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Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs
Date:4/29/2008

- Company on Schedule to Have Two Follow-on Biologics in Clinical Studies

by Year-End

- Enrollment On Track in MMD Clinical Study

- ALS Expanded Access Program Continues to Enroll - Insmed Generates $2.3 million in Cost Recovery Revenue Through Expanded

Access Program for IPLEX(TM) in Italy

RICHMOND, Va., April 29 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOBs) and biopharmaceuticals, today provided an update of the status of its initial FOB development candidates, INS-19 (a FOB of Neupogen(R)) and INS-20 (a FOB of Neulasta(R)) which represent combined 2007 sales of over $4 billion. The Company also reported recent progress made with its IPLEX(TM) development program.

Follow-On Biologics Program

Insmed recently received regulatory approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a clinical trial for Insmed's most advanced FOB candidate, INS-19. Pre-clinical pharmacological, pharmacokinetic and toxicological studies have demonstrated that INS-19 and FDA-approved Neupogen(R) are comparable, and detailed analytical characterisation has also demonstrated that the products have a high degree of similarity. Screening for participants for the Phase 1 study has begun, with dosing of the first patient expected in May 2008. Data to support human similarity is expected in July 2008.

Insmed's second FOB product candidate, INS-20, has also completed pre- clinical pharmacological and pharmacokinetic studies, which have demonstrated that INS-20 and FDA-approved Neulasta(R) are comparable. Detailed analytical characterisation has also demonstrated that the products have a high degree of similarity. The Company intends to initiate clinical studies for INS-20 in the fourth quarter of 2008.

Insmed also has several other FOB products which are currently at
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SOURCE Insmed Inc.
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