Insmed Announces Initiation of Phase II Clinical Trial with IPLEX(TM) in Myotonic Muscular Dystrophy



    Promising Results Observed in Ongoing Open Label Trial

    RICHMOND, VA., November 5 /CNW/ - Insmed Inc. (Nasdaq:  INSM), a
biopharmaceutical company focused on the development and approval of drugs for
the treatment of metabolic diseases with unmet medical needs, today announced
the planned initiation of a 24-week, multi-center, randomized, double blind,
placebo-controlled Phase II clinical trial with IPLEX(TM) in patients with
Myotonic Muscular Dystrophy. The decision to initiate this trial is based on
the promising results from an ongoing open-label, dose-escalation trial of
IPLEX(TM) in this indication.

    Up to 70% of the patients analyzed in an ongoing open-label,
dose-escalation trial have reported improvement in one or more of several
symptoms commonly associated with Myotonic Muscular Dystrophy, including
cognitive function, gastrointestinal function, muscle pain, arm and leg
strength, fatigue and endurance. Specific assessment of endurance demonstrated
an improved performance in the six minute walk test, a well accepted FDA
approval end point. Improvements in endurance were comparable to other drugs
approved where this test was used for FDA approval. The six minute walk test
is a well accepted, validated, quantitative measure of endurance and has been
used as a primary endpoint in pivotal studies of several FDA approved drugs.

    The purpose of the Phase II study is to confirm the positive results
obtained in the open-label dose escalation trial in a multi-center,
randomized, double-blind, placebo-controlled setting. The study will include
60 patients and will be powered to detect a 75 meter difference between
IPLEX(TM) and placebo for the change in distance walked during the six minute
walk test. The results from this Phase II study will be used to establish the
design for Phase III clinical development.

    Dr. Geoffrey Allan, Ph.D., Insmed's President and Chief Executive
Officer, said, "We are very excited by our initial observations with IPLEX(TM)
in the management of this major debilitating condition where there is no
effective treatment and we are extremely pleased to announce the initiation of
this expanded study. Provided the results of this confirmatory clinical trial
replicate those of the ongoing, open-label, dose-escalation study, we believe
we will be able to rapidly move IPLEX(TM) into Phase III development for
Myotonic Muscular Dystrophy, an indication which we believe represents a
significant market opportunity for the company."

    About Insmed Incorporated

    Insmed is a biopharmaceutical company focused on the development of drug
candidates for the treatment of metabolic diseases and endocrine disorders
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,
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 Global Market and other
risks and challenges detailed in our filings with the U.S. Securities and
Exchange Commission, including our Quarterly Report on Form 10-Q for the
quarter ended June 30, 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.




For further information:

For further information: Investor Relations International Haris Tajyar,
818-382-9702 htajyar@irintl.com

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