Insmed Selected to Complete Congressional Questionnaire Regarding the Potential Establishment...

Insmed Selected to Complete Congressional Questionnaire Regarding the
Potential Establishment of a Follow-On Biologics Regulatory Pathway

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
brian.ritchie@fd.com

Corporate Communications Contact:
John Procter- Gibraltar Associates
202-879-5808
jprocter@gibraltar-llc.com

SOURCE Insmed Inc.

Investor Relations Contact, Brian Ritchie, FD, +1-212-850-5683,
brian.ritchie@fd.com; Corporate Communications Contact, John Procter,
Gibraltar Associates, +1-202-879-5808, jprocter@gibraltar-llc.com