October 01, 2014 11:57 PM ET

Biotechnology

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

Phone:

650-266-0000

Fax:

650-266-0100

Key Executives for Onyx Pharmaceuticals, Inc.

Chairman
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 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.

Amgen Inc. and its Subsidiary Onyx Pharmaceuticals, Inc. Data at ASCO 2014 Highlight Oncology Pipeline and Portfolio

Amgen Inc. and its subsidiary Onyx Pharmaceuticals, Inc. announced data from several studies of both pipeline and marketed products will be presented at the 50(th) Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 30-June 3 in Chicago. The research that will be presented demonstrates Amgen's and Onyx's continued progress in developing treatments for patients with difficult-to-treat cancers, as well as investigating new uses and areas of interest for their current cancer care treatments. During the meeting, Amgen and Onyx will present results from more than 45 studies in 17 different cancers, including six oral presentations and 25 posters across 11 oncology molecules. Blinatumomab (AMG 103) is a bispecific T cell engager (BiTE(R)) antibody and is currently being investigated for the treatment of ALL and non-Hodgkin's lymphoma. BiTE antibodies are designed to engage two different targets simultaneously. This dual binding ability allows BiTE antibodies to act as bridges between T cells (a type of white blood cell capable of killing other cells perceived as threats) and tumor cells. BiTE antibodies place the T cells within reach to inject toxins into the tumor cell. Blinatumomab is designed to direct the T cells to target cells expressing CD19, a protein found on the surface of most B cell-derived leukemias and lymphomas. Blinatumomab has received orphan drug designation from the FDA. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body. Vectibix is the first fully human anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first and only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.

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