U.S. Patent covers the release profile of XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
February 25, 2014 08:30 AM Eastern Standard Time
DUBLIN--(BUSINESS WIRE)--Mallinckrodt (NYSE: MNK) today announced that it was granted a patent from the United States Patent and Trademark Office which contains composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics of XARTEMISTM XR. XARTEMIS XR (formerly known as MNK-795) is an investigational extended-release oral formulation of oxycodone and acetaminophen that has been studied with twice daily dosing for the management of acute pain in a post-surgical model. If approved, XARTEMIS XR will be the first oxycodone and acetaminophen combination medication specifically designed with immediate- and extended-release components. The patent, U.S. Patent Number 8,658,631, was issued on February 25, 2014.
"Mallinckrodt's patent, which includes the product's release profile, underscores our ability to effectively leverage our core formulation capabilities and partnerships."
The release profile of XARTEMIS XR combines Mallinckrodt-proprietary technology and Depomed's advanced Acuform® drug delivery technology. Between the Mallinckrodt and Depomed patent families, Mallinckrodt believes XARTEMIS XR will have strong patent protection for its novel features.
"XARTEMIS XR, a key driver in our near-term pipeline, represents an important component of our strategy to unlock continued potential and grow our branded specialty pharmaceutical portfolio," said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt. "Mallinckrodt's patent, which includes the product's release profile, underscores our ability to effectively leverage our core formulation capabilities and partnerships."
Acuform is a registered trademark of Depomed.
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 specialty generic drugs, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide with sales in roughly 70 countries. The company's fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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 and in subsequent filings. We disclaim any obligation to update these forward-looking statements other than as required by law.
Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-3318
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations