Tercica and Ipsen received European marketing authorization for Increlex® for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency.
Tercica will receive a milestone payment of EUR 15 million, or approximately $20.55 million, from its EU marketing partner, Ipsen. Since Increlex is under orphan drug designation, the drug will have a 10-year exclusivity period in the EU. It will be sold as a 10-mg/mL solution.
Tercica has been marketing Increlex in the U.S. since early 2006. The drug’s active ingredient is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone’s effect on statural growth and must be present for normal growth of bones and cartilage in children.