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© ALS Independence 2003-08
RICHMOND, Va.,
Nov. 10 /PRNewswire-FirstCall/
Insmed Inc. (Nasdaq:INSM), a developer of follow-on
biologics and biopharmaceuticals, today announced that Genentech, Ipsen/Tercica
and Insmed jointly issued the following statement:
Genentech, Ipsen/Tercica, and Insmed have been contacted by people living with
Amyotrophic Lateral Sclerosis (ALS) and their loved ones seeking access to an
IGF-I/IGFBP3 product called IPLEX(TM), which is solely manufactured by Insmed.
We understand the devastation a disease like ALS causes and that there are a
lack of available therapies that provide meaningful clinical benefit.
Although IPLEX(TM) has not been rigorously tested in people with ALS, nor
received regulatory approval for use in ALS, all the companies involved
appreciate the urgency and desperation for new treatments in the ALS community.
We are all working diligently to determine how best to respond
to that need.
The availability of IPLEX(TM) is subject to a Court-Ordered Settlement
Agreement. On November 8, 2008, Genentech and Ipsen/Tercica signed a letter of
intent whereby they have consented to amend the Court-Ordered Settlement
Agreement to permit Insmed to supply IPLEX(TM) in connection with named-patient
ALS programs worldwide on a royalty-free basis. Insmed's ability to do so will
be dependent on satisfying any regulatory requirements in any country where a
request for treatment is made.
Ipsen/Tercica and Insmed also plan to enter into negotiations concerning the
development of IPLEX(TM) for the treatment of ALS, subject to analyzing the data
from the ALS patients in Italy who have received IPLEX(TM), and satisfying any
applicable regulatory requirements.
These actions represent each company's commitment to find a solution to the
requests coming from the community of patients and their families. Insmed will
update the community as further progress is made.
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 ALS in Italy and in Myotonic
Muscular Dystrophy.
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, 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, we may be unable to
secure
an appropriate business partner for our follow-on biologics business, 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.
"When there is no peril in the fight there is no glory in the triumph." Pierre Corneielle
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© ALS Independence 2003-08