STAINES-UPON-THAMES, United
Kingdom, July 12, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading
specialty pharmaceutical company, today announced the U.S. Food and
Drug Administration (FDA) has granted orphan drug designation to
MNK-1411, a long-acting formulation containing cosyntropin acetate
under investigation for the treatment of Duchenne muscular
dystrophy (DMD).
"We are pleased the FDA has granted orphan drug status to
MNK-1411 for potential treatment of DMD, a serious disease for
which there are limited treatment options," said Steven Romano, M.D., Executive Vice President
and Chief Scientific Officer. "Mallinckrodt believes MNK-1411 may have potential
to offer physicians and patients a new treatment alternative, and
this designation is an important step forward for the development
program. We continue to advance our broad clinical and regulatory
strategy in areas of high unmet medical need."
The FDA's Orphan Drug Designation program provides orphan status
to drugs and biologics that are defined as those intended for the
safe and effective treatment, diagnosis or prevention of rare
diseases or disorders that affect fewer than 200,000 people in the
U.S., or that affect more than 200,000 persons but are not expected
to recover the costs of developing and marketing a treatment drug.
The designation provides Mallinckrodt
marketing exclusivity in the U.S. for DMD for a seven-year period
following FDA approval, as well as the ability to apply for
research funding, tax credits related to certain research costs,
and a waiver of the FDA application user fee.
Mallinckrodt has completed a Phase 1
study for MNK-1411 in healthy volunteers, and the company is using
the information that was derived to determine optimal dosing for
patients in the Phase 2 trial, which should begin later this
year.
In August 2016, the FDA granted
the company's request for a Fast Track designation for its
Investigational New Drug application for MNK-1411 in the treatment
of DMD. The Fast Track designation is a process designed to
facilitate the development and expedite the review of drugs that
treat serious conditions and fill an unmet medical need.
About MNK-1411 (Cosyntropin Injection)
MNK-1411 (cosyntropin injection) is a depot formulation of
tetracosactide, a synthetic 24 amino acid melanocortin receptor
agonist. The product is approved and marketed outside of the U.S.
for certain autoimmune and inflammatory conditions, but has never
been approved for use in patients within the U.S.
About Duchenne Muscular Dystrophy (DMD)
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. 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.1
ABOUT MALLINCKRODT
Mallinckrodt is a global business
that develops, manufactures, markets and distributes specialty
pharmaceutical products and therapies. 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; and
analgesics and hemostasis products. 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.
CONTACTS
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
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
1
https://www.mda.org/disease/duchenne-muscular-dystrophy (Accessed
Aug. 21, 2016)
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SOURCE Mallinckrodt plc