Pfizer, SFJ to conduct axitinib Phase 3 trial in renal cell carcinoma

SFJ Pharma Ltd. II (President & CEO: Robert F. DeBenedetto, "SFJ") announced today that it has entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase 3 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 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."

"We recognize the need to look for new and innovative ways to advance our clinical programs and bring our many promising compounds to patients with speed and quality, wherever they are in the world," said Garry Nicholson, president and general manager, Pfizer Oncology. "We are pleased to be collaborating with SFJ on the continued clinical development of axitinib, and in doing so hope to bring a new adjuvant therapy to patients with this disease."

Axitinib is also being investigated in a randomized Phase 3 clinical trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized Phase 2 clinical trial for the treatment of hepatocellular carcinoma (HCC).

SOURCE SFJ Pharma