STAINES-UPON-THAMES, United
Kingdom, Jan. 18, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, today announced that it has
reached agreement with the U.S. Federal Trade Commission (FTC) to
resolve, without admission of wrongdoing, the previously disclosed
FTC investigation into the acquisition by Questcor Pharmaceuticals,
Inc., of Synacthen® Depot, a synthetic ACTH product, in
2013. The product became part of Mallinckrodt's portfolio with its August 2014 acquisition of Questcor.
Under the agreement, Mallinckrodt
will license the drug to a licensee, identified by the FTC as
Marathon Pharmaceuticals, LLC, to develop and pursue possible U.S.
Food and Drug Administration (FDA) approval of Synacthen Depot in
two indications – Infantile Spasms (IS) and Nephrotic Syndrome
(NS). The licensee will also acquire exclusive rights to the
Synacthen trademark in the U.S. Under the agreement, Mallinckrodt will also pay $100 million to settle claims made by the FTC and
five states1 – $90 million
of which will be paid within 10 business days, $10 million within 90 days – plus $2 million to reimburse the states' legal
fees.
Since acquiring Questcor, Mallinckrodt has cooperated fully with the FTC. A
Mallinckrodt spokesperson said, "We are
pleased with the agreement reached to resolve this legacy matter,
although we continue to strongly disagree with allegations outlined
in the FTC's complaint, believing that key claims are unsupported
and even contradicted by scientific data and market facts, and
appear to be inconsistent with the views of the FDA. Removing the
distraction of litigation enables us to focus on advancing our
increasingly diversified portfolio of medicines for the benefit of
patients. The resolution also allows us to retain the rights to
continue manufacturing and marketing Synacthen Depot to patients in
other countries around the world where we already have rights. And,
more importantly, we can continue to develop the product for all
other indications in the U.S. except IS and NS, including our
recently announced trial to explore its potential use for patients
suffering from DMD."
Mallinckrodt currently derives no
U.S. revenue from Synacthen Depot, and the resolution of this
matter will not impact Mallinckrodt's
net sales.
Synthetic ACTH products are relatively common – Synacthen Depot
and others have been on the market outside of the U.S. for years,
if not decades – and in Mallinckrodt's
view are not especially complex to either formulate or manufacture
at scale.
However, history has borne out the FTC's view that there are
"high barriers to entry" for a synthetic ACTH in the U.S. market.
Synacthen Depot has never been FDA-approved for use in the U.S. In
fact, in all the time it has been commercially available, no owner
(including the owner prior to Questcor) ever undertook U.S.
development in any indication until after the Questcor acquisition
when Mallinckrodt began preparation for
development in DMD.
The Commission further states that U.S. market entry would
require a sponsor to successfully conduct "clinical trials
necessary for FDA approval.2" This supports Mallinckrodt's publicly stated view that the
regulatory pathway for U.S. development of the product for either
IS or NS would require a sponsor to enroll and successfully
complete controlled clinical trials. This would entail convincing
patients or the parents of infant patients in fragile, high-risk
populations to forego existing approved, effective treatments and
enroll in an experimental protocol where they risk receiving less
effective treatment or no treatment at all.
In addition, recent market experience demonstrates that the time
and resources required even to explore development of a synthetic
ACTH for IS and NS can be prohibitive. In 2013, another publicly
traded company developed its own synthetic ACTH product and
announced plans to enter the U.S. market in IS and NS.
Subsequently, in a 2016 call with investors, the company
communicated that it would seek to partner with or sublicense the
product to a larger company to avoid the "time, effort and
resources" required for internal development.
INVESTOR CONFERENCE CALL
Mallinckrodt will hold a conference
call for investors on Thursday, Jan.
19 from 7:30 a.m. to 8:00 a.m.
Eastern Time. The call can be accessed in three ways:
- At the Mallinckrodt website:
http://www.mallinckrodt.com/investors.
- By telephone: For both listen-only participants and those who
wish to take part in the question-and-answer portion of the call,
the telephone dial-in number in the U.S. is (877) 359-9508. For
participants outside the U.S., the dial-in number is (224)
357-2393. Callers will need to provide the Conference ID of
50844751.
- Through an audio replay: A replay of the call will be available
beginning at 11:30 a.m. Eastern Time
on Thursday, January 19, and ending
at 11:59 p.m. Eastern Time on
February 2. Dial-in numbers for
U.S.-based participants are (855) 859-2056. Participants outside
the U.S. should use the replay dial-in number of (404) 537-3406.
All callers will be required to provide the Conference ID of
50844751.
About Synacthen Depot
Synacthen Depot is a synthetic
melanocortin peptide with 24 amino acids known as tetracosactide
that is used for the treatment of a number of conditions outside
the U.S., and Synacthen is a diagnostic formulation of the drug.
Synacthen Depot, as formulated, contains benzyl alcohol, which can
be toxic to infants.
About Duchenne Muscular Dystrophy
DMD is a genetic
disorder characterized by progressive muscle degeneration and
weakness. It is one of nine types of muscular dystrophy.
DMD is caused by an absence of dystrophin, a protein that helps
keep muscle cells intact. Symptom onset is in early childhood,
usually between ages 3 and 5. The disease primarily affects boys,
but in rare cases it can affect girls. Symptoms include muscle
weakness, which can begin as early as age 3, first affecting the
muscles of the hips, pelvic area, thighs and shoulders, and later
the skeletal (voluntary) muscles in the arms, legs and
trunk.3 Boys with DMD are typically wheelchair bound by
age 12 and do not survive past their mid-20s, when their heart and
breathing muscles begin to fail.4
About Mallinckrodt
Mallinckrodt is a global
business that develops, manufactures, markets and distributes
specialty pharmaceutical products and therapies, as well as nuclear
imaging products. 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
hemostasis products; and central nervous system drugs. The
company's core strengths include the acquisition and management of
highly regulated raw materials and specialized chemistry,
formulation and manufacturing capabilities. The company's Specialty
Brands segment includes branded medicines and its Specialty
Generics segment includes specialty generic drugs, active
pharmaceutical ingredients and external manufacturing. 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 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 document that are not strictly
historical, including statements regarding the terms of the
agreement with the FTC and the expected payment and license, future
operating results, and any other statements regarding events or
developments that we believe or anticipate 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: any
legal or regulatory challenges to the settlement; the ability of
Marathon Pharmaceuticals LLC to successfully develop and pursue FDA
approval of Synacthen Depot in IS and NS; general economic
conditions and conditions affecting the industries in which
Mallinckrodt operates; the commercial
success of Mallinckrodt's products;
Mallinckrodt's ability to protect
intellectual property rights; customer concentration; cost
containment efforts of customers, purchasing groups, third-party
payers and governmental organizations; the reimbursement practices
of a small number of public or private insurers; 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; complex reporting and payment
obligations under healthcare rebate programs; Mallinckrodt's ability to navigate price
fluctuations; and competition.
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 September 30, 2016.
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
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Daniel Yunger or Jeffrey Taufield
Kekst
212-521-4879
daniel-yunger@kekst.com
jeffrey-taufield@kekst.com
1 Alaska,
Maryland, New York, Texas, and Washington
2 Complaint, FTC, the States of Alaska, Maryland, New
York, Texas and Washington
v. Mallinckrodt ARD Inc., formerly known as Questcor
Pharmaceuticals, Inc. and Mallinckrodt PLC, paragraph 32
3
https://www.mda.org/disease/duchenne-muscular-dystrophy (Accessed August
21, 2016)
4 http://www.cureduchenne.org/aboutduchenne.html
(Accessed August 22, 2016)
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SOURCE Mallinckrodt plc