NORD Honors Insmed for Role in Developing Treatments for Rare Diseases
25 Avril 2006 - 4:30PM
PR Newswire (US)
Company Saluted for Research in Treating Children With Extreme
Short Stature RICHMOND, Va., April 25 /PRNewswire-FirstCall/ --
Insmed Incorporated (NASDAQ:INSM) was honored by the National
Organization for Rare Disorders (NORD) last night at its annual
Tribute Banquet for the development of IPLEX(TM) (mecasermin
rinfabate (rDNA origin) injection) for the treatment of growth
failure in children with severe primary IGF-1 deficiency (Primary
IGFD) or with growth hormone (GH) gene deletion who have developed
neutralizing antibodies to GH. IPLEX was approved by the United
States Food and Drug Administration in December 2005 as an orphan
drug. "For many years we've recognized the need for treatment for
Primary IGF-1 deficiency, but few companies were willing to
commercially develop insulin- like growth factor until now.
IPLEX(TM) is a significant medical advancement worthy of
recognition and we thank Insmed for this important contribution,"
said Abbey S. Meyers, President of NORD. "We applaud NORD's
longstanding tradition of recognizing those that dedicate their
life's work to finding treatments for rare diseases, and we are
delighted to be included in this celebration," said Ronald D. Gunn,
M.B.A., Executive Vice President and Chief Operating Officer of
Insmed. "IPLEX(TM) is the culmination of over 20 years of dedicated
research and development, and represents a breakthrough in IGF-1
replacement therapy, with potential benefits in several additional
rare diseases with unmet medical needs." About IPLEX IPLEX, a
complex of rhIGF-1 and rhIGFBP-3, is the only once-daily IGF-1
replacement therapy and the only therapy that provides both IGF-1
and IGFBP-3 that is approved by the FDA to treat children with
severe Primary IGFD. The drug, expected to launch during the second
quarter of calendar year 2006, is also being studied for various
other indications with unmet medical needs including extreme
insulin resistance, myotonic muscular dystrophy and HIV Associated
Adipose Redistribution Syndrome (HARS). About the Condition Severe
Primary IGFD is a genetic condition in which patients do not
generate sufficient quantities of insulin-like growth factor-I
(IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3),
two key proteins involved in mediating the effects of growth
hormone. Patients with severe Primary IGFD present with extreme
short stature (height standard deviation score, SDS < -3) and an
extremely poor prognosis for adult stature. Whereas prepubertal
height SDS can range as low as -9, a blunted pubertal growth spurt
is usually apparent, resulting in adult height that is typically
5-12 SD's below the normal population (adult height between 100 and
140 cm). The profound short stature in patients is often associated
with severe psychosocial problems. About Insmed Incorporated Insmed
is a biopharmaceutical company focused on the discovery and
development of drug candidates for the treatment of metabolic
diseases and endocrine disorders with unmet medical needs. For more
information, please visit http://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.
DATASOURCE: Insmed Incorporated CONTACT: Natalie Wyeth,
+1-202-835-9473, or , for Insmed Incorporated Web site:
http://www.insmed.com/
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