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Mallinckrodt Pharmaceuticals (MNK)'s Extended-Release Pain Drug Meets Main Goal in Phase 3 Trial


9/5/2013 11:19:45 AM

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Mallinckrodt Pharmaceuticals Announces Positive Phase 3 Efficacy Results for MNK-795, an Extended-Release Oxycodone/Acetaminophen Combination

LAS VEGAS--(BUSINESS WIRE)--Mallinckrodt (NYSE: MNK) today reported data that investigational drug MNK-795 achieved the primary endpoint in a Phase 3 efficacy trial in the treatment of acute pain following a bunionectomy. In the study, MNK-795 showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours. The data is being presented at PAINWeek, a national conference on pain for frontline practitioners, which is being held in Las Vegas September 4-7, 2013.

MNK-795 is an investigational, extended-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. The tablet was designed using technology with immediate and extended-release components and potentially tamper-resistant properties. In July, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for MNK-795 and granted priority review.

“Mallinckrodt is dedicated to developing and providing safe and effective medications for the treatment of patients with pain, and we believe these data represent an important milestone toward this commitment,” said Tom Smith, MD, Chief Medical Officer at Mallinckrodt. “We are pleased that MNK-795 met the primary endpoint of the study and we are excited to be able to share the clinical story for this product by presenting these and other data at PAINWeek.”

The Phase 3 study was part of a 505 (b)(2) application, which is a regulatory pathway relying, in part, on data from existing reference drugs. Mallinckrodt examined patients in the bunionectomy setting, as it is a standard outpatient surgery in the acute pain space and a relevant efficacy study for this regulatory pathway.

Mallinckrodt also conducted – and will present at PAINWeek – data from several trials, including the pharmacokinetics, abuse liability, bioavailability, dose proportionality, and tolerability of MNK-795.

Study Details

The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose clinical trial comparing MNK-795 with placebo in 329 patients with acute pain following a unilateral first metatarsal bunionectomy. Subjects received either a fixed-dose of study medication (MNK-795, 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen tablets) of 2 tablets every 12 hours over 48 hours, or placebo. Supplemental ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-795 and placebo arms. Pain intensity was recorded at 2, 4, 8, and 12 hours after each dose, with additional recordings at 15, 30, 45, 60, and 90 minutes after the first dose.

The study evaluated the efficacy and safety of MNK-795 in patients with moderate to severe acute pain. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48). The most common adverse events associated with the use of MNK-795 were nausea, dizziness, headache, vomiting, constipation, and somnolence (sleepiness).

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 other countries. The Company’s 2012 revenue totaled $2.1 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.

Contacts

Mallinckrodt

Lynn Phillips, 314-654-3263

Manager, Media Relations

lynn.phillips@mallinckrodt.com

or

Meredith Fischer, 314-654-6595

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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