AsianScientist (Jan. 10, 2012) – SFJ Pharma Ltd. announced yesterday that it has entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase III clinical trial in Asia of Pfizer’s investigational agent axitinib for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, receptors that can influence tumor growth, vascular angiogenesis, and progression of cancer. It has been widely studied in a broad clinical development program, evaluating its efficacy and safety in more than 2,500 patients across several tumor types.
Axitinib is currently under review by the U.S. Food and Drug Administration, the European Medicines Agency, the Japanese Ministry of Health, Labour and Welfare, and several other regulatory agencies around the world as a treatment for advanced RCC.
Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to submit axitinib for review by regulatory authorities for the adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy. SFJ will be eligible to receive milestone payments under the agreement.
In addition, if approved, Pfizer intends to commercialize axitinib for this indication and SFJ will receive earn-out payments under the agreement.
“We appreciate the opportunity to collaborate with Pfizer for one of their most promising oncology compounds,” said SFJ Pharma. Ltd. President & CEO of Robert DeBenedetto.
“We believe SFJ’s new co-development model will benefit patients by allowing Pharma companies like Pfizer to develop even more compounds simultaneously.”
Axitinib is also being investigated in a randomized Phase III clinical trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized Phase II clinical trial for the treatment of hepatocellular carcinoma (HCC).
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Source: SFJ Pharmaceuticals, Inc.
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