Insmed Provides Update on IPLEX(TM) Programs
21 Juillet 2008 - 2:00PM
PR Newswire (US)
-- MMD Phase 2 Trial Fully Enrolled -- RICHMOND, Va., July 21
/PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq CM: INSM), a
developer of follow-on biologics (FOBs) and biopharmaceuticals,
today provided an update on the status of its IPLEX(TM) development
program. Insmed's Phase 2 trial of IPLEX(TM) in Myotonic Muscular
Dystrophy (MMD), which was initiated in December 2007, has seen a
strong patient and physician interest and is now fully enrolled.
The trial is a six month, randomized, double-blind,
placebo-controlled trial conducted at 13 research centers across
the USA. The trial endpoints include the six-minute walk test, an
FDA-accepted measure of endurance, and various conventional
measures of muscle function, muscle strength, cognitive function,
gastrointestinal function, general health, pain, insulin
sensitivity, safety and tolerability As previously announced, a
substantial portion of the external costs associated with the study
are expected to be covered by an approximately $2.1 million grant
awarded to Insmed by the Muscular Dystrophy Association in late
2007. IPLEX(TM) also continues to be used as part of an Expanded
Access Program (EAP) in partnership with the Italian Ministry of
Health for the treatment of Amyotrophic Lateral Sclerosis (ALS), or
Lou Gehrig's disease. Additional subjects are being enrolled as the
program progresses and IPLEX(TM) continues to demonstrate that it
is safe and well tolerated in the subject population. To date the
EAP has grown to include 22 physicians, and approximately 100
patients have been enrolled in the program. During the second
quarter of 2008, cost recovery revenue from the EAP is expected to
be approximately $2.6 million as compared to $1.2 million during
the same period last year and $2.3 million in the first quarter of
2008. For the first half of 2008, Insmed expects the EAP to
generate approximately $4.9 million in cost recovery revenue,
compared to $1.9 million in the first half of 2007 and $5.4 million
generated during the whole of 2007. About Myotonic Muscular
Dystrophy Myotonic muscular dystrophy (MMD), also known as myotonic
dystrophy, dystrophia myotonica or Steinert's disease, is the most
common type of adult muscular dystrophy, affecting 1 in 8000
individuals (approximately 37,000 people in the United States).
Myotonic dystrophy patients develop progressive muscle wasting and
weakness in the hands, forearms, legs, neck and face, as well as
cataracts and cardiac arrhythmias, and eventually can become
totally disabled, dying usually from respiratory or cardiac
failure. At present, there is no treatment to reverse most of these
symptoms. For more information about myotonic muscular dystrophy,
please visit http://www.mda.org/ . About Amyotrophic Lateral
Sclerosis Amyotrophic Lateral Sclerosis (ALS), often referred to as
Lou Gehrig's disease, is a progressive neurodegenerative disease
that attacks nerve cells in the brain and spinal cord resulting in
muscle weakness and atrophy. The life expectancy of an ALS patient
averages about two to five years from the time of diagnosis. For
more information about ALS visit http://www.alsa.org/ . About
IPLEX(TM) IPLEX(TM) is a complex of recombinant human insulin-like
growth factor-I (rhIGF-I) and its predominant binding protein
IGFBP-3 (rhIGFBP-3). The drug, approved in the United States in
December 2005 for the treatment of children with growth failure due
to severe primary IGF-I deficiency, is currently being investigated
in MMD and ALS. 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 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,
the FDA may not establish specific guidelines for a pathway for the
approval of FOB products, FOB products may not be accepted by
consumers, 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 CONTACT: Investor
Relations, Brian Ritchie, of FD, +1-212-850-5683, ; or Corporate
Communications, John Procter, of Gibraltar Associates,
+1-202-879-5808, , both for Insmed Web site: http://www.insmed.com/
http://www.mda.org/ http://www.alsa.org/
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