Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)
30 Mars 2009 - 11:30PM
PR Newswire (US)
INSMED WILL CONTINUE TO MANAGE ALS EAP IN ITALY AND ALL IPLEX(TM)
INITIATIVES IN THE U.S. RICHMOND, Va., March 30
/PRNewswire-FirstCall/ -- Insmed Inc. (NASDAQ: INSM), a
biopharmaceutical company, today announced the signing of an
agreement with IDIS, a private, UK-based company specializing in
the management of medicines on a named patient basis, also known as
expanded access programs (EAPs) or named patient programs (NPPs),
to manage such programs for the investigational drug IPLEX(TM)
worldwide, excluding the U.S. and Italy. An EAP or NPP provides
drug developers across the world with a legal and ethical way to
make medicines available, where appropriate, in response to
requests made by physicians, when those medicines are not yet
approved in their country. Under the agreement, Insmed will
continue to be responsible for the IPLEX(TM) EAP for Amyotrophic
Lateral Sclerosis (ALS) in Italy, as well as all IPLEX(TM)-related
activities in the U.S., while IDIS will assume responsibility for
the management of IPLEX(TM) for all other EAPs/NPPs worldwide. IDIS
is expected to initiate the management of these EAPs/NPPs during
the second quarter of 2009, and will be responsible for
prescription, product and pharmacovigilance management. "This
agreement reflects Insmed's deep commitment to providing IPLEX(TM)
to patients that are suffering from debilitating diseases, such as
Amyotrophic Lateral Sclerosis, and have no other medical options,"
said Dr. Geoffrey Allan, President and CEO of Insmed. "IDIS is a
world leader in the management of named patient programs, has
significant knowledge of the various unique healthcare systems
internationally and is the ideal partner to ensure that patients
have appropriate access to IPLEX(TM)." "We are pleased to be
working with Insmed in order to expand access to IPLEX(TM), a drug
that has shown significant potential in multiple important
therapeutic categories," said John Lagus, Vice President of
Business Development for IDIS. About IPLEX(TM) IPLEX(TM) was
approved in the United States in December 2005 for the treatment of
children with growth failure due to severe primary IGF-I deficiency
(Primary IGFD). IPLEX(TM) rhIGF-I/rhIGFBP-3), is a complex of
recombinant human insulin-like growth factor-I (rhIGF-I) and its
predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also
being investigated for various other indications with unmet medical
needs. About Insmed Insmed Inc. is a biopharmaceutical company with
unique protein development experience and a proprietary protein
platform aimed at niche markets with unmet medical needs. For more
information, please visit http://www.insmed.com/. About IDIS IDIS
is the world leader in the development and implementation of Named
Patient Programs and has a proven track record of working in
strategic partnership with U.S.-based companies to bring new
medicines to Europe for the first time. IDIS supports its customers
in over 100 countries worldwide, supplying more than 400 different
medicines per month and responding to more than half a million
requests on a named-patient basis to medical professionals
worldwide. Headquartered near central London, IDIS has been a
strategic partner to more than 40 pharmaceutical and biotech
companies. For more information on IDIS, please visit the website
http://www.idispharma.com/ or contact John Lagus at .
Forward-Looking Statements This release contains forward-looking
statements which are made pursuant to provisions of Section 21E of
the Securities Exchange Act of 1934. Investors are cautioned that
such statements in this release, including statements relating to
planned clinical study design, regulatory and business strategies,
plans and objectives of management and growth opportunities for
existing or proposed products, constitute forward-looking
statements which involve risks and uncertainties that could cause
actual results to differ materially from those anticipated by the
forward-looking statements. The risks and uncertainties include,
without limitation, risks that closing conditions under our
agreement with Merck & Co., Inc. may not be met, product
candidates may fail in the clinic or may not be successfully
marketed or manufactured, we may lack financial resources to
complete development of product candidates, the FDA may interpret
the results of studies differently than us, competing products may
be more successful, demand for new pharmaceutical products may
decrease, the biopharmaceutical industry may experience negative
market trends, our continuing efforts to develop IPLEX(TM) may be
unsuccessful our common stock could be delisted from the Nasdaq
Capital Market and other risks and challenges detailed in our
filings with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K for the year ended December 31,
2007. Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this
release. We undertake no obligation to publicly release the results
of any revisions to these forward-looking statements that may be
made to reflect events or circumstances that occur after the date
of this release or to reflect the occurrence of unanticipated
events. Investor Relations Contact: Brian Ritchie - FD 212-850-5683
Media Contact: Irma Gomez-Dib - FD 212-850-5761 DATASOURCE: Insmed
Incorporated CONTACT: Investor Relations Contact: Brian Ritchie,
FD, +1-212-850-5683, ; or Media Contact: Irma Gomez-Dib, FD,
+1-212-850-5761, Web Site: http://www.insmed.com/
http://www.idispharma.com/
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