Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice

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May 03, 2018, 06:48 ET

STAINES-UPON-THAMES, United Kingdom, May 3, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today expressed disappointment that, in a joint meeting, the U.S. Food and Drug Administration's (FDA's) Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee recommended in a vote of 21 to 3 that the risk-benefit profile of stannsoporfin does not support approval for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing hyperbilirubinemia (severe jaundice).

Mallinckrodt appreciates the committees' review and discussion of stannsoporfin, and will work closely with the FDA as the review process continues. Given the outcome of today's meeting, the company is evaluating alternatives for this development program.

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.²About 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. 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
[email protected]

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
[email protected]

Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
314-654-3638
[email protected]

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.