Dendreon eyes late 2011 European cancer vaccine filing
pharmafile | January 10, 2011 | News story | Sales and Marketing | Cancer, Denreon, Provenge, cancer vaccine, sipuleucel, vaccines
Dendreon Group is to seek marketing authorisation in Europe for the world’s first immunotherapy cancer vaccine in late 2011 or early 2012.
The Seattle-based biotech company already has US approval for Provenge (sipuleucel-T) and hopes for a European nod in the first half of 2013.
Dendreon will attempt to persuade the European Medicines Agency using clinical data from the IMPACT study, and plans to produce Provenge through a contract manufacturing organisation while it builds a facility in Europe.
Revenue from the drug in the US during 2010 reached $48 million, although analysts have forecast peak sales as high as $1 billion a year.
The brand is currently licensed for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
It works by removing cells from patients, modifying them and then re-introducing them to activate an immune response.
Unsurprisingly, Dendreon wants to extend the drug into new therapy areas: last month it filed an investigational new drug application with the FDA for the treatment of invasive bladder cancer.
It will enroll 180 patients with HER2+ invasive transitional cell carcinoma of the bladder following cystectomy in a randomised phase II study, whose primary endpoint is to evaluate overall survival.
“Last year was foundational for Dendreon with the successful introduction of Provenge as the world’s first autologous cellular immunotherapy,” said chief executive Mitchell Gold.
The company has increased its US sales force to 100 reps ahead of what it says will be a ten-fold increase in capacity from its facilities in New Jersey, Los Angeles and Atlanta this year.
“We are positioned for significant growth with our increased capacity in the US, our European strategy for filing now set and our progress in advancing our ACI pipeline in bladder cancer,” Gold added.
Other companies in the field will be hoping that Provenge’s progress makes its own products more acceptable to the market, persuading big pharma to invest in development.
Among these is Oxford BioMedica, whose own cancer vaccine TroVax received a setback in 2009 when Sanofi-Aventis pulled out of a development deal after it failed to prove its worth in phase III trials.
Adam Hill
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