Marching toward the front line
PLEASANTON, Calif.—In what the In-Vivo Blog touted as one of its "Deals of the Week" on Sept. 7, the SFJ Pharmaceuticals Group (SFJ) announced today that it has entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase III clinical trial of Pfizer's investigational panhuman epidermal growth factor receptor (pan-HER) inhibitor, dacomitinib, also designated as PF-00299804.
Looking toward use of 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), the trial will be conducted across multiple sites in Asia and Europe.
It's not the first go-round for the two companies, as SFJ, a San Francisco-area company, had previously entered into an agreement in January with Pfizer to conduct a Phase III trial in Asia of Pfizer's Inlyta (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.
Under the terms of this latest deal, SFJ will provide the funding and clinical development supervision to generate the clinical data that Pfizer will need to support its registration dossier on dacomitinib for marketing authorization by regulatory authorities for the NSCLC indication. Should the agent be approved for that, SFJ will be eligible to receive unspecified milestone payments and earn-out payments.
As Robert DeBenedetto, SFJ's president and CEO, notes, "At SFJ, our mission is to accelerate the availability of new and innovative drugs into the world's major markets through co-development. With this important, multinational 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."
Dacomitinib is an oral, once-daily, small-molecule inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. Pfizer is evaluating the compound in a comprehensive clinical development program that includes two global, randomized Phase III clinical trials investigating its safety and efficacy as a second-line and refractory treatment for NSCLC. Dacomitinib has not yet been approved by any regulatory agency.
"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 of Pfizer Oncology, when the agreement was announced. "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."
SFJ is still a relatively young company, formed in January 2009 as a global drug development group of companies providing what it calls "a unique co-development partnering model for some of the world's top pharmaceutical and biotechnology companies." SFJ notes that it 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 biopharmaceutical development. Collectively, these venture capital firms manage more than $2.5 billion in funding.