STAINES-UPON-THAMES, United
Kingdom, Aug. 22, 2018
/PRNewswire/ -- Mallinckrodt plc
(NYSE: MNK), a leading global specialty pharmaceutical company,
confirmed today that it has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) related to its New
Drug Application (NDA) for stannsoporfin.
In the letter, the Agency provided guidance regarding areas of
further evaluation for resubmitting the stannsoporfin NDA for the
treatment of newborns ≥35 weeks of gestational age with indicators
of hemolysis who are at risk of developing severe jaundice, or
hyperbilirubinemia.
"The letter from the FDA was not unexpected following the
outcome at the recent Advisory Committee meeting," said
Steven Romano, M.D., Executive
Vice President and Chief Scientific Officer. "We are evaluating
the Agency's guidance and will request a meeting with the FDA in
the coming months to discuss potential paths forward."
Until that discussion, Mallinckrodt
does not expect to make a decision related to future efforts or
investment in the developmental product.
ABOUT STANNSOPORFIN
Stannsoporfin is a heme oxygenase
inhibitor under investigation for the treatment of newborns ≥35
weeks of gestational age with indicators of hemolysis who are at
risk of developing severe jaundice, or hyperbilirubinemia. If
approved, stannsoporfin would be a first-in-class pharmacologic
treatment for severe jaundice in newborns with a novel mechanism of
action that inhibits bilirubin production at its
source.1 The safety and effectiveness of stannsoporfin
have not yet been established by the FDA.
ABOUT NEONATAL JAUNDICE
Neonatal, or newborn, jaundice
is a condition caused by the build-up of bilirubin, a yellow
substance in the blood that is formed as red blood cells break down
as part of the body's natural process.2 About three in
five babies (60 percent) have jaundice at birth, and most often it
goes away without treatment.2 However, in some cases,
the newborn is not able to clear excessive levels of bilirubin
resulting in an imbalance that leads to a condition called
hyperbilirubinemia.2,3 If severe and left untreated,
this condition may lead to neurologic complications, including
irreversible brain damage.3 The current standard of care
for treating severe jaundice is phototherapy, which targets the
excess bilirubin that has accumulated in the baby's bloodstream and
helps the body to control the bilirubin.4 However, it
does not address bilirubin production.3
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. 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
The forward-looking statements in this release
concerning stannsoporfin including expectations with regard to
future research plans 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
Investor Relations
Daniel J.
Speciale, CPA
Investor Relations and Strategy Officer
314-654-3638
daniel.speciale@mnk.com
Media
Rhonda
Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mnk.com
Meredith Fischer
Chief Public Affairs Officer
908-997-9294
meredith.fischer@mnk.com
1 InfaCare Pharmaceutical Announces the Successful
Completion of its Phase IIB Multicenter development program for
Stannsoporfin [press release]. Trevose,
PA: InfaCare Pharmaceutical Corporation. March 24, 2016.
https://www.prnewswire.com/news-releases/infacare-pharmaceutical-announces-the-successful-completion-of-its-phase-iib-multicenter-development-program-for-stannsoporfin-300241169.html.
Accessed March 20, 2018.
2 Newborn Jaundice. March of Dimes Web site.
https://www.marchofdimes.org/baby/newborn-jaundice.aspx. Updated
April 2013. Accessed March 20, 2018.
3 Bhutani VK, Johnson L, Sivieri EM. Predictive ability
of a predischarge hour-specific serum bilirubin for subsequent
significant hyperbilirubinemia in healthy term and near-term
newborns. Pediatrics.1999;103 :6– 14.
4 Muchowski KE. Evaluation and treatment of neonatal
hyperbilirubinemia. Am Fam Physician. 2014;Jun 1;89(11):873-878.
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SOURCE Mallinckrodt plc