Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)

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Mon Mar 30, 2009 5:30pm EDT

Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for
IPLEX(TM)

 


 
INSMED WILL CONTINUE TO MANAGE ALS EAP IN ITALY AND ALL IPLEX(TM) INITIATIVES
IN THE U.S.

IDIS WILL HAVE RESPONSIBILITY FOR REST OF WORLD


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 www.idispharma.com or contact
John Lagus at NPP@idispharma.com.

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
    brian.ritchie@fd.com

    Media Contact:
    Irma Gomez-Dib - FD
    212-850-5761
    irma.gomez-dib@fd.com



SOURCE  Insmed Incorporated

Investor Relations Contact:  Brian Ritchie, FD, +1-212-850-5683,
brian.ritchie@fd.com; or Media Contact: Irma Gomez-Dib, FD, +1-212-850-5761,
irma.gomez-dib@fd.com
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