Antigenics has spent hundreds of millions of dollars on the late-stage development of the cancer vaccine Oncophage, but its CEO tells Mass High Tech that the FDA's mindset on cancer drug development would prohibit the agency from ever approving the therapy.
"Not unless the agency significantly changes," CEO Garo Armen (photo) told the pub. "The Western regulatory bureaucracies are too rigid to know how to deal with our product... The easiest thing for us right now would be to abandon Oncophage, but we have a moral responsibility."
Antigenics was forced to cut about a third of its staff last year. So far, Russia has been the only country to approve the cancer vax. European regulators rejected it last fall and Armen says that the company is in talks to see if it can map out a path to approval in Europe.
Mass High Tech says the developer could have been ahead of its time, but Antigenics has also been repeatedly ridiculed for its statements on Oncophage. TheStreet's Adam Feuerstein, in particular, has cited the company for its "dubious" Oncophage data, noting that the drug failed a late-stage trial and only looked promising after retrospective data mining analysis was done. Armen's decision to spurn the FDA only occurred after it became clear that the company never had a chance to win an approval based on the data it holds.
- here's the Mass High Tech piece