FDA approves Pennsaid® Topical Solution
November 5, 2009
Covidien, Nuvo Research Inc. Collaboration Achieves Significant Milestone in Support of Covidien's Expansion in Branded Pain Management Market
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
"FDA approval of Pennsaid is the most significant milestone in Nuvo's history," said
"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
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.
Nuvo Research will host a conference call and webcast
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
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,
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
For further information: Nuvo Research Inc., Adam Peeler, The Equicom Group Inc., Tel: (416) 815-0700 x225, email: [email protected]; Covidien, JoAnna Schooler, Director, Communications, Pharmaceuticals, (314) 654-3543, [email protected]; Coleman Lannum, CFA, Vice President, Investor Relations, (508) 452-4343, [email protected]; Bruce Farmer, Vice President, Public Relations, (508) 452-4372, [email protected]; Brian Nameth, Director, Investor Relations, (508) 452-4363, [email protected]