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Mallinckrodt Pharmaceuticals Signs Distribution Agreement with Amneal Pharmaceuticals LLC

Three-year distribution agreement for a generic version of Suboxone^®

HAZELWOOD, Mo.--(BUSINESS WIRE)--Aug. 20, 2013-- Mallinckrodt (NYSE: MNK) announced today that it has entered into an agreement with Amneal Pharmaceuticals LLC to distribute to addiction treatment centers its Buprenorphine HCl and Naloxone HCl Dihydrate Sublingual Tablets (CIII), a generic version of Suboxone^®, manufactured in Amneal’s Hauppauge, New York, facility. The product is a prescription medication indicated for the maintenance treatment of opioid dependence. The contract covers a period of three years, with an option to extend.

Mallinckrodt is a major supplier of generic opioid dependence products to U.S. addiction treatment centers. The Company is leveraging its long-established supply chain expertise to extend the number of products it distributes to these centers.

“The core competencies we have built during the course of our 145-year history, particularly our extensive distribution network and expertise in handling controlled substances, make us an ideal partner for Amneal,” said Walt Kaczmarek, Vice President and General Manager, Specialty Generics, Mallinckrodt. “This agreement demonstrates our continued focus to unlock our potential and drive growth based on what we do well, within our generic specialty pharmaceuticals business.”

This collaboration, the first between Mallinckrodt and Amneal, covers both strengths of Buprenorphine HCl and Naloxone HCl Dihydrate Sublingual Tablets (CIII) available on the market, the 8 mg/2 mg dosage strength and the 2 mg/0.5 mg dosage strength.

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 a direct sales presence 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.

ABOUT AMNEAL

Amneal Pharmaceuticals, LLC, is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey, with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S. as well as abroad. For more information, visit www.amneal.com.

Suboxone is a registered trademark of Reckitt Benckiser Healthcare (UK) Limited.

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.

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Source: Mallinckrodt

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
or
Amneal
Cheryl Lechok, 203-961-9280
Amneal Media Relations Representative
clechok@optonline.net