Archimedes Pharma says that European regulators have approved PecFent for breakthrough cancer pain as it pushes ahead with plans to mount a U.S. marketing effort--provided it wins a nod from the FDA.
Archimedes has toyed with the notion of going public, but opted instead to stay out of the soured public exchanges and raised $100 million last year for its commercial launch of the new pain therapy. Archimedes Pharma uses its nasal drug delivery system to deliver fentanyl in a "rapid but controlled manner."
"The grant of European marketing authorization for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain," said CEO Jeffrey Buchalter. "This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months."
Just a week ago Archimedes said that it had decided to set up its U.S. beachhead in Bedminster, NJ, with plans to hire 75 workers to push PecFent.
- see the Archimedes release for more info