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RICHMOND, Va., March 30, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- 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
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.
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.
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.
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.
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.