Insmed Provides Update on IPLEX(TM) Launch; Company Shares Details on Payer Usage Program and Pricing
09 Juin 2006 - 2:04PM
Business Wire
Insmed, Inc (NASDAQ: INSM) today provided an update on the launch
of IPLEX (mecasermin rinfabate (rDNA origin) injection) and the
Company's payer Utilization Program for the treatment of patients
with severe short stature associated with severe primary IGF-I
deficiency (Primary IGFD). On May 23, 2006, Insmed announced the
IPLEX Utilization Program to approximately 800 national payers as
part of its comprehensive launch communications. In a letter to
payers, Insmed informed them of the availability and pricing of
IPLEX. Prominent in the announcement was a statement specifically
detailing Insmed's pricing commitment to this market. Insmed
proactively created the utilization program, and informed the payer
universe that the annual charge for therapy is limited to actual
milligrams prescribed and used. The utilization program assures
that there is no charge for unused product remaining after the
prescribed dose is extracted. Any remaining product discarded as
waste is accounted for, and replaced by the company at no charge to
the payer or patient, to assure that the payer or patient pays only
for the amount dosed and administered. The utilization program, and
other distribution activities, is managed by Insmed's single point
of contact system, PlexPoint(TM). "Insmed is committed to the
Primary IGFD market place. Everything we've done during launch was
designed to increase patient access to this important once-a-day
therapy," remarked Philip J. Young, Chief Business Officer. "We
made the decision to bring IPLEX to the market as rapidly as
possible after receiving FDA approval and Orphan Designation in
December 2005. As part of our launch we proactively announced the
IPLEX Utilization Program, the first of its kind in the industry,
guaranteeing payers and patients they would only pay for IPLEX that
is prescribed and used." Insmed is aware that price comparisons
between the available IGF-I replacement therapies have been
attempted. However, the company believes that it would be
inappropriate to draw conclusions from unbalanced pricing
comparisons as the assumptions are not based in fact, nor
reinforced by market practices and physician prescribing trends.
The therapeutic dose range for IPLEX is 1 mg/kg to 2 mg/kg taken
once daily. A comparison using only the 2 mg/kg dose is
inappropriate in light of the fact that the patients with the best
growth response in the pivotal study, (efficacy which was similar
to published studies with rhIGF-I), received approximately 1.4
mg/kg, once daily. "We believe we have a competitively priced
product with an excellent safety and efficacy profile. We are
pleased with how well the market is responding to IPLEX at this
early stage and believe that the attributes of IPLEX will continue
to prove attractive to prescribing physicians, payers and
patients," Young added. Insmed is committed to this utilization
program until the release of a shelf stable, multi-dose vial and
delivery system, which is planned to be available in 2007. We
believe our manufacturing facility in Boulder, Colorado provides us
with the capability to manage the cost of IPLEX within a reasonable
range while we continue the development of a new product
formulation. The Insmed Sales and Managed Care teams are working to
ensure that the target audiences are aware of the Utilization
Program and the attributes of IPLEX therapy. Pricing for IPLEX, the
only FDA approved once-daily IGF-I replacement therapy, is
available on all of the standard pharmaceutical databases. Further
information about IPLEX is available at www.go-IPLEX.com or by
calling 1-866-go-IPLEX (1-866-464-7539). 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. The
Company's leading product, IPLEX was approved as an orphan drug by
the United States Food and Drug Administration in December 2005 for
the treatment of growth failure in children with severe primary
IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene
deletion who have developed neutralizing antibodies to GH. About
IPLEX IPLEX, a complex of recombinant human IGF-I and its binding
protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I
replacement therapy. It is also the only FDA-approved therapy that
provides both IGF-I and IGFBP-3 to treat children with severe
primary IGFD. The drug which was launched in the second quarter of
2006, is also being investigated 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 or acquired condition in which patients do not generate
sufficient quantities of insulin-like growth factor-I (IGF-I) due
to a defect in the growth hormone (GH) receptor/IGF-I pathway. Gene
mutations leading to growth failure due to IGF-I deficiency have
been identified in the growth hormone receptor, in the GH receptor
signalling pathway, and in the IGF-I gene itself. Patients with
severe primary IGFD present with marked short stature and a poor
prognosis for adult stature. 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 our IPLEX utilization program,
regulatory and business strategies, manufacturing capabilities,
product costs, 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 launched, marketed,
manufactured or reimbursed, we 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 our 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 our 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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