Tercica, Inc announced that the European Commission has granted marketing authorization for Increlex (mecasermin) 10 mg/ml solution for injection. The authorized indication is for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
The Orphan Drug designation that Increlex received for the authorized indication will provide ten years of marketing exclusivity in the European Union. Ipsen (Euronext:IPN) is Tercica's marketing partner for Increlex in the European Union.
As a result of this marketing authorization, Tercica will receive a milestone payment of EUR 15 million (approximately U.S. $20 million) from Ipsen under the companies' licensing agreement, and following any necessary local pricing reviews, Ipsen will launch Increlex in the European Union.
"We are excited to bring the first treatment innovation in the short stature field since growth hormone, initially to the United States and today to the European Union," said Dr John A. Scarlett, Tercica's president and CEO. "Our collaboration with Ipsen provides us with a very strong partner to commercialise Increlex in the European Union and together we look forward to providing this important medical advance to the children in the European Union suffering from severe Primary IGFD," added Dr Scarlett.
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 IGFD, 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. Severe Primary IGFD is defined by: height standard deviation score less than or equal to -3.0, basal IGF-1 levels below the 2.5th percentile for age and gender, GH sufficiency, and exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism or chronic treatment with pharmacologic doses of anti-inflammatory steroids. In children with this disorder, low IGF-1 levels are due to growth hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression.