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The SFJ Pharmaceuticals Group Announces Agreement With Pfizer to Co-develop Dacomitinib as First-Line Treatment for Patients With Advanced Non-small Cell Lung Cancer
Date:9/7/2012

SAN FRANCISCO, September 7, 2012 /PRNewswire/ --

Phase 3 Trial to be Conducted Across Sites in Asia and Europe

The SFJ Pharmaceuticals Group (SFJ), announced today that it has entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase 3 clinical trial of Pfizer's investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804).  The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).

Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations.  If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.

This is the second collaborative agreement between SFJ and Pfizer.  SFJ previously entered into an agreement with Pfizer to conduct a Phase 3 trial in Asia of Pfizer's Inlyta® (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.

"At SFJ, our mission is to accelerate the availability of new and innovative drugs into the world's major markets through co-development," said Robert DeBenedetto, SFJ's President & CEO.  "With this important, multi-national trial, we are pleased to continue our collaborative relationship with Pfizer and support the clinical development of a promising new agent for the treatment of lung cancer."

"Pfizer is committed to building innovative partnerships that enable u
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SOURCE SFJ Pharmaceuticals
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