Pfizer stakes a claim in plant cell–made biopharmaceuticals
On December 1, Pfizer became the first big pharma to commit to take to market a late-stage biologic drug produced in plant cells. It acquired rights to taligurase alfa, a form of the enzyme glucocerebrosidase in development for the treatment of Gaucher’s disease, from Protalix Biotherapeutics in Carmiel, Israel. Protalix has completed phase 3 studies and has submitted a new drug application for the drug, also known as prGCD, eyeing US marketing approval in 2010. At the request of the US Food and Drug Administration (FDA) last year, the company has already begun supplying prGCD to patients in the US under an expanded access program and similarly to patients in the EU under a compassionate-use protocol [my emphasis - Ed].
Very interesting development, this: while Bayer led the way in acquiring plant expression vector maestros Icon Genetics a couple of years ago, there has not been much interest by Bigger Pharma in getting hold of the plant-expressed biologics startups – but expect things to change, starting now.
Ratner goes on, quoting Yuri Gleba of Icon / Bayer:
…Icon’s Gleba acknowledges that Protalix’s success in product development with prGCD shows they have a keen business sense. “If you are not strong on one side you have to compensate by being excellent on another, and by all accounts, they are,” he says. The deal with Pfizer and the approval of prGCD “should open the floodgates, in my opinion,” he says. “It is by far the most significant development in the plant-made pharmaceuticals arena right now.”
The floodgates are opening; Big Pharma is at the door – finally!