Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to extending and enhancing the lives of patients with cancer and other serious illnesses. We are focused on developing innovative targeted therapies to transform the treatment of life-threatening diseases.

Our lead product, Nexavar® (sorafenib) tablets, is the only systemic therapy approved for liver cancer and has been established as an important treatment for advanced kidney cancer. Approved in more than 100 countries, Nexavar has benefited more than 200,000 patients to date and is currently being evaluated in a range of other cancers. Nexavar, a novel, oral drug that targets key proteins involved in the growth and spread of cancer, is being developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals, Inc.  Beyond Nexavar, we are advancing carfilzomib, a selective next-generation proteasome inhibitor, in late-stage clinical development. In a broad range of clinical studies, carfilzomib has demonstrated encouraging activity together with durable disease control and long-term tolerability across a range of treatment settings and patient populations.  These results suggest carfilzomib’s potential as a cornerstone of care for patients at every stage of their disease.  Based on positive complete results from a Phase 2b study of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma, we are planning to submit a new drug application (NDA) as early as mid-2011 for accelerated U.S. approval.  In addition, we are conducting a randomized Phase 3 study, known as the ASPIRE trial, in patients with relapsed multiple myeloma comparing carfilzomib in combination with lenalidomide and low-dose dexamethasone versus lenalidomide plus dexamethasone alone.  This study is being performed to register carfilzomib worldwide in the setting of relapsed multiple myeloma.  To support registration in Europe, we are currently conducting a Phase 3 study, known as the FOCUS trial, of single-agent carfilzomib in the same population of late-stage patients.  We are also developing two other novel proteasome inhibitors, including an oral protease inhibitor (ONX 0912) and an immunoproteasome inhibitor (ONX 0914).  The proteasome has been validated as an important clinical target in cancer, and our goal is to develop next-generation agents whose high degree of specificity provides potential increased therapeutic efficacy and reduced off-target toxicities.  Another compound in our development pipeline is ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase (TS).  In addition, we have the potential to receive milestone and royalty payments from PD 0332991, an oral, small molecule cyclin-dependent kinase 4/6 (CDK4/6) inhibitor being developed by Pfizer, formerly Warner-Lambert Company and an early collaborator of Onyx.  Onyx today has three major platforms for growth:  our core asset Nexavar, our emerging proteasome inhibitor franchise, and our early stage pipeline.  Accordingly, we have established a set of priorities directing our expansion and diversification:

  • Maintain a strong financial profile
  • Build a proteasome inhibitor franchise
  • Sustain and increase Nexavar growth
  • Leverage pipeline assets

We believe Onyx is uniquely positioned within the biopharmaceutical industry, combining the commercial experience and strong business fundamentals of an established company with the innovation, flexibility, transparency, and collaborative approach of an entrepreneurial start-up. Onyx common stock is traded on the Nasdaq Global Market under the symbol ONXX.

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