Protalix BioTherapeutics drug candidate gets recommendation for special status in Europe
By APWednesday, January 13, 2010
Protalix drug recommended for special status
NEW YORK — Protalix BioTherapeutics Inc. said Wednesday a panel recommended that European regulators give the company’s developing Gaucher disease drug orphan drug status.
Taliglucerase alfa, or Uplyso, is aimed at treating Gaucher, which is a rare enzyme disorder that can cause liver and neurological problems. Orphan drug status is given to drugs that treat rare diseases, and comes with benefits including long-lasting marketing exclusivity.
The European Medicines Agency still has to approve the designation, but normally follows the advice of its panels. The drug candidate already has similar status in the U.S.
In November, Protalix struck a licensing deal with Pfizer Inc. worth up to $115 million. That deal gives Pfizer worldwide rights, except in Israel, to sell Uplyso.
Shares of Protalix, which is based in Israel, rose 12 cents to $7.58 in morning trading.
