STAINES-UPON-THAMES, United
Kingdom, Feb. 23, 2018
/PRNewswire/ -- Mallinckrodt plc (NYSE:
MNK), a leading global specialty pharmaceutical company, today
announced the U.S. Food and Drug Administration (FDA) has accepted
its New Drug Application (NDA) seeking approval of its
recently acquired developmental product stannsoporfin. If approved,
the drug is expected to become the first and only pharmacologic
option in the U.S. indicated for treatment of neonates at risk for
developing severe hyperbilirubinemia, or severe jaundice.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has
set its action date to respond to the NDA as August 22, 2018. The agency previously
granted its Fast Track status to stannsoporfin. The Fast Track
designation is a process designed to facilitate the development,
and expedite the review of drugs to treat serious conditions and
fill an unmet medical need1.
"We are pleased the FDA has accepted our application," said
Steve Romano, M.D., Chief
Scientific Officer and Executive Vice President of Mallinckrodt. "We look forward to working with
the agency in the coming months on the potential approval of
stannsoporfin as a new treatment option for thousands of infants at
risk for developing severe jaundice who have an unmet medical
need."
ABOUT SEVERE HYPERBILIRUBINEMIA AND
STANNSOPORFIN
Neonatal jaundice is a common condition in
neonates that is associated with the yellowing of the skin and the
whites of the eyes, typically in the first few days after birth. In
most cases, it does not require treatment; however, elevated
bilirubin levels in the blood (hyperbilirubinemia) can be toxic and
may potentially lead to neurologic complications, including
encephalopathy or irreversible brain damage. Currently,
phototherapy is used to help the body clear bilirubin and bring
levels down.
Stannsoporfin is a heme oxygenase inhibitor under investigation
for its potential to reduce the production of bilirubin in infants
at risk for severe neonatal jaundice. The safety and effectiveness
of stannsoporfin have not yet been established by the FDA.
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; analgesics and
gastrointestinal 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 (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
This release includes forward-looking statements
concerning stannsoporfin including expectations with regard to
future regulatory actions and potential impact on patients. The
statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements:
satisfaction of regulatory and other requirements; actions of
regulatory bodies and other governmental authorities; changes in
laws and regulations; issues with product quality, manufacturing or
supply, or patient safety issues; future commercialization efforts;
and other risks identified and described in more detail in the
"Risk Factors" section of Mallinckrodt's most recent Annual Report on Form
10-K and other filings with the SEC, all of which are available on
its website. 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
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
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1 https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
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SOURCE Mallinckrodt plc