Covidien, a global provider of healthcare products, andNuvo Research Inc., a Canadian drug development company, todayannounced that the U.S. Food and Drug Administration (
FDA) has approved theNew Drug Application for Pennsaid Topical Solution (diclofenac sodiumtopical 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 ofthe knee.
Nuvo develops drug products delivered to and through the skin using itstopical and transdermal drug delivery technologies. Covidien is the largestsupplier of controlled pain medications in the United States based on numberof prescriptions.
"FDA approval of Pennsaid is the most significant milestone in Nuvo'shistory," said Dan Chicoine, Chairman of Nuvo Research. "We are thrilled thatwe have been able to successfully navigate a very challenging regulatorypathway for this product and look forward to the upcoming launch of Pennsaidin the U.S. by Covidien. This will support the development of our productpipeline as we progress toward becoming the global leader in the research anddevelopment of drug products delivered to or through the skin."
"Building on more than a century of pain treatment experience, Covidien isfocused on expanding the limits of pain therapy by combining proven drugs withinnovative delivery systems," said Timothy R. Wright, President,Pharmaceuticals, Covidien. "We are pleased to be collaborating with NuvoResearch on this opportunity to expand our branded pharmaceutical portfolio byselling and marketing Pennsaid throughout the United States."
In June, the companies announced that Mallinckrodt Inc., a Covidiencompany, had entered into a license and development agreement with Nuvo thatencompasses Pennsaid Topical Solution and its follow-on topical diclofenacformulation, Pennsaid(R) Plus Gel, which is currently under development. Underthe agreement, Covidien is responsible for all U.S. commercializationactivities, including marketing, selling and medical education and isresponsible for the clinical development of Pennsaid Plus. Nuvo owns andmaintains the intellectual property rights to the products and also will beresponsible for manufacturing.
As a result of the FDA approval of Pennsaid Topical Solution, Nuvo willreceive a US$15 million milestone payment from Covidien. Going forward, Nuvowill receive royalties on net U.S. sales of Pennsaid at rates that areconsistent with industry standards. Nuvo will also be eligible to receiveadditional escalating sales milestone payments for Pennsaid and Pennsaid Plustotaling up to US$100 million.
The launch of Pennsaid Topical Solution, which Covidien anticipates in thefirst half of calendar 2010, will include a NSAID medication guide forprescribers, pharmacists and patients.