Avid Bioservices Inc (CDMO)

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From Bayer HealthCare Homepage: NEXAVAR

We are jointly developing and commercializing our cancer drug Nexavar[color=red][/color]™ (active ingredient: sorafenib) with Onyx Pharmaceuticals, Inc., United States. The successful active ingredient sorafenib, which targets both cancer cells and the vascular system of the tumor, has been registered for the treatment of ­advanced renal cell carcinoma since 2005 and hepatocellular carcinoma since 2007. We plan to develop the product beyond these two therapeutic areas with a broadly based life-cycle management program. Based on the clinical Phase III DECISION study, we submitted sorafenib to the European Medicines ­Agency (EMA) and the FDA in June 2013 for regulatory approval in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine. The FDA granted this approval in ­November 2013 following a priority review. In September 2013, sorafenib was submitted to the Japanese MHLW for marketing authorization for the treatment of thyroid cancer. Sorafenib is also being ­investigated in Phase III registration studies as an adjuvant therapy following curative tumor resection in patients with renal cell carcinoma or hepatocellular carcinoma. We are also conducting Phase III registration studies in breast cancer.
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