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Insmed Initiates Clinical Study for Follow-on Biologic Version of Neulasta(R)
Date:10/14/2008

Company's INS-20 Receives Regulatory Clearance to Begin Phase I Clinical Trial

RICHMOND, Va., Oct. 14 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical study for the Company's second follow-on biologic (FOB) product candidate, INS-20. Insmed's INS-20 is a pegylated recombinant form of human G-CSF, and an FOB of the FDA-approved product Neulasta(R), which had U.S. sales of approximately $2.4 billion in 2007.

Pre-clinical studies demonstrated that INS-20 and FDA-approved Neulasta(R) are comparable in both their pharmacological and toxicological profile. Detailed analytical characterisation also demonstrated that the products have a high degree of similarity. Data from these initial evaluations have been used, in part, to support the Phase I study, which will be initiated immediately. The Phase I study will be conducted in the United Kingdom and will compare the safety and establish the bioequivalence of INS-20 to Neulasta(R). Results from the trial are anticipated in 2009, and are expected to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial.

"We continue to be pleased by the progress we are making in the development of our FOB portfolio, utilizing our unique protein drug development capabilities and technical expertise," said Dr. Geoffrey Allan, President and CEO of Insmed. "Each development milestone we achieve is further evidence of our strong position as a leader in this evolving industry. We intend to use the data to be generated from the Phase I trial, in combination with the positive pre-clinical results previously garnered, as the basis for discussions with the FDA in an effort to establish a Phase III development path for INS-20."

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