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Bayer, Onyx Pharmaceuticals restructure Nexavar partnership
SAN FRANCISCO— Onyx Pharmaceuticals, Inc. and Bayer HealthCare announced today the restructuring of their long-term partnership for the global development and marketing of Nexavar (sorafenib) tablets, and also entered into a new agreement related to Bayer's late-stage oncology compound, regorafenib.
Per the terms of the agreement, Bayer will have final decision-making authority for regorafenib in terms of global development and commercialization since Bayer retains ownership of the compound. Bayer will also contract the Onyx sales force to promote regorafenib, in addition to Bayer's own sales force, in the United States. For its part, Onyx stands to receive a royalty on any future global net sales of regorafenib in oncology.
"These new agreements strengthen the collaboration and provide Onyx the opportunity to participate significantly in the market potential of regorafenib," N. Anthony Coles, M.D., President and Chief Executive Officer of Onyx, said in a press release. "Together we are taking our collaboration to the next level by more effectively structuring our future working relationship. Onyx and Bayer are committed to benefiting patients worldwide and ensuring that the potential of both Nexavar and regorafenib is fully realized."
Nexavar's status under the two companies' revised collaboration agreement will remain unchanged for the most part. Both Bayer and Onyx are free to utilize their respective Nexavar sales forces for the promotion of regorafenib as well as additional products outside of the collaboration in the future. Bayer will be purchasing Onyx's royalty tights for sales of the product in Japan, in exchange for which Onyx will receive a one-time payment. Pending that purchase, Bayer will not have any obligation to pay royalties to Onyx on Japanese sales of Nexavar after Dec. 31 of this year.
In addition, should a change of control or acquisition of Onyx occur, the currently established profit-sharing, co-development and U.S. co-promotion of Nexavar will remain the same. the agreements also settle and dismiss the claims related to the complaint Onyx filed against Bayer Corporation and Bayer A.G. in the U.S. District Court.
"These agreements set the stage for the next chapter in our successful partnership," Dr. Joerg Reinhardt, Chairman of the Bayer HealthCare Executive Committee, noted in a press release. "Innovation is central to Bayer's mission 'Science for a Better Life,' and our ongoing collaboration with Onyx demonstrates the priority we place on working with partners to identify, develop and commercialize new medicines to meet unmet or under-served medical needs."
Regorafenib is an oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases, and is currently undergoing clinical triasl to determine its potential as a treatment for various types of tumors. Nexavar has been shown to inhibit the tumor cell as well as tumor vasculature, and has been approved in the United States for the treatment of unresectable liver cancer as well as advanced kidney cancer.
Bayer and Onyx have been working together on Nexavar for several years in a variety of indications. It is approved for kidney and liver cancer patients, but has also been tested as a treatment for thyroid cancer, non-small cell lung cancer and breast cancer. In preclinical studies, it has proven to inhibit members of two classes of kinases that are believed to be involved in cell proliferation as well as angiogenesis. The kinases included consist of Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
SOURCE: Onyx Pharmaceuticals press release