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Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by FDA

Mallinckrodt’s MNK-155, a hydrocodone/acetaminophen extended-release combination, accepted for filing by U.S. Food and Drug Administration

U.S. Patent Office notice of allowance covers the product’s composition and release profile

DUBLIN--(BUSINESS WIRE)--May 28, 2014-- Mallinckrodt plc (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-155. MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate.

The NDA submission was based on positive efficacy results in a Phase 3 clinical trial, in addition to a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155.

Mallinckrodt recently received notice of allowance from the United States Patent and Trademark Office related to composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics for MNK-155. The release profile of MNK-155 combines Mallinckrodt-proprietary technology and Depomed’s advanced Acuform® drug delivery technology. Between the Mallinckrodt and Depomed patent families, Mallinckrodt believes MNK-155 will have strong patent protection for its novel features.

“Hydrocodone combination products are the most frequently prescribed medications in the country, according to recent IMS data,” said Dr. Mario Saltarelli, Chief Science Officer, Mallinckrodt. “But we believe that there’s a very real need to pause and consider whether this familiar combination can be delivered to patients in a way that can last longer than 4-6 hours. We’re pleased that the FDA has accepted the MNK-155 New Drug Application filing for review, as the product may fill an important need in the marketplace. Furthermore, our allowed patent claims, which include claims to the product’s release profile, highlight our ability to effectively leverage our core formulation capabilities and partnerships.”

About Mallinckrodt

Mallinckrodt is a global specialty pharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. 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 Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, 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 approximately 65 countries. The company’s fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

FORWARD-LOOKING STATEMENTS

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting our business and our pending merger with Questcor. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration, our ability to obtain and/or timely transport molybdenum-99 to our technetium-99m generator production facilities, customer concentration, cost-containment efforts of customers, purchasing groups, third-party payors and governmental organizations, our ability to successfully develop or commercialize new products, our ability to protect intellectual property rights, competition, our ability to complete our pending merger with Questcor Pharmaceuticals, our ability to integrate acquisitions of technology, products and businesses, product liability losses and other litigation liability, the reimbursement practices of a small number of large public or private issuers, complex reporting and payment obligation under healthcare rebate programs, changes in laws and regulations, conducting business internationally, foreign exchange rates, material health, safety and environmental liabilities, litigation and violations, information technology infrastructure and restructuring activities. These and other factors are identified and described in more detail in the “Risk Factors” section of Mallinckrodt’s Annual Report on Form 10-K for the fiscal year ended September 27, 2013 and Quarterly Report on Form 10-Q for the quarterly periods ended December 27, 2013 and March 28, 2014. Additional consideration should be given to the "”Risk Factor" sections of the SEC filings of Cadence Pharmaceuticals, Inc., which was acquired by Mallinckrodt on March 19, 2014, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2013; and Questcor Pharmaceuticals, Inc. SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014. We disclaim any obligation to update these forward-looking statements other than as required by law.

Source: Mallinckrodt plc

Mallinckrodt plc
Lynn Phillips, 314-654-3263
Manager, Communications
lynn.phillips@mallinckrodt.com
or
Meredith Fischer, 314-654-3318
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com
or
John Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com