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FDA approves Pennsaid(R) Topical Solution

Posted on: Thursday, 5 November 2009, 06:00 CST

ST. LOUIS, MO and MISSISSAUGA, ON, Nov. 5 /PRNewswire-FirstCall/ - 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(R) 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(R) 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.

As a result of the FDA approval of Pennsaid Topical Solution, Nuvo will receive a US$15 million milestone payment from Covidien. Going forward, Nuvo will receive royalties on net U.S. sales of Pennsaid at rates that are consistent with industry standards. Nuvo will also be eligible to receive additional escalating sales milestone payments for Pennsaid and Pennsaid Plus totaling up to US$100 million.

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.

Nuvo Research will host a conference call and webcast November 5, 2009 at 8:30 a.m. ET to discuss this development. To access the conference call by telephone, dial 416-644-3427 or 1-877-974-0454. A live audio webcast will also be available through the Company's website at www.nuvoresearch.com. A replay of the webcast will be available by telephone through November 12, 2009. To access the telephone replay, dial 416-640-1917 or 1-877-289-8525 and enter reservation number 4181693 followed by the number sign.

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

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 atwww.sedar.com

SOURCE Nuvo Research Inc.

Source: PR Newswire

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