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

his FOB trial is the second of two planned for 2008 as part of Insmed's development of a portfolio of FOBs. In July 2008, the Company announced that a completed Phase I clinical trial had demonstrated the bioequivalence of INS-19, the Company's recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen(R), an FDA-approved G-CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion. Insmed intends to seek approval of INS-19 and INS-20 in the U.S. and launch the products on expiration of the relevant innovator patents, which is in 2013 for Neupogen(R) and 2015 for Neulasta(R).

The Follow-on Biologics Market

According to published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015. FOBs would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent. A recent econometric study by economist Dr. Robert J. Shapiro, former Under Secretary of Commerce in the Clinton Administration, found that "...generic versions of the top 12 categories of biologic treatments with patent protections that have expired or that are due to expire in the near future could save Americans $67 billion to $108 billion over 10 years and $236 billion to $378 billion over 20 years."

About INS-20

Pegylated recombinant human G-CSF is a chemically modified version of G-CSF in which a water soluble polymer called polyethylene glycol is attached to the protein. The pegylated protein has a prolonged biological activity after it is injected into the patient. This allows less frequent dosing for the patient compared to recombinant human G-CSF. The FDA approved version of this drug is Neulasta(R). INS-20 is Insmed's follow-on biologic version of Neulasta(R).

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process development and manuf
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SOURCE Insmed Inc.
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