FDA Approves Insmed Incorporated’s Orphan Drug, IPLEX, For The Treatment Of Severe Primary IGF-1 Deficiency; The First Once-Daily Therapy For The Treatment Of Severe Primary IFG-1 Deficiency

RICHMOND, Va.--(BUSINESS WIRE)--Dec. 12, 2005--Insmed Incorporated (NASDAQ: INSM) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, IPLEX is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.