Insmed Incorporated (INSM) Issues Statement Regarding IPLEX(TM) Approvable Letter Press Release
10/19/2005 5:13:08 PM
RICHMOND, Va.--(BUSINESS WIRE)--Sept. 29, 2005--Insmed Incorporated (NASDAQ:INSM) today released the following statement: The company wishes to clarify a statement in the press release issued September 27, 2005 regarding iPlex (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate). With respect to the orphan exclusivity issue, Insmed wants to be clear that the FDA has not yet determined whether the recent approval and granting of orphan exclusivity for Mecasermin (rDNA origin) for Severe Primary IGF-1 deficiency will block the approval of iPlex. The Agency is still considering the issue.