美国Onyx Pharmaceuticals, Inc.
2009 Onyx将以8.51亿美元收购抗癌药开发商Proteolix

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. Our approved product, Nexavar® (sorafenib) tablets, is a novel, oral multiple kinase inhibitor that targets proteins involved in both tumor cell proliferation and angiogenesis. Nexavar is approved in more than 80 countries for the treatment of patients with unresectable liver cancer and in more than 90 countries for the treatment of patients with advanced kidney cancer.

As part of a broad clinical development program, Nexavar is also being evaluated in multiple Phase 3 and Phase 2 trials as a single agent or combination treatment in a wide range of cancers, including lung cancer, thyroid cancer, breast cancer, colorectal cancer, ovarian cancer, and as an adjuvant therapy for liver cancer and kidney cancer. Nexavar is being developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals.

Beyond Nexavar, Onyx is pursuing a proteasome inhibition development program. The proteasome has been validated as an important clinical target in cancer, and Onyx is developing next-generation proteasome inhibitors with a high degree of selectivity, with the goal of increasing therapeutic efficacy and reducing side effects.

The lead product candidate in this program is carfilzomib, a selective, next-generation compound that is currently in multiple clinical trials to evaluate its safety and efficacy for the treatment of patients with multiple myeloma and solid tumors. Among these studies, enrollment has been completed in a Phase 2b monotherapy trial evaluating carfilzomib in patients with relapsed and refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010 and potential accelerated approval in 2011.

In addition to carfilzomib, the proteasome inhibitor development program includes ONX 0912 (formerly PR-047), an oral proteasome inhibitor that is expected to enter Phase 1 testing in hematologic and solid tumors in 2010, and ONX 0914 (formerly PR-957), an immunoproteasome inhibitor with activity in preclinical models of autoimmune disorders.

Onyx has also established a development pipeline of anticancer compounds at various stages of clinical testing. Onyx is developing ONX 0801, a targeted alpha-folate inhibitor that recently entered into Phase 1 testing. Onyx also has options to license the rights to two Janus Kinase 2 (JAK2) inhibitors: ONX 0803, in Phase 1 studies to treat primary myelofibrosis and lymphoid malignancies, and ONX 0805, currently in preclinical development. PD 332991, an oral, small molecule cyclin-dependent kinase 4 (CDK4) inhibitor, resulted from a collaboration with Warner-Lambert Company, now Pfizer. Pfizer is responsible for all product development activities and costs. In exchange, Onyx will receive milestone payments and a single-digit royalty on any worldwide sales of the product.

Onyx common stock is traded on the Nasdaq Global Market under the symbol ONXX.