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FDA Approves Pennsaid® Topical Solution

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Covidien and Nuvo Research Inc. have 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.

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.