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Mallinckrodt Pharmaceuticals Announces Completion of MNK-155 Clinical Trials

MNK-155 studies evaluated pharmacokinetics, efficacy, safety and abuse liability

ST. LOUIS--(BUSINESS WIRE)--Dec. 12, 2013-- Mallinckrodt (NYSE: MNK) today reported positive efficacy results in the Phase 3 clinical trial for MNK-155, 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. MNK-155 met the primary endpoint in this study.

Mallinckrodt also completed a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155. These data, including the Phase 3 efficacy data, will be presented at a future medical meeting and will be submitted to the U.S. Food and Drug Administration (FDA) in a New Drug Application (NDA) for MNK-155. The NDA is expected to be submitted in the second half of fiscal 2014.

“Despite the number of available pain medications, some patients continue to experience unresolved pain. Our goal is to provide another treatment option for the management of moderate to moderately severe acute pain for patients and their physicians,” said Mario Saltarelli, Chief Science Officer, Mallinckrodt. “We are encouraged by these findings and look forward to submitting these results to the FDA as part of our application.”

The Phase 3 efficacy study evaluated the efficacy and safety of MNK-155 in a post-surgical acute pain model. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID₄₈) compared to placebo. The most common adverse events associated with the use of MNK-155 were nausea (25%), vomiting, dizziness, headache, constipation and somnolence (sleepiness).

About Mallinckrodt

Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. The company’s Specialty Pharmaceuticals segment includes branded and 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 commercial presence in roughly 70 countries. The company’s 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. 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 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 and information technology infrastructure. These and other factors are identified and described in more detail in the “Risk Factors” section of the Form 10 Registration Statement, as amended. We disclaim any obligation to update these forward-looking statements other than as required by law.

Source: Mallinckrodt

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