News Release
Mallinckrodt New Drug Application Granted Priority Review by FDA
Mallinckrodt’s MNK-795 – controlled-release oxycodone/acetaminophen
combination accepted for filing by U.S. Food and Drug Administration
HAZELWOOD, Mo.--(BUSINESS WIRE)--Jul. 29, 2013--
Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing the New Drug Application
(NDA) for MNK-795 and granted priority review. MNK-795 is a
controlled-release oral formulation of oxycodone and acetaminophen that
has been studied for the management of moderate to severe acute pain
where the use of an opioid analgesic is appropriate. FDA priority review
is a defined NDA review process used for drugs that, if approved, offer
significant improvements in the safety or effectiveness of the treatment
when compared to standard applications.
If approved, MNK-795 would be a controlled-release oxycodone and
acetaminophen combination medication that has immediate and extended
release components. The dosage form was designed using Depomed’s
advanced Acuform® drug delivery technology with tamper-resistant
properties.
“Despite the number of available pain medications, patients continue to
experience unresolved pain and lack treatment options that offer
fast-acting and long-lasting relief. We are pleased the FDA granted
priority review designation,” said Mark Trudeau, President and Chief
Executive Officer, Mallinckrodt Pharmaceuticals. “Mallinckrodt has
unique capabilities in complex formulations such as MNK-795 and this
marks an important milestone for us as our first NDA acceptance as an
independent specialty pharmaceutical company.”
Mallinckrodt’s submission is based on data from a comprehensive clinical
trial program for MNK-795 that included 14 clinical studies with 1,281
patients. The studies evaluated pharmacokinetics, efficacy, safety and
abuse liability.
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 direct sales in roughly 50 countries and distribution in
approximately 40 countries. The company’s 2012 revenue totaled $2.1
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 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.
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