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news.The European Commission has granted Tercica marketing authorization for Increlex 10mg/ml solution for injection, for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency.
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The orphan drug designation that Increlex received for the authorized indication will provide 10 years of marketing exclusivity in the EU. As a result of this marketing authorization, Tercica will receive a milestone payment of E15 million (approximately $20 million) from marketing partner Ipsen under the companies’ licensing agreement. Following any necessary local pricing reviews, Ipsen will launch Increlex in the EU.
The active ingredient of Increlex is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone’s (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In primary insulin-like growth factor-1 deficiency, children’s serum IGF-1 levels are low, despite the presence of normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height.