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RICHMOND, Va., May 8 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq:
INSM), a developer of follow-on biologics (FOB) and biopharmaceuticals,
today reported results for the first quarter ended March 31, 2008.
Recent Company Highlights
-- Follow-on Biologics Program
-- Received regulatory approval from the United Kingdom's Medicines and
Healthcare products Regulatory Agency to initiate a clinical trial
for Insmed's most advanced FOB candidate, INS-19 (Granulocyte Colony
Stimulating Factor or G-CSF), a FOB of the FDA-approved product
Neupogen(R), which had U.S. sales of approximately $0.9 billion in
2007;
-- Received and completed questionnaire from the Chairman and Ranking
Member of the U.S. House of Representatives' Subcommittee on Health
on the possible development of legislation to establish a FOB
regulatory pathway and;
-- Participated in two FOB-focused events: the Center for Business
Intelligence's "Evaluate the Legislative, Economic and Scientific
Implications of the Industry Debate on: Biosimilars and Follow-On
Biologics", and the American Enterprise Institute Follow-On
Biologics Program.
-- IPLEX(TM)
-- All sites have been initiated, received Investigational Review Board
approvals and are actively recruiting trial participants in the
Phase 2 clinical trial for IPLEX(TM) in Myotonic Muscular Dystrophy
("MMD"). The trial presently has 50% of the required 60 patients
enrolled and:
-- Received $2.3 million in cost recovery revenue in the first quarter
related to the expanded access program ("EAP") for IPLEX(TM) in
Italy to treat patients with Amyotrophic Lateral Sclerosis ("ALS"),
also known as Lou Gehrig's Disease. The EAP currently includes 20
phys
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| SOURCE Insmed Inc. Copyright©2008 PR Newswire. All rights reserved |
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