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June 03, 2015 8:38 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.

Chief Financial Officer
Head of Global Medical & Scientific Affairs and Vice President
Head of Law and Associate General Counsel
Head of Corporate Affairs
Chief Commercial Officer and Senior Vice President
Compensation as of Fiscal Year 2014.

Onyx Pharmaceuticals, Inc. Key Developments

Amgen to Close Onyx San Francisco Facility

Amgen Inc. will cut about 300 jobs and close a facility of its Onyx subsidiary in South San Francisco amid a restructuring of the biotechnology company's cancer business. In addition, about 250 sales and medical staff of Onyx will shift to Amgen's 1000 Oaks headquarters as well as its own research facility in South San Francisco.

Amgen and Onyx Pharmaceuticals, Inc. Announce The European Medicines Agency Acceptance Of Kyprolis® (Carfilzomib) Marketing Authorization Application for The Treatment Of Relapsed Multiple Myeloma

Amgen and its subsidiary Onyx Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial as well as other relevant data.

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.

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