FDA has determined that Insmed's growth hormone treatment iPlex qualifies as a different product than Tercica's Increlex for the purpose of orphan drug designation.

IPlex (mecasermin rinfabate [rDNA origin] injection) received FDA approval Dec. 12 for the "treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH."

Tercica's competing product Increlex (mecasermin [rDNA origin] injection) was approved Aug. 30 for the same indication (¹ Also see "Tercica’s Growth Treatment Increlex Clears FDA With Orphan Drug Exclusivity" - Pink Sheet, 31 August, 2005.).

Both products received orphan drug exclusivity.

Once an orphan drug is approved, FDA will not approve the same drug for the same indication during the seven-year exclusivity period unless a subsequent product demonstrates a therapeutic advantage over the earlier product.

Although both products carry the same indication, FDA has found them to be different drugs; both iPlex and Increlex qualify as new molecular entities, according to FDA.

Insmed plans a launch for iPlex in the second quarter of 2006; Tercica has said it intends to launch Increlex in January.

An Insmed citizen petition citing safety concerns with Tercica's product was unsuccessful in blocking approval of Increlex. Tercica responded with an unfair business practices lawsuit against Insmed, filed Dec. 6 in San Francisco federal court.

-Elizabeth Walker

Insmed Growth Agent iPlex Joins Tercica's Increlex With Orphan Drug Designation

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