motion
to sever Mallinckrodt LLC and SpecGx LLC from the New York State trial is currently pending
before the Supreme Court of New
York, County of Suffolk.
Mark Casey, Executive Vice
President and Chief Legal Officer of Mallinckrodt said, "We are pleased that
New York State has joined the
already 47 states and territories in supporting Mallinckrodt's proposed global opioid settlement,
and view their support as an important step toward completing the
settlement. We remain committed to satisfying the terms of the
agreement in principle and continuing to work toward achieving that
objective."
A copy of the term sheet outlining the terms of the proposed
settlement, including the conditions to the effectiveness of the
settlement, was filed as an exhibit to a Current Report on Form 8-K
Mallinckrodt filed with the U.S. Securities and Exchange Commission
on February 25, 2020.
For additional information about the proposed global opioid
settlement, please visit www.advancingmnk.com.
ABOUT MALLINCKRODT
Mallinckrodt is a global
business consisting of multiple wholly owned subsidiaries that
develop, manufacture, market and distribute specialty
pharmaceutical products and therapies. The company's
Specialty Brands reportable segment's areas of focus include
autoimmune and rare diseases in specialty areas like neurology,
rheumatology, nephrology, pulmonology and ophthalmology;
immunotherapy and neonatal respiratory critical care therapies;
analgesics and gastrointestinal products. Its Specialty
Generics reportable segment includes specialty generic drugs and
active pharmaceutical ingredients. To learn more
about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution
of important company information, such as press releases, investor
presentations and other financial information. It also uses
its website to expedite public access to time-critical information
regarding the company in advance of or in lieu of distributing a
press release or a filing with the U.S. Securities and Exchange
Commission (SEC) disclosing the same information. Therefore,
investors should look to the Investor Relations page of the website
for important and time-critical information. Visitors to the
website can also register to receive automatic e-mail and other
notifications alerting them when new information is made available
on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
Statements in this press release that are not strictly
historical, including statements regarding the proposed global
opioid settlement, and any other statements regarding events or
developments the Company believes or anticipates will or may occur
in the future, may be "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual
events to differ materially from those suggested or indicated by
such forward-looking statements and you should not place undue
reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things:
governmental investigations and inquiries, regulatory actions and
lawsuits brought against Mallinckrodt
by government agencies and private parties with respect to its
historical commercialization of opioids, including the non-binding
agreement in principle regarding terms and conditions of a global
settlement to resolve all current and future opioid-related claims;
scrutiny from governments, legislative bodies and enforcement
agencies related to sales, marketing and pricing practices; pricing
pressure on certain of Mallinckrodt's
products due to legal changes or changes in insurers' reimbursement
practices resulting from recent increased public scrutiny of
healthcare and pharmaceutical costs; the reimbursement practices of
governmental health administration authorities, private health
coverage insurers and other third-party payers; complex reporting
and payment obligations under the Medicare and Medicaid rebate
programs and other governmental purchasing and rebate programs;
cost containment efforts of customers, purchasing groups,
third-party payers and governmental organizations; changes in or
failure to comply with relevant laws and regulations; Mallinckrodt's and its partners' ability to
successfully develop or commercialize new products or expand
commercial opportunities; Mallinckrodt's ability to navigate price
fluctuations; competition; Mallinckrodt's and its partners' ability to protect
intellectual property rights; limited clinical trial data for
Acthar Gel; clinical studies and related regulatory processes;
product liability losses and other litigation liability; material
health, safety and environmental liabilities; potential
indemnification liabilities to Covidien pursuant to the separation
and distribution agreement; business development activities;
retention of key personnel; the effectiveness of information
technology infrastructure including cybersecurity and data leakage
risks; customer concentration; Mallinckrodt's reliance on certain individual
products that are material to its financial performance;
Mallinckrodt's ability to receive
procurement and production quotas granted by the U.S. Drug
Enforcement Administration; complex manufacturing processes;
conducting business internationally; Mallinckrodt's ability to achieve expected benefits
from restructuring activities; Mallinckrodt's significant levels of intangible
assets and related impairment testing; labor and employment laws
and regulations; natural disasters or other catastrophic events;
Mallinckrodt's substantial indebtedness
and its ability to generate sufficient cash to reduce its
indebtedness; the proposed refinancing of certain near-term debt
maturities; future changes to U.S. and foreign tax laws or
the impact of disputes with governmental tax authorities; and the
impact of Irish laws.
These and other factors are identified and described in more
detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for
the fiscal year ended December 27,
2019. The forward-looking statements made herein speak only
as of the date hereof and Mallinckrodt
does not assume any obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events and developments or otherwise, except as required by
law.
CONTACTS
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Media
Michael Freitag / Aaron
Palash / Aura Reinhard
Joele Frank, Wilkinson Brimmer
Katcher
(212) 355-4449
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other
brands are trademarks of a Mallinckrodt
company or their respective owners. © 2020
Mallinckrodt. 03/20
1 Captioned In re National Prescription Opiate
Litigation, Case No. 17-md-2804 (N.D. Ohio).
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SOURCE Mallinckrodt plc