Italian Ministry of Health Requests IPLEX(TM) for Treatment of ALS (Lou Gehrig's Disease)
10 Janvier 2007 - 3:00PM
Business Wire
Insmed Incorporated (NASDAQ: INSM) has been requested by the
Italian Ministry of Health, to make its drug, IPLEX�
(rhIGFI/rhIGFBP-3), available to physicians in Italy to treat
patients with Amyotrophic Lateral Sclerosis (ALS), also known as
Lou Gehrig�s Disease. The request comes as a result of several
Italian Court rulings ordering the Italian National Health System
to provide the drug to specific ALS patients who have petitioned
the Court. Through an agreement with Cephalon, which holds European
patent rights to IGF-1 pertaining to the treatment of ALS, Insmed
will be able to provide IPLEX to physicians in Italy. IPLEX will be
distributed through an expanded access program, with Insmed
receiving payment for drug from the Italian Health Authorities. ALS
is a neurodegenerative disorder that causes progressive muscle
weakness and loss of motor neurons. IGF-1 is a neurotrophic factor
essential for normal development of the nervous system. In animal
models and cell culture systems IGF-1 protects motor neurons and
promotes muscle and nerve regeneration. �We are very pleased that
the Italian ministry has approached us to help in treating this
devastating disease,� said Geoffrey Allan, President and CEO of
Insmed. �We greatly appreciate the fact that Cephalon has
collaborated with us in this effort. We hope that data collected
from this expanded access program will be useful for the further
clinical development of IPLEX for this indication,� he added. In
Italy, there are an estimated 1000 new cases of ALS per year. The
Ministry of Health has tried for several years to provide IGF-1 to
these patients and in doing so has contacted several pharmaceutical
companies worldwide. �We are very pleased that Insmed responded to
our request and are willing to provide IPLEX,� said Carlo Tomino of
the Italian Ministry of Health/AIFA. About ALS Amyotrophic lateral
sclerosis (ALS), often referred to as "Lou Gehrig's disease," is a
progressive neurodegenerative disease that affects nerve cells in
the brain and the spinal cord. Motor neurons reach from the brain
to the spinal cord and from the spinal cord to the muscles
throughout the body. The progressive degeneration of the motor
neurons in ALS eventually leads to their death. When the motor
neurons die, the ability of the brain to initiate and control
muscle movement is lost. With voluntary muscle action progressively
affected, patients in the later stages of the disease may become
totally paralyzed. Yet, through it all, for the vast majority of
people, their minds remain unaffected. While there is no cure or
treatment today that halts or reverses ALS, there are several drugs
in clinical trials that hold promise. The most recent study
involving IGF-1is being conducted by Dr. Eric Sorenson, of the Mayo
Medical Center, in Rochester, Minnesota. 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 (rhIGF-I/rhIGFBP-3), a complex of
recombinant human insulin-like growth factor-I (rhIGF-I) and its
predominant binding protein IGFBP-3 (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 visit 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 Company�s product plans. Such
forward-looking statements are subject to numerous risks and
uncertainties, including but not limited to the uncertainty of the
ultimate outcome of any litigation with Tercica and Genentech,
including litigation that resulted in a jury verdict finding that
Insmed infringed three patents owned by Genentech and exclusively
licensed by Tercica and awarding Genentech and Tercica past damages
of $7.5 million dollars as an upfront payment and a royalty of 15%
for past sales under $100 million and 20% for past sales over $100
million, 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 will be successful in overturning the jury
verdict either at the district court or on appeal or in avoiding an
injunction that Genentech and Tercica have requested to stop the
manufacture and sale of IPLEX or in avoiding the enhancement of
damages and award of attorney fees and costs that Genentech and
Tercica have also indicated they will seek 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, or paying
the damages awarded by the jury, as well as any enhanced damages or
attorney�s fees that may be awarded by the Court. We may also not
be able to continue to operate should an injunction issue. 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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