European Medicines Agency Validates Insmed's Regulatory Application For Marketing IPLEX(TM) in Europe
05 Juillet 2006 - 3:15PM
PR Newswire (US)
IPLEX(TM) Also Receives European Orphan Drug Designations RICHMOND,
Va., July 5 /PRNewswire-FirstCall/ -- Insmed Incorporated
(NASDAQ:INSM): Insmed today announced the European Medicines Agency
(EMEA) has validated its application to market IPLEX(TM)
(mecasermin rinfabate (rDNA origin) injection), in the European
Union (EU). The validation was granted within the scope of the EU
Commission designations of IPLEX as an orphan medicinal product for
the Treatment of primary insulin-like growth factor-1 deficiency
due to molecular or genetic defects (EU/3/06/378); and Treatment of
patients with growth hormone (GH) gene deletion who have developed
neutralizing antibodies to GH (EU/3/06/377). "We are pleased to
have reached this important milestone in the European drug approval
process and particularly at this time as it positions us ahead of
schedule in our pursuit of EU approval," said Geoffrey Allan,
President and Chief Executive Officer of Insmed. "This is just one
more example of Insmed's ability and commitment to execute our
development and commercialization plans." The validation signifies
that the EMEA can now begin review of Insmed's marketing
authorization application. The review process is being coordinated
by the EMEA under the centralized licensing procedure, which, if
resulting in approval, provides one marketing authorization for all
25 member states of the EU, as well as Norway and Iceland. With the
validation step complete, the application will be assessed on a
timetable that could lead to an approval and marketing
authorization in 2007. The orphan medicinal product status would
assure Insmed Inc. a ten year period to market IPLEX in the EU.
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
http://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 http://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. DATASOURCE: Insmed Incorporated
CONTACT: Media - Natalie Wyeth, Ketchum Public Relations,
+1-202-835-9373, ; Investors - Tim Ryan, The Trout Group,
+1-212-477-9007 x24, , both for Insmed Incorporated Web site:
http://www.insmed.com/ http://www.go-iplex.com/
Copyright
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024