Onyx Pharmaceuticals and Bayer HealthCare have restructured their partnership for the global development and marketing of Nexavar® and entered into a new agreement related to Bayer’s regorafenib, a late-stage oncology compound.
Under terms of the agreements Bayer will have final decision-making authority for global development and commercialization. Onyx will receive a royalty on future global net sales in oncology. Bayer will contract the Onyx sales force to promote regorafenib in the U.S.
Regarding Nexavar, Bayer will purchase Onyx’ royalty rights for sales of the product in Japan in exchange for a one-time payment to Onyx. Bayer will have no obligation to pay Nexavar royalties to Onyx on Japanese sales after December 31.
Onyx and Bayer are free to use their respective Nexavar sales forces to promote regorafenib and additional products outside of the collaboration in the future. Further, in the event of a change of control or acquisition of Onyx, the current profit-sharing, co-development, and U.S. co-promotion of Nexavar will be preserved. These agreements also settle and dismiss all claims related to the complaint filed by Onyx against Bayer.
"These new agreements strengthen the collaboration and provide Onyx the opportunity to participate significantly in the market potential of regorafenib," remarks N. Anthony Coles, M.D., president and CEO of Onyx. "Together we are taking our collaboration to the next level by more effectively structuring our future working relationship."
Regorafenib is an oral multikinase inhibitor of angiogenic, stromal, and oncogenic receptor tyrosine kinases (TK). It is in Phase III trials for colorectal cancer and gastrointestinal stromal tumors.
Nexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. It is reportedly sanctioned in more than 100 countries.
Global Nexavar net sales were $245.7 million for the second quarter of this year, an increase of $9.6 million, or 4%, from the same period in 2010. For the current second quarter, Onyx reported total revenue from the Nexavar collaboration of $68 million compared to $68.8 million for the same period in 2010. Nexavar net sales for the first six months of 2011 were $481.1 million compared to $450.5 for the first half of 2010.