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Last updated on April 16, 2014 at 5:31 EDT

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

September 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(R) (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 us to advance our
clinical development programs and deliver new cancer medicines to patients as efficiently
as possible around the world,” said Garry Nicholson, president and general manager, Pfizer
Oncology. “Non-small cell lung cancer remains a difficult disease to treat despite recent
advances, and Pfizer is evaluating dacomitinib in NSCLC across lines of therapy and a
range of histologies and molecular subtypes. By collaborating with SFJ on the continued
clinical development of dacomitinib in this patient population, we hope to more
immediately bring a new first-line therapy to patients in need.”

Dacomitinib is an oral, once-daily, small molecule inhibitor of HER-1 (EGFR), HER-2
and HER-4 tyrosine kinases. It is being evaluated by Pfizer in a comprehensive clinical
development program that includes two global, randomized Phase 3 clinical trials
investigating its safety and efficacy as a second-line and refractory treatment for NSCLC.
Dacomitinib has not been approved by any regulatory agency.

About the SFJ Pharmaceuticals Group
The SFJ Pharmaceuticals Group, which was formed in January of 2009 is a global drug
development group of companies, which provides a unique co-development partnering model
for some of the world’s top pharmaceutical and biotechnology companies. 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. SFJ is backed by
Abingworth, Clarus and Fintech, which are venture capital firms specializing in
bio-pharmaceutical development. Collectively these venture capital firms manage over USD
$2.5 billion in funding.

http://www.abingworth.com

SOURCE SFJ Pharmaceuticals


Source: PR Newswire