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FDA Extends Review of Mallinckrodt Pharmaceuticals (MNK)' New Drug Application For XARTEMIS™ XR (Oxycodone Hydrochloride And Acetaminophen) Extended-Release Tablets (CII)


11/25/2013 7:29:02 AM

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U.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)

ST. LOUIS--(BUSINESS WIRE)-- Mallinckrodt (MNK) today announced that the U.S. Food and Drug Administration (FDA) extended the review of the New Drug Application (NDA) for investigational compound XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII). XARTEMIS XR, previously known as MNK-795, was studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The three-month extension from the FDA is in response to additional data submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will continue discussions regarding labeling as part of the application review throughout this period.

“If approved, we believe that XARTEMIS XR could provide an important new option as an extended-release treatment for patients with acute pain,” said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt. “As a leader in pain management, Mallinckrodt remains committed to developing medications that address the needs of patients, and will work with the FDA throughout the review of the XARTEMIS XR application.”

XARTEMIS XR, an investigational, extended-release oral formulation of oxycodone and acetaminophen uses a dual layer delivery mechanism with both immediate- and extended-release components. In July, the FDA accepted for filing the NDA for XARTEMIS XR and granted priority review. There are currently no extended-release oxycodone/acetaminophen combinations on the market for the management of acute pain.

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 a 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.

Contact:

Mallinckrodt

Lynn Phillips, 314-654-3263

Manager, Media Relations

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

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