Date: 2011-10-12
Type of information: Development agreement
Compound: Nexavar® (sorafenib) and regorafenib
Company: Bayer HealthCare (Germany) Onyx Pharmaceuticals (USA)
Therapeutic area: Cancer - Oncology
Type agreement: development
commercialisation
Action mechanism: multi-kinase inhibitor. Stivarga® (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.
Disease: liver cancer, advanced kidney cancer, hepatocellular carcinoma, advanced renal cell carcinoma
Details: Bayer HealthCare and Onyx Pharmaceuticals have restructured their partnership for the global development and marketing of Nexavar® (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound.
Under the terms of the agreements, regorafenib is a Bayer compound, and Bayer will have the final decision-making authority for global development and commercialization. Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the United States.
The status of Nexavar® under the revised Collaboration Agreement remains largely unchanged. Bayer and Onyx are free to use their respective Nexavar® sales forces to promote regorafenib and additional products outside of the collaboration in the future. Bayer will purchase Onyx’s 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 royalties to Onyx after December 31, 2011. 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 Corporation and Bayer A.G. in the U.S. District Court (Case No. CV09-2145 MHP).
Financial terms:
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