Insmed Selected to Complete Congressional Questionnaire Regarding the Potential Establishment of a Follow-On Biologics Regulator
10 Avril 2008 - 2:00PM
PR Newswire (US)
RICHMOND, Va., April 10 /PRNewswire-FirstCall/ -- Insmed Inc.
(NASDAQ:INSM), a developer of follow-on biologics and
biopharmaceuticals, today announced receipt of a letter and
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 Follow-On Biologics
(FOBs) regulatory pathway. Sent to approximately 30 stakeholders in
the biotechnology industry, healthcare and patient communities, the
letter notes that the " ... Members of the Subcommittee on Health
are committed to this issue" and has requested Insmed's input "to
better evaluate the merits, benefits, and costs of a biosimilars
bill ... " Included in the letter for response are six pages of
questions covering a range of related issues, including science,
potential economic impact, incentives, and innovation. Insmed
intends to submit responses to the Subcommittee in advance of the
April 22, 2008 deadline. "We are very pleased that Insmed has been
selected by the Subcommittee for input on this important issue,"
said Geoffrey Allan, Ph.D., CEO of Insmed. "We are pleased to be at
the forefront of this critical healthcare initiative, look forward
to submitting our thoughts and welcome the Member's commitment to
adopt legislation so patients can readily receive affordable access
to life-saving biotechnology drugs." Insmed is currently developing
a portfolio of FOBs and intends to initiate clinical trials for its
first two FOBs in 2008, both of whose brand sales represent over $3
billion in current sales worldwide. Members of Insmed's skilled
biologics team have worked on the development of over 50
therapeutic proteins. Their focused protein-based drug development
backgrounds, coupled with the Company's FDA-approved protein
manufacturing facility, and clinical and regulatory expertise,
positions Insmed, upon the establishment of a regulatory pathway,
to be an initial entrant into the U.S. FOBs market following the
expiration of patents covering certain innovator products. 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. Insmed has a state-of-the- art, FDA-approved
biologic commercial manufacturing facility in Boulder, Colorado and
a corporate office in Richmond, Virginia. For more information,
please visit http://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, 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 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 our filings with the U.S.
Securities and Exchange Commission, including our 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. We
undertake 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
Corporate Communications Contact: John Procter- Gibraltar
Associates 202-879-5808 DATASOURCE: Insmed Inc. CONTACT: Investor
Relations Contact, Brian Ritchie, FD, +1-212-850-5683, ; Corporate
Communications Contact, John Procter, Gibraltar Associates,
+1-202-879-5808, Web site: http://www.insmed.com/
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