Nuvo Research and Covidien Sign U.S. License and Development Agreement for Pennsaid® and Pennsaid Plus®
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Nuvo Research Inc. has announced that it has entered into a license and development agreement with Mallinckrodt Inc., a subsidiary of Covidien, granting it exclusive rights to market and sell Pennsaid®, and its follow-on product, Pennsaid Plus®, 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 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."
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 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."
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