Insmed Sues Tercica for False Advertising
16 Octobre 2006 - 10:15PM
Business Wire
Insmed Incorporated (NASDAQ:INSM) announced today that it has sued
Tercica, Inc. for allegedly false and misleading statements Tercica
has made in advertising and promoting Increlex�, Tercica�s Severe
Primary IGFD treatment. In a counterclaim filed in the United
States District Court for the Eastern District of Virginia, Insmed
charges that Tercica has made numerous unlawful, false and
misleading statements Increlex and/or IPLEX�, the only once daily
treatment for children with short stature associated with severe
primary IGF-I deficiency (Primary IGFD). At issue are statements
made by Tercica that Insmed believes are likely to mislead
customers into believing that Increlex is a superior choice in
Primary IGFD treatments. Those statements include
misrepresentations that Increlex is the most convenient, stable and
easy-to-handle Primary IGFD treatment; false statements that IPLEX
requires �special equipment� or �elaborate thawing� procedures;
statements that falsely minimize concerns about the incidence of
severe hypoglycaemia during treatment with an IGF-1 drug (in
contrast to Tercica�s admissions to the FDA); and unfair and
misleading price comparisons, which misrepresent the relative costs
of using Increlex and IPLEX. Insmed seeks an injunction barring
Tercica from making these misrepresentations, an order compelling
Tercica to recall its false advertisements and issue corrections,
and an award of profits, damages, and attorney�s fees and costs.
Insmed�s counterclaim is part of its response to false advertising
claims that Tercica brought against Insmed in June. Portions of
those claims were dismissed by the Court earlier this month. The
matter is scheduled for trial in March. About IPLEX IPLEX is
approved in the United States as the only once daily treatment for
children with short stature associated with severe primary IGF-I
deficiency (Primary IGFD). IPLEX, a complex of recombinant human
IGF-I and its binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the
only FDA-approved IGF-I replacement therapy that also replaces
deficient IGFBP-3 in these patients. The drug, which was launched
in the second quarter of 2006, is also being investigated for
various other indications with unmet medical needs, including
severe insulin resistance, myotonic muscular dystrophy and HIV
Associated Adipose Redistribution Syndrome (HARS). For more
information about IPLEX please go to www.go-IPLEX.com. About Insmed
Insmed is a biopharmaceutical company focused on the development
and commercialization of drugs for the treatment of metabolic
diseases and endocrine disorders with unmet medical needs. For more
information, please visit www.insmed.com. Forward Looking
Statements Statements included within this press release, which are
not historical in nature, may constitute forward-looking statements
for the purposes of the safe harbor provided by the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the pending litigation and or future ability
to conduct our business as now conducted and as it is currently
proposed to be conducted. Such forward-looking statements are
subject to numerous risks and uncertainties, including but not
limited to the uncertainty of the outcome of any litigation with
Tercica, the risk that product candidates may fail in the clinic or
may not be successfully marketed or manufactured, the company may
lack financial resources to complete development of product
candidates or the FDA or other regulatory agencies may interpret
the results of our studies differently than we have. We can give no
assurances that we would be successful in any litigation or that
such litigation would not have a material adverse effect on our
business, financial condition and results of operation.
Furthermore, we may not be able to afford the expense of defending
against such a claim. As a result of these and other risks and
uncertainties, actual results may differ materially from those
described in this press release. For further information with
respect to factors that could cause actual results to differ from
expectations, reference is made to reports filed by the Company
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. Insmed Incorporated (NASDAQ:INSM)
announced today that it has sued Tercica, Inc. for allegedly false
and misleading statements Tercica has made in advertising and
promoting Increlex(TM), Tercica's Severe Primary IGFD treatment. In
a counterclaim filed in the United States District Court for the
Eastern District of Virginia, Insmed charges that Tercica has made
numerous unlawful, false and misleading statements Increlex and/or
IPLEX(TM), the only once daily treatment for children with short
stature associated with severe primary IGF-I deficiency (Primary
IGFD). At issue are statements made by Tercica that Insmed believes
are likely to mislead customers into believing that Increlex is a
superior choice in Primary IGFD treatments. Those statements
include misrepresentations that Increlex is the most convenient,
stable and easy-to-handle Primary IGFD treatment; false statements
that IPLEX requires "special equipment" or "elaborate thawing"
procedures; statements that falsely minimize concerns about the
incidence of severe hypoglycaemia during treatment with an IGF-1
drug (in contrast to Tercica's admissions to the FDA); and unfair
and misleading price comparisons, which misrepresent the relative
costs of using Increlex and IPLEX. Insmed seeks an injunction
barring Tercica from making these misrepresentations, an order
compelling Tercica to recall its false advertisements and issue
corrections, and an award of profits, damages, and attorney's fees
and costs. Insmed's counterclaim is part of its response to false
advertising claims that Tercica brought against Insmed in June.
Portions of those claims were dismissed by the Court earlier this
month. The matter is scheduled for trial in March. About IPLEX
IPLEX is approved in the United States as the only once daily
treatment for children with short stature associated with severe
primary IGF-I deficiency (Primary IGFD). IPLEX, a complex of
recombinant human IGF-I and its binding protein IGFBP-3
(rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF-I replacement
therapy that also replaces deficient IGFBP-3 in these patients. The
drug, which was launched in the second quarter of 2006, is also
being investigated for various other indications with unmet medical
needs, including severe insulin resistance, myotonic muscular
dystrophy and HIV Associated Adipose Redistribution Syndrome
(HARS). For more information about IPLEX please go to
www.go-IPLEX.com. About Insmed Insmed is a biopharmaceutical
company focused on the development and commercialization of drugs
for the treatment of metabolic diseases and endocrine disorders
with unmet medical needs. For more information, please visit
www.insmed.com. Forward Looking Statements Statements included
within this press release, which are not historical in nature, may
constitute forward-looking statements for the purposes of the safe
harbor provided by the Private Securities Litigation Reform Act of
1995. Forward-looking statements in this press release include, but
are not limited to, statements regarding the pending litigation and
or future ability to conduct our business as now conducted and as
it is currently proposed to be conducted. Such forward-looking
statements are subject to numerous risks and uncertainties,
including but not limited to the uncertainty of the outcome of any
litigation with Tercica, the risk that product candidates may fail
in the clinic or may not be successfully marketed or manufactured,
the company may lack financial resources to complete development of
product candidates or the FDA or other regulatory agencies may
interpret the results of our studies differently than we have. We
can give no assurances that we would be successful in any
litigation or that such litigation would not have a material
adverse effect on our business, financial condition and results of
operation. Furthermore, we may not be able to afford the expense of
defending against such a claim. As a result of these and other
risks and uncertainties, actual results may differ materially from
those described in this press release. For further information with
respect to factors that could cause actual results to differ from
expectations, reference is made to reports filed by the Company
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended.
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