RICHMOND, Va., Oct. 30 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today reported results for the third quarter and nine-months ended September 30, 2008.
Recent Company Highlights
-- Follow-on Biologics Program
-- Received approval from the United Kingdom's Medicines and
Healthcare products Regulatory Agency 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.
-- Received $3.0 million in cost recovery revenue in the third quarter
related to the expanded access program ("EAP") for
IPLEX(TM). The EAP in Italy to treat patients with Amyotrophic
Lateral Sclerosis ("ALS"), also known as Lou Gehrig's
Disease, currently includes 23 physicians and over 100 subjects have
-- Announced the presentation of clinical study results with Premacure
demonstrating IPLEX(TM) increased serum IGF-I levels into the normal
range in significantly premature infants. Premacure is developing
IPLEX(TM) as a potential treatment for Retinopathy of Prematurity
("ROP") via a Material Transfer Agreement with Insmed.
Based in part on the results of this study, Premacure intends to
initiate a phase II multicenter trial in the ROP indication during
the fourth quarter.
"We continue to execute on our business plan and efficiently advance
each of our key clinical programs," said Dr. Geoffrey Allan, President and
CEO of Insmed. "Our second FOB ca
|SOURCE Insmed Inc.|
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