Mallinckrodt plc (NYSE: MNK) said today that the U.S. District Court for the District of Maryland, Greenbelt Division, has denied its motion for a temporary restraining order (TRO) against U.S. Food and Drug Administration’s (FDA) November 13, 2014 reclassification of its generic methylphenidate hydrochloride extended release (ER) medicines.
“Mallinckrodt is disappointed by the court’s decision today, and we remain fully confident that our methylphenidate ER drugs are safe and effective when used in accordance with the approved labels,” said Peter Edwards, Mallinckrodt Senior Vice President and General Counsel. “We are evaluating all available options and look forward to engaging in meaningful dialogue with the FDA regarding this matter.”
Mallinckrodt has conducted a thorough examination of its pharmacovigilance database reports and found that in the 21 months since product launch, out of the more than 88 million doses of Mallinckrodt’s methylphenidate ER medicines that have been prescribed the company has received only 68 investigated and confirmed adverse event reports related to a lack of efficacy when the patient switched from the reference listed drug Concerta® to the company’s methylphenidate ER medicines.
Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology along with analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment include contrast media and nuclear imaging agents. Mallinckrodt has more than 5,500 employees worldwide and a commercial presence in roughly 65 countries. The company's fiscal 2014 revenue totaled $2.54 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CONCERTA® is a registered trademark of ALZA Corporation
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Statements in this press release that are not strictly historical, including statements regarding, future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting our business and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which we operate; changes in laws and regulations; our ability to identify, acquire or close acquisitions; our ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; our ability to successfully develop or commercialize new products; our ability to protect intellectual property rights; our ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; our reliance on certain individual products that are material to our financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; limited clinical trial data for H.P. Acthar® Gel; complex reporting and payment obligations under healthcare rebate programs; our ability to achieve anticipated benefits of price increases; our ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; and the effectiveness of information technology infrastructure. 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 26, 2014. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Vice President, Investor Relations