Insmed Inc. Releases Investor Fact Sheet with Updates on Drug Development Progress
25 Avril 2007 - 3:01PM
Business Wire
Insmed Inc. (NASDAQ:INSM), a biopharmaceutical company engaged in
the development and commercialization of drugs to treat patients
with unmet medical needs, today released an �Investor Fact Sheet�
detailing the progress of its drug development programs. The full
text of the Fact Sheet is as follows: Focusing on Markets with
Unmet Needs Insmed Incorporated (NASDAQ:INSM) is a
biopharmaceutical company engaged in the development and approval
of drugs to treat patients with metabolic diseases that currently
have limited or no treatment options. Our lead drug, IPLEX�, is a
complex composed of recombinant human insulin-like growth factor I
and insulin-like growth factor binding protein-3. Insmed is
presently moving forward on two very specific pathways. We are
continuing the development of IPLEX� for additional clinical
indications while concurrently studying the emerging generic
biologic market, recognizing the potential opportunities that exist
in this sector. Headquartered in Richmond, Virginia, Insmed
maintains a state-of the-art FDA-approved commercial biologic
manufacturing facility, Insmed Therapeutic Proteins, in Boulder,
Colorado. Background In 2005 IPLEX� was approved for the treatment
of growth failure in children with severe primary IGF-1 deficiency
(Primary IGFD) and was granted orphan drug status by the United
States Food and Drug Administration. In March 2007, Insmed settled
a patent litigation suit with Tercica, Inc. and Genentech, Inc.
Pursuant to the settlement, Insmed agreed to take IPLEX�, which had
been on the market for approximately six months, off the market for
Primary IGFD and discontinue development in all short stature
indications. In return, we retained the right to develop IPLEX� for
a wide range of non-short stature indications, with larger patient
populations and greater market potential. The IPLEX� Pipeline �
Targeted Research IPLEX� is currently being studied as a treatment
for several serious medical conditions, Myotonic Muscular Dystrophy
(MMD); Amyotrophic Lateral Sclerosis (ALS), also known as Lou
Gehrig�s Disease; HIV-Associated Adipose Redistribution Syndrome
(HARS); and retinopathy of prematurity (ROP). Cumulatively, these
disorders affect more than 100,000 patients in the United States,
and an equal number in the European Union, representing potential
markets that could be measured in the hundreds of millions of
dollars. Myotonic Muscular Dystrophy Research MMD is the most
common form of adult muscular dystrophy, affecting 1 in 8,000
individuals in the United States. Approximately 40,000 Americans
are diagnosed with the disease, and close to 60,000 people in the
European Union also suffer from this life-threatening disorder.
Patients with MMD develop progressive muscle wasting and weakness,
cardiovascular problems and digestive complications. In extreme
cases patients eventually become totally disabled and typically die
from respiratory or cardiac failure. At present there is no
treatment to halt or reverse the progression of MMD. IPLEX� is
being investigated in an ongoing open label Phase II clinical study
at the University of Rochester School of Medicine, with funding
provided by the Muscular Dystrophy Association and the National
Institutes of Health. The objective of the Phase II study is to
examine the safety, tolerability and initial efficacy of a
once-daily, subcutaneous injection of IPLEX� in patients with MMD.
We expect initial data from the first of these trials to be
available in the second quarter of 2007 and presented at a
scientific meeting in the third quarter of 2007. We currently plan
to initiate an expanded Phase II trial, with a larger number of
participants, by the end of 2007 and enter Phase III clinical
trials in early 2009. Italy Requests IPLEX� for ALS Patients In
January 2007, Insmed announced that the Italian Ministry of Health
had requested IPLEX� for Italian patients suffering from ALS. This
life-threatening neuromuscular disease strikes adults in mid-life.
In Italy approximately 1,000 new cases of ALS are diagnosed every
year. In cooperation with Cephalon, which holds the patent for
IGF-1in the European Union, Insmed is currently supplying IPLEX� on
a cost recovery basis to these Italian patients under an Expanded
Access Program. Data collected through the Expanded Access Program
in Italy will be used to design future ALS clinical development
studies with IPLEX�. IPLEX� for HARS IPLEX� is being explored as a
possible therapy for HARS. An estimated 80,000 HIV patients in the
United States have HARS, according to published reports. This
disorder is marked by abnormal metabolism including both central
fat accumulation (visceral adiposity and buffalo hump) with or
without fat loss in the limbs. These features have increased
markedly with the advent of highly active antiretroviral therapy
(HAART) for HIV. Recent studies performed in subjects on HAART
suggest nearly 50% of these individuals develop the morphologic
features characteristic of this syndrome. Preliminary data from a
Phase II open-label clinical study is currently being analyzed. The
study, directed by Morris Schambelan, M.D., a professor of medicine
at University of California San Francisco and Chief of
Endocrinology and Director of the General Clinical Research Center
at San Francisco General Hospital, is designed to evaluate the
safety and efficacy of 12 weeks of IPLEX� treatment in
subjects�with HARS. The primary objective of the study is to
determine the effects of IPLEX� on visceral�fat�distribution,
insulin sensitivity and glucose and lipid metabolism. We expect
initial data from this trial to be available in 2007, with
additional Phase II trials planned to begin in the first half of
2008 and Phase III trials planned to initiate in 2009. IPLEX� for
Retinopathy of Prematurity IPLEX� is currently in the first phase
of clinical development for the treatment of ROP. This disease,
which affects an estimated 14,000 to 16,000 premature infants each
year, impedes the development of the small blood vessels in the
back of the eye leading to blindness in the majority of cases. A
Phase I clinical study investigating IPLEX� as a treatment for ROP
has been initiated at the University of Gothenburg in Sweden, in
collaboration with scientists at the Harvard Medical School in the
United States. Ten patients are being enrolled sequentially, with
each subsequent patient receiving a higher dose of IPLEX�. The
objective of the study is to determine the dose of IPLEX� required
to increase serum IGF-1 levels into the normal physiological range.
Results of this study are currently expected by the end of 2007, at
which point a timeline for future clinical development will be
determined. Beyond IPLEX�: Oncology Compounds Insmed has two
oncology compounds, rhIGFBP-3 and INSM-18, in development. Both
hold promising potential treatments for a variety of cancers.
Preclinical models show that one or both treatments interact with
the IGF-1 system to reduce tumor growth in models of breast,
prostate, lung, colorectal and head and neck cancers. RhIGFBP-3 has
demonstrated preclinical efficacy in numerous cancer indications,
including breast, prostate, liver, ovarian and colon. Additionally,
several lines of recent evidence, from various cell systems, have
suggested that rhIGFBP-3 may play a more active, IGF-1-independent
role in growth regulation of cancer cells, binding specifically
with high affinity to the surface of various cell types and
directly inhibiting monolayer growth of these cells in an
IGF-1-independent manner. Also recent independent studies have
demonstrated that when IGFBP-3 is used in combination with other
cancer therapies it can accentuate and even synergize the efficacy
of standard cancer therapies. We have�an ongoing open label Phase I
clinical study with rhIGFBP-3 which is a dose-escalation study
designed to evaluate the safety, tolerability and pharmacokinetics
of a single intravenous dose of rhIGFBP-3. The primary goal of this
30-patient study is to identify the appropriate dose of rhIGFBP-3
for a planned Phase II clinical trial in breast cancer patients.
INSM-18 is an orally available, small molecule,�tyrosine
kinase�inhibitor. It has demonstrated dual inhibition�of the IGF-1
and HER2 receptors. Two single-dose Phase I clinical studies in
healthy volunteers have previously been completed with this drug
candidate. In both studies, the drug was safe and well-tolerated.
Additionally, a Phase I-II dose escalation clinical study designed
to define the maximum tolerated dose of INSM-18 in patients with
relapsed prostate cancer has been completed at the University of
California, San Francisco. This study consisted of a 28-day
treatment period at each dose level to investigate the effect of
INSM-18 on levels of prostate specific antigen (PSA). An analysis
of the data collected from the study is currently being conducted,
and the results will be used to design further Phase II clinical
studies. Manufacturing Edge Our state-of-the-art manufacturing
facility, Insmed Therapeutic Proteins (ITP), is FDA-inspected and
approved. Located in the biotechnology hub of Boulder, Colorado, we
believe ITP is a significant technological asset for Insmed. Given
its advanced protein manufacturing capability, combined with a
skilled work force, we believe we are well placed to leverage our
protein development and manufacturing expertise in a number of new
ventures, either through acquisitions or partnering. As pending
legislation is paving the way for affordable and safe alternatives
to existing biologics that will soon be coming off patent, we
believe our ITP facility and the inherent expertise developed at
the site positions Insmed for the potential development of generic
biologics Insmed Chairman and CEO Dr. Geoffrey Allan testified at
the United States House of Representatives Oversight and Government
Reform Committee with respect to generic biologics on March 16,
2007, stating, �Insmed has developed significant intellectual
capital focused towards protein characterization and purification.
We have invested in building the facilities required to manufacture
quality recombinant proteins. The combination of our proprietary
protein platform with a biogeneric protein platform meets our goal
to sustain innovation along with the ability to provide safe and
affordable drugs to address a growing economic issue.� Insmed has
an ongoing development program in the biogeneric area. We are
currently at an early stage in developing five protein products
which collectively could potentially represent several billion
dollars of sales in the United States market. We intend to seek a
partner to undertake the commercialization of these protein
products. Insmed Corporate Information Insmed Incorporated 8720
Stony Point Parkway Richmond, Virginia 23235 � Executive Management
Board of Directors � Geoffrey Allan, Ph.D. Chairman and Chief
Executive Officer Kenneth G. Condon Vice President for Financial
Affairs and Treasurer, Boston University � Ronald D. Gunn, M.S.,
M.B.A. Chief Operating Officer, EVP Graham K. Crooke, MB.BS.
Venture Capital Partner Asset Management Company � Kevin P. Tully,
CGA Chief Financial Officer, EVP Steinar J. Engelsen, M.D.
Director, Teknoinvest Management � Doug Farrar Vice-President,
Insmed Therapeutic Proteins Melvin Sharoky, M.D. President,
Somerset Pharmaceuticals � Randall W. Whitcomb, M.D. Founder and
Senior Clinical Research Fellow QuatRx Pharmaceuticals For more
information about Insmed, or to review our SEC filings, please
visit www.insmed.com About Insmed Incorporated Insmed is a
biopharmaceutical company focused on the development and
commercialization of drug candidates for the treatment of metabolic
diseases and endocrine disorders with unmet medical needs. For more
information, please visit www.insmed.com. Statements included
within this press release, which are not historical in nature, may
constitute forward-looking statements for 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 planned clinical trial
design, our regulatory and business strategies, plans and
objectives of management and growth opportunities for existing or
proposed products. Such forward-looking statements are subject to
numerous risks and uncertainties, including risks 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, the FDA may
interpret the results of our studies differently than we have,
competing products may be more successful, demand for new
pharmaceutical products may decrease, the biopharmaceutical
industry may experience negative market trends and other risks
detailed from time to time in the company's filings with the
Securities and Exchange Commission. 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. The forward-looking statements
made in this release are made only as of the date hereof and Insmed
disclaims any intention or responsibility for updating predictions
or financial guidance contained in this release.
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