Published:
FDA Approves Pennsaid Topical Solution
ST. LOUIS & MISSISSAUGA, Ontario - (BUSINESS WIRE) - Covidien (NYSE:COV), a leading global provider of healthcare products,
and Nuvo Research Inc. (TSX:NRI), a Canadian drug development company,
today announced that the U.S. Food and Drug Administration (FDA) has
approved the New Drug Application for Pennsaid Topical
Solution (diclofenac sodium topical solution) 1.5% w/w.
Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug
(NSAID) used for the treatment of the signs and symptoms of
osteoarthritis of the knee.
Nuvo develops drug products delivered to and through the skin using its
topical and transdermal drug delivery technologies. Covidien is the
largest supplier of controlled pain medications in the United States
based on number of prescriptions.
"FDA approval of Pennsaid is the most significant milestone in Nuvo's
history," said Dan Chicoine, Chairman of Nuvo Research. "We are thrilled
that we have been able to successfully navigate a very challenging
regulatory pathway for this product and look forward to the upcoming
launch of Pennsaid in the U.S. by Covidien. This will support the
development of our product pipeline as we progress toward becoming the
global leader in the research and development of drug products delivered
to or through the skin."
"Building on more than a century of pain treatment experience, Covidien
is focused on expanding the limits of pain therapy by combining proven
drugs with innovative delivery systems," said Timothy R. Wright,
President, Pharmaceuticals, Covidien. "We are pleased to be
collaborating with Nuvo Research on this opportunity to expand our
branded pharmaceutical portfolio by selling and marketing Pennsaid
throughout the United States."
In June, the companies announced that Mallinckrodt Inc., a Covidien
company, had entered into a license and development agreement with Nuvo
that encompasses Pennsaid Topical Solution and its follow-on topical
diclofenac formulation, Pennsaid Plus Gel, which is
currently under development. Under the agreement, Covidien is
responsible for all U.S. commercialization activities, including
marketing, selling and medical education and is responsible for the
clinical development of Pennsaid Plus. Nuvo owns and maintains the
intellectual property rights to the products and also will be
responsible for manufacturing.
The launch of Pennsaid Topical Solution, which Covidien anticipates in
the first half of calendar 2010, will include a NSAID medication guide
for prescribers, pharmacists and patients.
About Covidien
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2008 revenue of $10 billion, Covidien has more than
41,000 employees worldwide in 59 countries, and its products are sold in
over 140 countries. Please visit www.covidien.com
to learn more about our business.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products
delivered to and through the skin using its topical and transdermal drug
delivery technologies and on the development of its immune modulation
drug candidate, WF10. Nuvo's lead product is Pennsaid, a topical
non-steroidal anti-inflammatory drug (NSAID). Nuvo intends to leverage
its skin-penetrating technologies to create a portfolio of topical and
transdermal products targeting a variety of indications. Nuvo is a
publicly traded, Canadian pharmaceutical company headquartered in
Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec
and Wanzleben, Germany and a research and development Center in San
Diego, California. For more information, please visit www.nuvoresearch.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. 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 effectively
introduce and market new products or keep pace with advances in
technology, the reimbursement practices of a small number of large
public and private insurers, cost-containment efforts of customers,
purchasing groups, third-party payers and governmental organizations,
intellectual property rights disputes, complex and costly regulation,
including healthcare fraud and abuse regulations, manufacturing or
supply chain problems or disruptions, rising commodity costs, recalls or
safety alerts and negative publicity relating to Covidien or its
products, product liability losses and other litigation liability,
including legacy Tyco-related litigation, divestitures of some of our
businesses or product lines, our ability to execute strategic
acquisitions of, investments in or alliances with other companies and
businesses, competition, risks associated with doing business outside of
the United States, foreign currency exchange rates, issues related to
our existing material weakness in accounting for income taxes or
potential environmental liabilities. These and other factors are
identified and described in more detail in our filings with the SEC. We
disclaim any obligation to update these forward-looking statements other
than as required by law.
Covidien
JoAnna Schooler, 314-654-3543
Director,
Communications
Pharmaceuticals
joanna.schooler@covidien.com
or
Bruce
Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Coleman
Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Brian
Nameth, 508-452-4363
Director
Investor Relations
brian.nameth@covidien.com
or
Nuvo
Research Inc.
The Equicom Group Inc.
Adam Peeler,
416-815-0700 x225
apeeler@equicomgroup.com
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