EC grants orphan status to Tercica's Increlex

The European Commission has granted US drugmaker Tercica's Increlex (mecasermin [rDNA origin] injection) Orphan Medicinal Product status for the treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects.

John Scarlett, Tercica chief executive, said he hopes to bring the drug to children in the European Union by 2007, "subject to timely regulatory approval." Increlex was cleared for severe Primary IGFD by the US Food and Drug Administration on August 30, 2005, and has received US Orphan Drug status for this indication.

The latest designation, which grants Tercica market exclusivity in the EU for 10 years after approval, is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency. The goal of the EU's OD designation is to advance the innovation of drugs for rare diseases, classed as disorders that affect no more than five in 10,000 citizens of the community.