Insmed Receives Approvable Letter for iPlex(TM); Conference Call Tomorrow at 8:00am EST
28 Septembre 2005 - 12:55AM
Business Wire
Insmed Incorporated (NASDAQ-NMS: INSM) (NASDAQ: INSM) announced
today the receipt of an Approvable Letter from United States Food
and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3)
(Mecasermin rinfibate), for the treatment of children with growth
failure who suffer from Severe Primary IGF-1 deficiency (Primary
IGFD). Previously Insmed referred to its primary indication as
Growth Hormone Insensitivity Syndrome (GHIS). Based on FDA input
GHIS is now referred to as Severe Primary IGFD. iPlex is the new
worldwide trade name for Insmed's proprietary combination of
rhIGF-I/rhIGFBP-3 which was previously called SomatoKine. The
Approvable Letter Insmed received is an official notification that
the FDA has completed the review of the iPlex New Drug Application
(NDA) and has found the application to be sufficiently complete for
full approval pending the submission of additional information
primarily regarding the Chemistry, Manufacturing and Controls (CMC)
section of the application. FDA is not requiring the Company to
conduct additional preclinical or clinical trials. FDA has informed
Insmed that they are still considering iPlex's orphan exclusivity
status. "The Company plans to rapidly respond to these questions
and work with the Agency to resolve all outstanding issues. I look
forward to the completion of our work with the FDA so that we may
bring this product to the clinic, and provide caregivers with this
important therapeutic option for their patients", added Geoffrey
Allan, Ph.D., President and Chief Executive Officer of Insmed.
"Based on my experience with therapies for a variety of growth
disorders, it is clear that the pediatric endocrine community will
welcome this alternative therapy. Throughout the clinical
development program, iPlex therapy has demonstrated a very
favorable safety profile, in addition to the robust growth
response," commented Kenneth Attie, M.D. Chief Medical Officer for
Insmed. Conference Call at 8:00am Insmed management will host a
conference call at 8:00am ET, September 28, 2005. To participate in
the conference call, dial 800-811-8824 (domestic) or 913-981-4903
(international). The call will be webcast live through Insmed's
corporate website: www.insmed.com. A telephonic replay of the call
will be available for one week at 888-203-1112 (domestic) or
719-457-0820 (international) Passcode: 2242133 A web replay of the
call will be available through the corporate website beginning at
10:00 a.m. 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
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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