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Mallinckrodt Pharmaceuticals to Unveil First Clinical Data on MNK-795, an Extended-Release Oxycodone and Acetaminophen Combination, at PAINWeek

Data describe a human abuse liability study, delivery profile and efficacy of MNK-795

ST. LOUIS--(BUSINESS WIRE)--Aug. 28, 2013-- Mallinckrodt (NYSE: MNK) announced today that the first clinical data on MNK-795 will be presented at PAINWeek 2013, to be held September 4-7 in Las Vegas. MNK-795 is an extended-release oral formulation of oxycodone and acetaminophen that has been studied in clinical trials for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. On July 29, Mallinckrodt announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for MNK-795 and granted priority review.

The data to be presented include results from a human abuse liability (HAL) study comparing certain abuse-related characteristics of intact and tampered-with MNK-795 with that of intact and tampered-with Percocet^®1 (an immediate-release oxycodone/acetaminophen formulation); single- and multi-dose pharmacokinetic studies that characterize the drug release profile with immediate- and extended- release components over the 12-hour dosing interval; and a study of the compound’s efficacy and safety in an acute pain model.

“We are pleased to share the first results from our MNK-795 clinical development program which, if approved, could be a critical milestone for us as an independent specialty pharmaceuticals company,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “Mallinckrodt’s investment in MNK-795 exemplifies our longstanding commitment to provide medications for the treatment of patients with acute pain.”

Currently, there are no extended-release oxycodone/acetaminophen combinations on the market for acute pain. In clinical trials, MNK-795 has been studied as two tablets dosed every 12 hours. The dosage form was designed using technology with both immediate- and extended-release components and potentially tamper-resistant properties.

In all, 15 abstracts for MNK-795 will be presented, including the following:

Human Abuse Liability/tamper resistance abstracts

• Comparison of Subjective Drug Effects of Orally Administered MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) Versus Immediate-Release Oxycodone/Acetaminophen Tablets in Recreational Users of Prescription Opioids
• Evaluation of the Tamper-Resistant Properties of MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
• Relationship Between Oxycodone Pharmacokinetics and Subjective Drug Effects Following Oral Administration of an Immediate-Release Combination of Oxycodone and Acetaminophen and MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets

Pharmacokinetic abstracts

• Comparison of the Pharmacokinetic Profile of a Single Dose of MNK-795, a Controlled-Release Oxycodone and Acetaminophen Combination Tablet (CR OC/APAP) and Marketed Immediate-Release Opioids and Opioid/Acetaminophen Combination Tablets
• Comparison of the Pharmacokinetic Profile of MNK-795, a New Oral, Controlled-Release Formulation of Oxycodone/Acetaminophen (CR OC/APAP) Analgesic at Steady State Versus Marketed Immediate-Release Tablets
• Single Dose Pharmacokinetics of 1 and 2 Tablets of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) Compared with Immediate-Release Oxycodone and Acetaminophen
• Steady-State Pharmacokinetics of 1 and 2 Tablets of MNK-795, a Controlled-Release Oxycodone and Acetaminophen (CR OC/APAP) Combination, Compared with Immediate-Release Oxycodone and Acetaminophen
• Single-Dose Pharmacokinetics, Bioavailability, and Safety of MNK-795, a Controlled-Release Oxycodone and Acetaminophen Combination Analgesic (CR OC/APAP), Under Fed and Fasted Conditions
• Half-Value Duration Analysis for Acetaminophen After Single and Multiple Doses of Oral MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
• Half-Value Duration Analysis for Oxycodone After Single and Multiple Doses of Oral MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
• Dose Proportionality and Linearity of Oxycodone After Single or Multiple Oral Doses of MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
• Dose Proportionality and Linearity of Acetaminophen After Single or Multiple Oral Doses of MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets

Efficacy and safety abstracts

• A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model
• Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model
• Open-Label Safety of MNK-795, Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in Patients with Osteoarthritis or Chronic Low Back Pain

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 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.

¹ Percocet is a registered trademark of Endo Pharmaceuticals Inc.

Source: Mallinckrodt

Mallinckrodt
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