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May 23, 2012

Nexavar Fails to Meet Primary Endpoint in Late-Stage NSCLC Study

  • Partners Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals’ anticancer drug Nexavar® (sorafenib) failed to meet its primary endpoint in a Phase III study in patients with advanced non-small cell lung cancer (NSCLC). The 703-patient MISSION study found that in comparison with placebo and best supportive care, treatment with sorafenib plus best supportive care didn’t improve overall survival, although an improvement in progression-free survival was seen. Enrolled patients all had advanced relapsed or refractory non-squamous NSCLC, and disease that had progressed after two or three previous treatments.

    Sorafenib is a multikinase inhibitor already approved in the U.S. and over 100 other countries for the treatment of unresectable liver cancer and/or advanced kidney cancer. The drug is also being evaluated in a range of additional cancer types, including Phase III studies in breast cancer and thyroid cancer, and Phase III studies as adjuvant therapy for liver cancer and kidney cancer.

    Sorafenib is being developed and marketed globally through a collaboration between Bayer HealthCare Pharmaceuticals and Onyx. Each firm is funding 50% of the development costs worldwide, except for Japan, where Bayer funds all product development. Onyx and Bayer co-promote Nexavar in the U.S. and share equally in any profits or losses. In non-U.S. markets Bayer has exclusive marketing rights and Onyx and Bayer share profits 50/50 globally, excluding Japan, where Bayer paid Onyx a one-time payment of $160 million in 2011 as part of an expanded collaboration agreement.

    Onyx reported revenue of $72 million from Nexavar net sales of in the first quarter 2012, an increase of 7% on the same period in 2011, primarily due to growth in U.S. sales and increased demand in emerging markets, primarily in the Asia Pacific region. The drug was Bayer’s fourth biggest selling pharmaceutical in the first quarter of 2012 and achieved sales of $186 million, up from $172 million during Q1 2011. 


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