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Mallinckrodt Receives Favorable Decision in Ofirmev (Acetaminophen) Injection Patent Case

Mallinckrodt plc (NYSE: MNK) confirmed today that the U.S. Federal Circuit Court of Appeals has affirmed findings of the U.S. District Court of Delaware in the case of Cadence Pharmaceuticals Inc. and SCR Pharmatop vs. Exela. The March 23 appeals court decision affirms that Exela infringed upon certain claims associated with both the ‘222 and ‘218 patents related to OFIRMEV® (acetaminophen) injection. The appeals court also affirmed the validity of the ’218 patent.

Mallinckrodt is pleased with the court’s decision and will continue to vigorously enforce the company’s intellectual property rights relating to OFIRMEV.

The first and only IV formulation of acetaminophen in the U.S., OFIRMEV(acetaminophen) injection anchors the company’s hospital platform. OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Mallinckrodt’s proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever. Mallinckrodt acquired the product when the company acquired Cadence in 2014.

Mallinckrodt believes that OFIRMEV has potential as part of a multi-modal approach to surgical pain management and is investing in studies to support the pharmacoeconomic value that OFIRMEV can provide in hospital settings.

Important Risk Information

RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV injection to avoid dosing errors which could result in accidental overdose and death.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur, or at the first appearance of skin rash. Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated with postsurgical pain. OFIRMEV is approved for use in patients ≥ 2 years of age. Do not exceed the recommended maximum daily dose of OFIRMEV. OFIRMEV should be administered only as a 15-minute infusion.

For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.


ABOUT MALLINCKRODT
Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology along with analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide and a commercial presence in roughly 65 countries. The company's fiscal 2014 revenue totaled $2.54 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

CONTACTS FOR MALLINCKRODT:
Rhonda Sciarra
Communications Manager
314-654-8618
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt.com

Cole Lannum or John Moten
Mallinckrodt Investor Relations

Cole Lannum
314-654-6649
cole.lannum@mallinckrodt.com

John Moten
314-654-6650
john.moten@mallinckrodt.com