SFJ Pharma (#SFJPharma) and Pfizer Inc. (#PfizerInc) announced a joint venture for the Phase 3 testing of Pfizer’s investigational agent axitinib (#axitinib) in Asia. SFJ Pharma is well known for its unique co-development partnering model for some of the world’s top Pharmaceutical and Biotechnology companies.
As per the agreement signed between the two companies, SFJ will be the financial backbone and the clinical development supervision to support Pfizer generate the clinical data that would reviewed by regulatory authorities. Once successfully reviewed and results understood for the adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy.
Till date, Axitinib has been extensively studied in a broad clinical development program, with a final result of efficient and safe results on more than 2,500 patients across several tumor types. Currently Axitinib is being reviewed by several regulatory agencies, including U.S. Food and Drug Administration (FDA), Japanese Ministry of Health, labour and welfare, European Medicines Agency and many more. If approved, Pfizer plans to commercialize axitinib for this indication.
SFJ Pharma Ltd. is a part of the SFJ Pharmaceuticals Group, which was formed in January' 2009. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies.
Salomon Azoulay, SVP, Medical & Development, Emerging Markets / Established products business units, Pfizer, will be presenting at Pharma Trials World Asia 2012 this March about "Pfizer's global clinical development strategy with collaborations in Asian powerhouses India & China". Dr. Sam will share his views about leveraging on clinical innovation in planning your emerging market strategy for effective clinical trials in Asia and also share his case study; "Implementing global trials in Asia – R&D strategies in India and China".