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Mallinckrodt Pharmaceuticals Announces Clinical And Commercial Collaboration With Medtronic

Collaboration agreement will focus on furthering pre-clinical, clinical and commercial aspects of intrathecal therapeutics

ST. LOUIS, Mo.--(BUSINESS WIRE)--Jan. 13, 2014-- Mallinckrodt (NYSE: MNK) announced today that it has entered into a multiyear agreement with Medtronic (NYSE: MDT) to advance availability in the U.S. of intrathecal therapeutics for the treatment of chronic pain and severe spasticity.

Under the agreement, the two companies will collaborate on the development and testing of Mallinckrodt’s future intrathecal products for use in Medtronic’s SynchroMed^® Programmable Infusion System. The companies will also develop joint marketing and sales programs to increase awareness and adoption of these drug delivery therapies. Specific terms of the agreement are not being disclosed.

Intrathecal therapeutics use an implanted pump to deliver very small quantities of medications directly to a patient’s spinal fluid. Since this kind of “targeted drug delivery” system combines the use of a medical device with a pharmaceutical agent, the development path can be longer than that for either device or drug alone. This collaboration is intended to accelerate innovation and expand clinician and patient education regarding targeted delivery of drugs for the management of chronic disease.

“This collaboration will allow each organization to leverage their respective strengths – Mallinckrodt in specialty pharmaceuticals and Medtronic in implantable drug delivery technology,” said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt. “Together, we will focus on advancing the development and delivery of therapeutic agents to serve patients suffering from chronic pain or severe spasticity. We are excited about the future of our intrathecal product line, and this agreement will enable us to deliver meaningful solutions to this market.”

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 commercial presence in roughly 70 countries. The company’s fiscal year 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, information technology infrastructure and restructuring activities. These and other factors are identified and described in more detail in the “Risk Factors” section of Mallinckrodt’s Annual Report on Form 10-K for the fiscal year ended September 27, 2013. We disclaim any obligation to update these forward-looking statements other than as required by law.

Source: Mallinckrodt

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
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John Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com