FDA Approves Pennsaid® Topical Solution

* Reuters is not responsible for the content in this press release.

Thu Nov 5, 2009 7:00am EST

Covidien, Nuvo Research Inc. Collaboration Achieves Significant Milestone in
Support of Covidien`s Expansion in Branded Pain Management Market
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, Québec 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



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.