Onyx is advancing a robust pipeline of innovative compounds targeting several of the most promising molecular pathways in oncology and other serious illnesses, with the goal of extending and enhancing the lives of patients with life-threatening diseases.

The goal of the development program for Nexavar® (sorafenib) tablets, an oral anticancer drug currently approved in two tough-to-treat cancers, is to leverage the drug’s efficacy, tolerability, convenient oral administration, and combinability to address significant unmet needs in the treatment of a range of cancers.  We are also moving carfilzomib, the lead drug candidate in our proteasome inhibitor program, through late-stage clinical trials that will support a new drug application (NDA) filing this summer. Carfilzomib is a selective, next-generation proteasome inhibitor being developed as a treatment for multiple myeloma and solid tumors. In the Nexavar development program, the agent is being evaluated in Phase 3 trials in non-small cell lung cancer, thyroid cancer, breast cancer and as an adjuvant treatment for liver and kidney cancer. In addition, there are several studies evaluating Nexavar in combination with locoregional therapies, such as transarterial chemoembolization (TACE), and in combination with other therapies, such as erlotinib, for the treatment of liver cancer. Nexavar is also being studied as a single agent, as well as in combination with standard chemotherapy drugs and other anticancer agents in multiple Phase 2 trials in breast, colorectal, ovarian and other cancers. Nexavar is being developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals, Inc. In our proteasome inhibitor development program, we are advancing carfilzomib based on encouraging results from a broad clinical trial program in multiple myeloma.  Carfilzomib is currently being evaluated in two Phase 3 clinical trials – a large, international combination study, ASPIRE, and FOCUS, a single-agent study in relapsed and refractory disease to support European registration.  Positive complete results from a  Phase 2b single-agent study, known as the 003-A1 trial, in patients with relapsed and refractory multiple myeloma were reported in December 2010 at the annual meeting of the American Society of Hematology.  Based on these results, we have initiated a rolling submission of the NDA for potential accelerated approval in the U.S. Carfilzomib is also being evaluated in a Phase 1b/2 study in solid tumors.  The proteasome has been validated as an important clinical target in cancer, and Onyx is developing selective, next-generation proteasome inhibitors with the goal of increasing therapeutic efficacy and reducing off-target toxicities. Our proteasome inhibitor program also includes ONX 0912, an oral proteasome inhibitor currently in Phase 1 testing in solid tumors, and ONX 0914, an immunoproteasome inhibitor with preclinical activity in models of autoimmune disorders. Our diverse pipeline also includes several earlier-stage compounds.  We are developing ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase (TS), which is in a Phase 1 clinical trial in solid tumors.  Our portfolio also includes PD 0332991, an oral, small molecule cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, now in Phase 2 clinical development, which resulted from a collaboration with Warner-Lambert Company, now Pfizer, and which could result in Onyx receiving milestone and royalty payments.

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