Mallinckrodt New Drug Application Granted Priority Review by FDA

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Mallinckrodt New Drug Application Granted Priority Review by FDA

Mallinckrodt's MNK-795 - controlled-release oxycodone/acetaminophen combination accepted for filing by U.S. Food and Drug Administration

HAZELWOOD, Mo.--(BUSINESS WIRE)-- Mallinckrodt (NYS: MNK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. FDA priority review is a defined NDA review process used for drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications.

If approved, MNK-795 would be a controlled-release oxycodone and acetaminophen combination medication that has immediate and extended release components. The dosage form was designed using Depomed's advanced Acuform® drug delivery technology with tamper-resistant properties.

"Despite the number of available pain medications, patients continue to experience unresolved pain and lack treatment options that offer fast-acting and long-lasting relief. We are pleased the FDA granted priority review designation," said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt Pharmaceuticals. "Mallinckrodt has unique capabilities in complex formulations such as MNK-795 and this marks an important milestone for us as our first NDA acceptance as an independent specialty pharmaceutical company."

Mallinckrodt's submission is based on data from a comprehensive clinical trial program for MNK-795 that included 14 clinical studies with 1,281 patients. The studies evaluated pharmacokinetics, efficacy, safety and abuse liability.

About Mallinckrodt

Mallinckrodt is a leading global specialty pharmaceuticals 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 the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide with direct sales in roughly 50 countries and distribution in approximately 40 countries. The company's 2012 revenue totaled $2.1 billion. To learn more about Mallinckrodt, visit


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.

Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations

KEYWORDS:   United States  North America  Missouri


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