Marching toward the front line

SFJ and Pfizer to co-develop dacomitinib as first-line treatment for patients with advanced non-small cell lung cancer

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PLEASANTON, Calif.—In what theIn-Vivo Blog touted as one of its "Deals of the Week" on Sept. 7,the SFJ Pharmaceuticals Group (SFJ) announced today that it hasentered into a collaborative development agreement with Pfizer Inc.to conduct a Phase III clinical trial of Pfizer's investigationalpanhuman epidermal growth factor receptor (pan-HER) inhibitor,dacomitinib, also designated as PF-00299804.
 
Looking toward use of dacomitinib as afirst-line treatment for patients with locally advanced or metastaticnon-small cell lung cancer (NSCLC) with activating mutations ofepidermal growth factor receptor (EGFR), the trial will be conductedacross multiple sites in Asia and Europe.

It's not the first go-round for thetwo companies, as SFJ, a San Francisco-area company, had previouslyentered into an agreement in January with Pfizer to conduct a PhaseIII trial in Asia of Pfizer's Inlyta (axitinib) for the adjuvanttreatment of patients at high risk of recurrent renal cell carcinomafollowing nephrectomy.

Under the terms of this latest deal,SFJ will provide the funding and clinical development supervision togenerate the clinical data that Pfizer will need to support itsregistration dossier on dacomitinib for marketing authorization byregulatory authorities for the NSCLC indication. Should the agent beapproved for that, SFJ will be eligible to receive unspecifiedmilestone payments and earn-out payments.

As Robert DeBenedetto, SFJ'spresident and CEO, notes, "At SFJ, our mission is to accelerate theavailability of new and innovative drugs into the world's majormarkets through co-development. With this important, multinationaltrial, we are pleased to continue our collaborative relationship withPfizer and support the clinical development of a promising new agentfor the treatment of lung cancer."

Dacomitinib is an oral, once-daily,small-molecule inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosinekinases. Pfizer is evaluating the compound in a comprehensiveclinical development program that includes two global, randomizedPhase III clinical trials investigating its safety and efficacy as asecond-line and refractory treatment for NSCLC. Dacomitinib has notyet been approved by any regulatory agency.

"Pfizer is committed to buildinginnovative partnerships that enable us to advance our clinicaldevelopment programs and deliver new cancer medicines to patients asefficiently as possible around the world," said Garry Nicholson,president and general manager of Pfizer Oncology, when the agreementwas announced. "Non-small cell lung cancer remains a difficultdisease to treat despite recent advances, and Pfizer is evaluatingdacomitinib in NSCLC across lines of therapy and a range ofhistologies and molecular subtypes. By collaborating with SFJ on thecontinued clinical development of dacomitinib in this patientpopulation, we hope to more immediately bring a new first-linetherapy to patients in need."

SFJ is still a relatively youngcompany, formed in January 2009 as a global drug development group ofcompanies providing what it calls "a unique co-developmentpartnering model for some of the world's top pharmaceutical andbiotechnology companies." SFJ notes that it uses its financialstrength and core team of pharmaceutical development experts toprovide highly customized partnering models in which SFJ provides thefunding and clinical development supervision necessary to obtainregulatory approval for "some of the most promising drugdevelopment programs of pharmaceutical and biotechnology companies."SFJ is backed by Abingworth, Clarus and Fintech, which are venturecapital firms specializing in biopharmaceutical development.Collectively, these venture capital firms manage more than $2.5billion in funding.




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