December 22, 2014 1:24 AM ET


Company Overview of Onyx Pharmaceuticals, Inc.

Company Overview

Onyx Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapies that target the molecular mechanisms that cause cancer in the United States and internationally. The company, through its collaboration agreement with Bayer HealthCare Pharmaceuticals Inc., develops and markets Nexavar tablet, a multiple kinase inhibitor for the treatment of liver cancer and advanced kidney cancer; and Stivarga tablets to treat metastatic colorectal cancer. It is also conducting Phase III clinical trial on Nexavar for the treatment of liver, kidney, thyroid, breast, and non-small cell lung cancers; and completed Phase III clinical trials on Stivarga to treat...

249 East Grand Avenue

South San Francisco, CA 94080

United States

Founded in 1992

741 Employees





Key Executives for Onyx Pharmaceuticals, Inc.

Age: 54
Executive Vice President
Age: 56
Chief Commercial officer and Executive Vice President
Age: 51
Executive Vice President of Global Research & Development and Technical Operations
Age: 51
Senior Director of Investor Relations
Compensation as of Fiscal Year 2014.

Onyx Pharmaceuticals, Inc. Key Developments

Amgen and Onyx Pharmaceuticals, Inc. Announce Results of the Phase 3 ASPIRE

Amgen and Onyx Pharmaceuticals, Inc. announced results of the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial, which evaluated Kyprolis(R) (carfilzomib) for Injection plus Revlimid(R) (lenalidomide) and dexamethasone (KRd) compared with Revlimid and dexamethasone (Rd) in patients with relapsed multiple myeloma. As previously reported, the ASPIRE study met its primary endpoint by demonstrating that KRd significantly extended the time patients lived without their disease worsening, or progression-free survival (PFS), by 26.3 months compared to 17.6 months with Rd (HR=0.69; 95 % CI: 0.57-0.83; p<0.0001), an 8.7 month improvement in PFS. Secondary endpoints, which are being presented for the first time, included overall survival (OS), overall response rate (ORR), duration of response (DOR), health-related quality of life (HR-QoL) measures and safety. While the data for median OS are not yet mature based on the prespecified statistical boundary at the interim (p=0.005), the analysis showed a trend in favor of KRd compared with Rd (HR=0.79; 95% CI: 0.63-0.99; one-sided p=0.018, two-sided p=0.04). Patients will continue to be monitored for OS. The ORR was 87.1% with KRd and 66.7% with Rd (one-sided p<0.0001, two-sided p<0.001). In the KRd and Rd groups, 14% versus 4.3% of patients achieved a stringent complete response, a measurement indicating superior depth of response. Median DOR was 28.6 months (KRd) and 21.2 months (Rd). KRd consistently improved Global HR-QoL compared with Rd over 18 cycles of treatment (one-sided p=0.0001, two-sided p<0.001). Treatment discontinuation due to an adverse event (AE) occurred in 15.3% (KRd) versus 17.7% (Rd) of patients. In the KRd arm, 7.7% versus 8.5% (Rd) of patients died while still on study treatment or within 30 days of receiving the last dose of study treatment. The most common hematologic treatment-emergent AEs (>=grade 3) included neutropenia (29.6% [KRd] versus 26.5% [Rd]), anemia (17.9% [KRd] versus 17.2% [Rd]) and thrombocytopenia (16.6% [KRd] versus 12.3% [Rd]). The most common nonhematologic treatment-emergent AEs (>=grade 3) included hypokalemia (9.4% [KRd] versus 4.9% [Rd]), fatigue (7.7% [KRd] versus 6.4 % [Rd]) and diarrhea (3.8 % [KRd] versus 4.1 % [Rd]). Other treatment-emergent AEs of interest (all grade) included dyspnea (19.4% [KRd] versus 14.9% [Rd]), hypertension (14.3% [KRd] versus 6.9% [Rd]), acute renal failure (grouped term: 8.4% [KRd] versus 7.2% [Rd]), cardiac failure (grouped term: 6.4% [KRd] versus 4.1% [Rd]) and ischemic heart disease (5.9% [KRd] versus 4.6% [Rd]). Lastly, rates of peripheral neuropathy (grouped term) were 17.1% (KRd) and 17.0% (Rd), respectively.

Amgen Announces Phase 3 ASPIRE Trial of Kyprolis(R) in Patients with Relapsed Multiple Myeloma Met Primary Endpoint

Amgen and its subsidiary, Onyx Pharmaceuticals, Inc. announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis(R) (carfilzomib) for Injection in combination with Revlimid(R) (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95% CI, 0.570, 0.834, p<0.0001). While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favor of KRd that did not reach statistical significance. The safety profile observed in this study is consistent with the current U.S. Kyprolis label, including the rate of cardiac events. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. No new safety signals were identified.

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc. Report Phase 3 Trial Results of NEXAVAR(R) (sorafenib) in Patients with Advanced Breast Cancer

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc. announced that an investigational Phase 3 trial of NEXAVAR(R) (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). Phase 3 Trial Design: The RESILIENCE (Phase 3 TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2--Negative Breast CancEr) trial was a randomized, double-blind, placebo-controlled Phase III study which enrolled 537 patients in more than 20 countries, including the United States, Europe, Japan and Australia. The study evaluated sorafenib in combination with capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer who are resistant to or failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline is not indicated. The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, time to progression, overall response rate, disease control rate, duration of response, patient reported quality of life and safety. Patients were randomized to receive either 600 mg of oral sorafenib or matching placebo daily on a continuous schedule, in addition to 1,000 mg/m(2) of capecitabine twice daily for 14 days of a 21 day cycle. NEXAVAR(R) (sorafenib) Tablets: NEXAVAR is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. NEXAVAR is thought to inhibit both the tumor cell and tumor vasculature. in vitro studies, NEXAVAR has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

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