Nuvo Research and Covidien sign U.S. license and development agreement for Pennsaid(R)...

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Tue Jun 16, 2009 7:01am EDT

Nuvo Research and Covidien sign U.S. license and development agreement for
Pennsaid(R) and Pennsaid Plus(R)

MISSISSAUGA, ON, June 16 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX:
NRI) a Canadian drug development company focused on the research and
development of drug products delivered to and through the skin using its
topical and transdermal drug delivery technologies, today announced that it
has entered into a license and development agreement with Mallinckrodt Inc., a
subsidiary of Covidien (NYSE:COV), a leading global provider of healthcare
products, granting it exclusive rights to market and sell Pennsaid(R), and its
follow-on product, Pennsaid Plus(R), in the United States.
Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory
drug ("NSAID") candidates. Nuvo has been advised by the U.S. Food and Drug
Administration ("FDA") that it expects to respond to Nuvo's resubmitted new
drug application for Pennsaid by August 5, 2009.
Under the terms of the license and development agreement, Nuvo will receive an
up-front, non-refundable payment of US$10 million. In addition, Nuvo is
eligible to receive a US$15 million milestone payment on Pennsaid's approval
by the FDA, which will increase to US$20 million if certain labeling criteria
are agreed to by the FDA. Nuvo will receive royalties on net U.S. sales of
Pennsaid and Pennsaid Plus at rates that are consistent with industry
standards for products at similar stages of development. Nuvo will be eligible
to receive additional escalating sales milestone payments for the products
totaling up to US$100 million.
Covidien will assume responsibility for all future development activities and
expenses for Pennsaid Plus, including two Phase 3 clinical trials that
Covidien expects to commence in 2010. Covidien has a right to negotiate with
Nuvo on an exclusive basis for a period of 90 days to expand the licensed
territory to include additional unlicensed countries worldwide. Nuvo will
manufacture and supply Pennsaid and Pennsaid Plus to Covidien from its
existing manufacturing facility in Varennes, Quebec.
Covidien is a leading global healthcare products company with revenues of
nearly US$10 billion in 2008, and more than 41,000 employees in 59 countries
worldwide. Its products are sold in more than 140 countries. A market study
commissioned by Nuvo estimates that the market for topical NSAIDs will grow to
US$2 billion annually within five years.
"Covidien is an ideal partner with the infrastructure, market reach, resources
and commitment to maximize the commercial potential of Pennsaid and Pennsaid
Plus," said Dan Chicoine, Chairman of Nuvo. "It is aggressively adding
resources to maximize the value of the Pennsaid/Pennsaid Plus franchise and
pursue its strategy of becoming a global presence in the treatment of pain."

About Pennsaid and Pennsaid Plus

Pennsaid, Nuvo's lead product, combines a transdermal carrier (containing
dimethyl sulfoxide, popularly known as "DMSO") with diclofenac sodium, a
leading non-steroidal anti-inflammatory drug ("NSAID"), and delivers the
active drug through the skin directly to the site of pain. Pennsaid Plus is
the follow-on product candidate to Pennsaid. Pennsaid Plus will feature a
twice-daily dosing regime as a gel formulation.

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, Quebec and
Wanzleben, Germany and a research and development Center in San Diego,
California. For more information, please visit www.nuvoresearch.com

This document contains forward-looking statements. Some forward-looking
statements may be identified by words like "expects", "anticipates", "plans",
"intends", "indicates" or similar expressions. These forward-looking
statements, by their nature, necessarily involve risks and uncertainties that
could cause actual results to differ materially from those contemplated by the
forward-looking statements. Nuvo considers the assumptions on which these
forward-looking statements are based to be reasonable at the time they were
prepared, but caution that these assumptions regarding future events, many of
which are beyond the control of the Company, may ultimately prove to be
incorrect. Factors and risks, which could cause actual results to differ
materially from current expectations, are discussed in the annual report, as
well as in Nuvo's Annual Information Form for the year ended December 31,
2008. Nuvo disclaims any intention or obligation to update or revise any
forward-looking statements whether a result of new information or future
events, except as required by law. For additional information on risks and
uncertainties relating to these forward-looking statements, investors should
consult the Company's ongoing quarterly filings, annual report and Annual
Information Form and other filings found on SEDAR at www.sedar.com

SOURCE  Nuvo Research Inc.

about Nuvo, please contact: Media and Investor Relations, Adam Peeler, The
Equicom Group Inc., Tel: (416) 815-0700 x225, email: apeeler@equicomgroup.com
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