ST. LOUIS--(BUSINESS WIRE)--Nov. 25, 2013--
(NYSE: MNK) today announced that the U.S. Food and Drug Administration
(FDA) extended the review of the New Drug Application (NDA) for
investigational compound XARTEMIS™ XR (oxycodone
hydrochloride and acetaminophen) Extended-Release Tablets (CII).
XARTEMIS XR, previously known as MNK-795, was studied for the management
of moderate to severe acute pain where the use of an opioid analgesic is
The three-month extension from the FDA is in response to additional data
submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will
continue discussions regarding labeling as part of the application
review throughout this period.
“If approved, we believe that XARTEMIS XR could provide an important new
option as an extended-release treatment for patients with acute pain,”
said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt.
“As a leader in pain management, Mallinckrodt remains committed to
developing medications that address the needs of patients, and will work
with the FDA throughout the review of the XARTEMIS XR application.”
XARTEMIS XR, an investigational, extended-release oral formulation of
oxycodone and acetaminophen uses a dual layer delivery mechanism with
both immediate- and extended-release components. In July, the FDA
accepted for filing the NDA for XARTEMIS XR and granted priority review.
There are currently no extended-release oxycodone/acetaminophen
combinations on the market for the management of acute pain.
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 a commercial presence in
roughly 70 countries. The company’s 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 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.
Lynn Phillips, 314-654-3263
Senior Vice President, Communications
Vice President, Investor Relations