ST. LOUIS and MISSISSAUGA, ON, Aug. 4 /CNW/ - 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 set a new action date under the
Prescription Drug User Fee Act (PDUFA) for Pennsaid (diclofenac sodium)
topical solution 1.5% w/w of November 4, 2009.
During the review process, Nuvo provided the FDA with supplemental
information, which the Agency determined to be a major amendment to the
Pennsaid New Drug Application. As a result, the FDA has extended its action
date by three months to provide time for a full review of the submission.
"We believe we have submitted a high-quality application for Pennsaid and
will continue to work closely with the FDA throughout the remaining review
process," stated Dan Chicoine, Chairman of Nuvo Research.
"Covidien is committed to the future success of Pennsaid topical solution
and we are continuing with our preparations to launch the product anticipating
FDA approval," said Timothy R. Wright, President, Pharmaceutical Products and
Imaging Solutions, Covidien.
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
In June, the companies announced that Covidien's Mallinckrodt Inc.
subsidiary had entered into a license and development agreement with Nuvo that
encompasses Pennsaid Topical Solution and another topical formulation of
diclofenac now under development.
Under the agreement, Nuvo is responsible for regulatory submissions, owns
and maintains the intellectual property, and will be responsible for
manufacturing. Covidien is responsible for all commercialization activities,
including marketing, selling and medical education.
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 four
segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and
Medical Supplies. With 2008 revenue of nearly $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
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. 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. Pennsaid(R) is a trademark of
Nuvo Research, Inc.
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
For further information:
For further information: Contacts - Covidien: Stephen Littlejohn, Vice
President, Communications, Pharmaceutical Products and Imaging Solutions,
(314) 654-6595, firstname.lastname@example.org; Coleman Lannum, CFA, Vice
President, Investor Relations, (508) 452-4343, email@example.com; Bruce
Farmer, Vice President, Public Relations, 508-452-4372,
firstname.lastname@example.org; Brian Nameth, Director, Investor Relations, (508)
452-4363, email@example.com; Contact - Nuvo Research Inc.: Adam
Peeler, The Equicom Group Inc., Tel: (416) 815-0700 x225, email: