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CEO Geoffrey Allan Will Stress the Importance to Patients of Passing a
Follow- On Biologics Approval Pathway
RICHMOND, Va., July 22 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq CM: INSM) a developer of follow-on biologics and biopharmaceuticals, today announced that Geoffrey Allan, Ph.D., CEO of Insmed, will present at a Congressional briefing on Friday, July 25th, 2008 to discuss the significant need for establishing an approval pathway for follow-on biologics (FOB) and share recent company developments.
The briefing, entitled "The Future of Medicine: How to Lower Costs and Improve Patient Access with Generic Biologics," will be held at the U.S. Capitol Complex in Washington, D.C. Dr. Allan will detail Insmed's unique capabilities related to the development of follow-on biologics. Specifically, he will discuss the Company's latest developments, including release of Phase I data demonstrating the bioequivalence of Insmed's first FOB candidate, INS- 19, to Amgen's Neupogen(R) (patent expiration in 2013), the Company's affiliation with The Honorable Bill Thomas and the benefits of potential price competition and increased innovation in the field of biotechnology.
Insmed intends to request a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19. The Company also plans to initiate a Phase I trial for Insmed's second follow-on biologic product, INS-20, a follow-on of Neulasta(R) (patent expiration in 2015) in the fourth quarter of 2008. The two approved biologics represented combined 2007 worldwide sales of over $4 billion. Insmed plans to launch its follow-on biologic versions of these drugs on expiration of the relevant innovator patents.
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 effec
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