Insmed CEO to Present at Congressional Briefing on Follow-On Biologics
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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 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 Insmed
Insmed Inc. is a biopharmaceutical company with unique protein process
development and manufacturing experience and a proprietary protein platform
aimed at niche markets with unmet medical needs. For more information, please
visit www.insmed.com.
Forward-Looking Statements
This release contains forward-looking statements which are made pursuant
to provisions of Section 21E of the Securities Exchange Act of 1934. Investors
are cautioned that such statements in this release, including statements
relating to planned clinical study design, regulatory and business strategies,
strategic alternatives, plans and objectives of management and growth
opportunities for existing or proposed products, constitute forward-looking
statements which involve risks and uncertainties that could cause actual
results to differ materially from those anticipated by the forward-looking
statements. The risks and uncertainties include, without limitation, risks
that strategic alternatives may never be consummated, product candidates may
fail in the clinic or may not be successfully marketed or manufactured, we may
lack financial resources to complete development of product candidates, the
FDA may interpret the results of studies differently than us, competing
products may be more successful, demand for new pharmaceutical products may
decrease, the biopharmaceutical industry may experience negative market
trends, our entrance into the follow-on biologics market may be unsuccessful,
our common stock could be delisted from The NASDAQ Capital Market and other
risks and challenges detailed in the Company's filings with the U.S.
Securities and Exchange Commission, including the Company's Annual Report on
Form 10-K for the year ended December 31, 2007. Readers are cautioned not to
place undue reliance on any forward-looking statements which speak only as of
the date of this release. The Company undertakes no obligation to publicly
release the results of any revisions to these forward-looking statements that
may be made to reflect events or circumstances that occur after the date of
this release or to reflect the occurrence of unanticipated events.
Investor Relations Contact:
Brian Ritchie - FD
212-850-5683
brian.ritchie@fd.com
Corporate Communications Contact:
John Procter - Gibraltar Associates
202-879-5808
jprocter@gibraltar-llc.com
SOURCE Insmed Inc.
Investors, Brian Ritchie of FD, +1-212-850-5683, brian.ritchie@fd.com; or
Corporate Communications, John Procter of Gibraltar Associates,
+1-202-879-5808, jprocter@gibraltar-llc.com, both for Insmed Inc.
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