Tercica Finishes First With Increlex Orphan Approval; Insmed Left In Dust?
Executive Summary
FDA will decide a battle for orphan drug exclusivity in the extreme short stature market between Tercica's Increlex and Insmed's SomatoKine if and when Insmed's agent is approved, Tercica predicted
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Insmed Growth Agent iPlex Joins Tercica’s Increlex With Orphan Exclusivity
Insmed is focusing on the dosing schedule of its growth hormone treatment iPlex to distinguish it from Tercica's competing product Increlex
Insmed Growth Agent iPlex Joins Tercica’s Increlex With Orphan Exclusivity
Insmed is focusing on the dosing schedule of its growth hormone treatment iPlex to distinguish it from Tercica's competing product Increlex
Tercica v. Insmed
Tercica filed an unfair business practices suit Dec. 6 in San Francisco federal court alleging that Insmed engaged in false and deceptive practices and promotions in claiming that Tercica's growth therapy Increlex is unsafe and that its own investigational therapy iPlex is safer. The lawsuit is the latest step in a competitive showdown between the two companies and comes as the Dec. 12 user fee date for iPlex (mecasermin rinifibate) approaches. Increlex (mescasermin [rDNA origin]) cleared FDA in August with seven years of orphan drug exclusivity (1"The Pink Sheet" Sept. 5, 2005, p. 19). In addition to monetary relief, Tercica requests that the court stop Insmed from making false statements and order the company to publicly correct alleged misrepresentations. Insmed said the suit is unwarranted...