Navigation Links
Insmed Provides Update on Supply of IPLEX(TM)
Date:7/27/2009

RICHMOND, Va., July 27 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today announced that, effective immediately, the Company will cease the supply of IPLEX((TM)) to any new patients. In addition, the Company will not initiate further clinical trials with IPLEX((TM)) at this time. The Company has determined that its limited inventory on hand must be conserved for the treatment of existing patients.

Following the previously announced sale of Insmed's Boulder, Colorado manufacturing facility to Merck & Co., Inc. in March 2009, Insmed no longer has the capability to manufacture IPLEX((TM)), an extremely complicated drug to produce. Moreover, any agreement with a third party to undertake the manufacture of IPLEX((TM)), if it was economically feasible and could be arranged, would not result in production of additional quantities of IPLEX(TM) for at least 12 to 18 months.

There are approximately 70 patients who currently receive IPLEX(TM), 12 in the U.S. and the remainder around the rest of the world. Most of the patients receive IPLEX(TM) pursuant to a court-ordered Extended Access Program (EAP) for Amyotrophic Lateral Sclerosis (ALS) in Italy. The 12 U.S. patients are being treated for ALS under single patient Investigational New Drug applications approved by the U.S. Food and Drug Administration. The Company believes that it has sufficient IPLEX(TM) inventory to supply these patients for no more than 24 months.

The Company intends to analyze the on-going data collected for various indications, including myotonic muscular dystrophy and ALS, and assess the overall IPLEX(TM) development program, including possible IPLEX(TM) manufacturing options with third parties and possible future clinical trials. Initiation of the Phase II clinical trial for ALS patients in the U.S. that had been discussed with FDA earlier this year has been postponed while the Company performs this assessment.

Dr. Melvin Sharoky, Insmed's Chairman, said, "We believe that it is in the best interests of patients who are currently receiving IPLEX(TM) to ensure that our current limited inventory is conserved in order to maintain their drug supply as long as possible, while allowing the Company time to consider its development options."

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.

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 the existing supply of IPLEX(TM) and possible production of additional quantities of IPLEX(TM) by third party manufacturers, 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, the available supply of IPLEX(TM) may be used more quickly than expected; we may decide not to pursue a third party manufacturing arrangement for IPLEX(TM); if we decide to pursue such a manufacturing arrangement, we may not be able to find a third party manufacturer willing to produce IPLEX(TM) or be able to negotiate acceptable terms; it may take any third party manufacturer more time than expected to successfully begin producing new supplies of IPLEX(TM) 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, 2008. 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 Relations Contact:
    Irma Gomez-Dib - FD
    212-850-5761
    irma.gomez-dib@fd.com


'/>"/>
SOURCE Insmed Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Insmed Completes Sale of Follow-On Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
2. Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Under an IND
3. Insmed and Premacure Announce European Orphan Designation for IPLEX(TM) in Retinopathy of Prematurity in Infants
4. Insmed Gains Royalty-Free Worldwide Rights for IPLEX(TM) in Connection with Potential Expanded Access ALS Programs
5. Insmed to Present at Upcoming Healthcare Conferences
6. Insmed to Present at the IBC 5th Annual Global Follow-On Biologics Conference
7. President Obamas Visit to Cleveland Clinic Provides Look at High-Quality, Cost-Effective Healthcare Delivery Model
8. Study provides documentation that tumor stem-like cells exist in benign tumors
9. Align Technology Provides Update on Patent Litigation with Ormco Corporation
10. International Isotopes Inc. Announces Results of the Annual Meeting and Provides an Update on its Depleted Uranium Processing and Fluorine Extraction Process Plant
11. Leading Los Angeles Clinic (laserandveinclinic.com) Provides Top Notch Aesthetic Laser Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/6/2016)... IL (PRWEB) , ... February 06, 2016 , ... ... recovery phases of eating disorder treatment helps to reduce the frequency and level ... of the Recovery Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV ... the much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream ... Each week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco Canales, ... services in their Napa Valley office. The technique utilizes the body’s own healing ... Canales and Dr. Furnas, are part of only a select few cosmetic surgeons ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... ... organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community ... is poised to once again host, Swirl, A Wine Tasting Event at the ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know the routine: each ... longer to access the treadmills. It’s a predictable trend. After the excesses of November ... get in shape by joining gyms, starting new walking or running routines, or signing ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... Feb. 5, 2016  ivWatch, a medical devices company, is ... Award granted by Governor Terry McAuliffe,s office. ivWatch ... February 25th at an event to be held at the ... award honors professionals and business that have made significant contributions ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... , Feb. 5, 2016 Aethlon Medical, Inc. ... , Chairman and CEO, will be presenting at Source Capital ... New York, NY at 2:15 p.m. ET on ... an Immunotherapy Panel discussion taking place at 3:15 p.m. ET. ... replay approximately one hour after the conclusion of the live ...
(Date:2/5/2016)... India , February 5, 2016 ... a new market research report "Fetal (Labor & Delivery) ... & Antepartum), Warmer, Incubator, Pulse Oximeter, Phototherapy/Jaundice Management Devices, ... published by MarketsandMarkets, This report studies the global market ... market is estimated at USD 6.28 Billion in 2015 ...
Breaking Medicine Technology: