Navigation Links
Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)
Date:3/30/2009

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
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Insmed Announces That NASDAQ Further Extends Temporary Suspension of Minimum Bid Closing Price Rule
2. Insmed Announces Fourth Quarter and Full-Year 2008 Financial Results
3. Insmed to Host Fourth Quarter and Full-Year 2008 Conference Call
4. Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
5. Insmed to Present at Sanford C. Bernstein Biosimilars Long View Conference
6. Insmed Announces Financial Results for Third Quarter and Nine-Months Ended September 30, 2008
7. NASDAQs Temporary Suspension of Minimum Bid Closing Price Rules Extends Insmeds Compliance Date to March 20, 2009
8. Insmed Announces That NASDAQ Temporarily Suspends Minimum Bid Closing Price Rule
9. Insmed to Seek Shareholder Approval for Reverse Split
10. Insmed and Premacure Cite Study Results Demonstrating Potential Effectiveness of IPLEX(TM) in Preventing Blindness in Premature Infants
11. Insmed to Present at Biosimilars 2008 Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... ... 18, 2017 , ... LabRoots , the leading provider ... world, was today awarded the "Best Science & Technology Social Networking Service 2016" ... decided upon by a dedicated team of researchers and analysts. , The 2016 ...
(Date:1/19/2017)... 18, 2017  Northwest Biotherapeutics, Inc. (OTCQB: NWBO) ("NW ... therapies for operable and inoperable solid tumor cancers, announced ... Officer of NW Bio, will present at the Phacilitate ... the Hyatt Regency Hotel in Miami, Florida ... session entitled "New Therapeutic Approaches – Expanding the Reach ...
(Date:1/18/2017)... According to a new market research report "In situ ... & End User (Molecular Diagnostic Laboratories, Academic and Research Institutions) - Global Forecast ... Million by 2021 from USD 557.1 Million in 2016, growing at a CAGR ... ... MarketsandMarkets Logo ...
(Date:1/18/2017)... ... January 18, 2017 , ... Executive search ... in its continued commitment to the advancement of the clinical trials segment. Hosted ... related to clinical trial planning and management. , As executive talent specialists ...
Breaking Biology Technology:
(Date:12/15/2016)... AUBURN HILLS, Mich. , Dec. 15, 2016 /PRNewswire/ ... simply unlocking car doors or starting the engine. Continental ... 2017 in Las Vegas . Through ... PASE (Passive Start and Entry) and biometric elements, the ... the field of vehicle personalization and authentication. ...
(Date:12/8/2016)... -- Singulex, Inc., the leader in Next Generation Immunodiagnostics powered ... and supply agreement with Thermo Fisher Scientific, the world ... to Thermo Scientific BRAHMS PCT (Procalcitonin), a biomarker which, ... diagnose systemic bacterial infection and sepsis and in ... assessing the risk of critically ill patients for progression ...
(Date:12/7/2016)... , Dec. 7, 2016   Veridium , ... the appointment of new CEO James Stickland ... with decades of experience, has served in senior ... where he specialized in expanding a pipeline of ... portfolios. He most recently served as managing director ...
Breaking Biology News(10 mins):