Navigation Links
Insmed Initiates Clinical Study for Follow-on Biologic Version of Neulasta(R)
Date:10/14/2008

Company's INS-20 Receives Regulatory Clearance to Begin Phase I Clinical Trial

RICHMOND, Va., Oct. 14 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical study for the Company's second follow-on biologic (FOB) product candidate, INS-20. Insmed's INS-20 is a pegylated recombinant form of human G-CSF, and an FOB of the FDA-approved product Neulasta(R), which had U.S. sales of approximately $2.4 billion in 2007.

Pre-clinical studies demonstrated that INS-20 and FDA-approved Neulasta(R) are comparable in both their pharmacological and toxicological profile. Detailed analytical characterisation also demonstrated that the products have a high degree of similarity. Data from these initial evaluations have been used, in part, to support the Phase I study, which will be initiated immediately. The Phase I study will be conducted in the United Kingdom and will compare the safety and establish the bioequivalence of INS-20 to Neulasta(R). Results from the trial are anticipated in 2009, and are expected to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial.

"We continue to be pleased by the progress we are making in the development of our FOB portfolio, utilizing our unique protein drug development capabilities and technical expertise," said Dr. Geoffrey Allan, President and CEO of Insmed. "Each development milestone we achieve is further evidence of our strong position as a leader in this evolving industry. We intend to use the data to be generated from the Phase I trial, in combination with the positive pre-clinical results previously garnered, as the basis for discussions with the FDA in an effort to establish a Phase III development path for INS-20."

The initiation of t
'/>"/>

SOURCE Insmed Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Insmed CEO to Present at Congressional Briefing on Follow-On Biologics
2. Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
3. Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs
4. Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)
5. Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics
6. Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis
7. Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy
8. Circassia Initiates Further Phase II Clinical Study of Toleromune(R) Anti-Allergy Technology
9. Baxter Initiates Phase III Trial for the Treatment of Alzheimers Disease
10. S*BIO Initiates U.S. Phase I Clinical Trials of Oral JAK2 Inhibitor SB1518 for the Treatment of Hematological Malignancies
11. Enanta Initiates Phase 1 Study on EDP-322, an Oral Antibiotic With Activity Against Hospital- and Community-Acquired MRSA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... , July 11, 2014 Neurelis, Inc. ... ("Biotie") to end the option held by Biotie to ... further development of NRL-1 (intranasal diazepam) for pediatric and ... Over the past year, Biotie has advanced the ... preparation for the pivotal clinical work required for NDA ...
(Date:7/10/2014)... NEWS, Virginia , 11. Juli ... Hersteller von Kameras für die molekulare ... (MBI/BSGI), hat heute die CE-Zulassung für ... dem CE-Zeichen kann Dilon das Produkt ... Vertriebsbereich auf den Großteil der europäischen ...
(Date:7/10/2014)... 2014  Breg, Inc., a premier provider of ... FreeRunner™ knee brace with new innovations to help ... return to active lifestyles.  FreeRunner,s patent-pending design acts ... support when patients need it most, and the ... Patellofemoral issues are the most common cause ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2
... privately-held therapeutic device company, today announced that DEKRA and Health ... Matrix for clinical use and sale in Europe and Canada. ... resistant, and absorbable putty designed to rapidly stop bleeding when ... cut bone is a problem in many operative procedures including ...
... announces that a new market research report is available ... Deals Analysis 2011 http://www.reportlinker.com/p0180789/Medical-Equipment-Annual-Deals-Analysis-2011.html ... Summary GlobalData,s "Medical Equipment ... of data and trend analysis on mergers and acquisitions ...
Cached Medicine Technology:ORTHOCON® Receives CE Mark and Health Canada Medical Device License for HEMASORB® 2Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 2Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 3Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 4Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 5Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 6Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 7Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 8Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 9Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 10Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 11Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 12Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 13Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 14Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 15Reportlinker Adds Medical Equipment Annual Deals Analysis 2011 16
(Date:7/14/2014)... 14, 2014 EnergyFirst, manufacturer ... company Permalean for its great products, thriving ... Permalean, which markets its products as Jim’s Permalean Protein ... part of EnergyFirst’s lineup of nutritional products. The ... the coming year. , Founded in 1999, Permalean’s products ...
(Date:7/14/2014)... New research and analysis from the national ... examines toxic ingredients in tampons, a product used ... chemicals that may be found in the product’s absorptive ... put women’s health at risk. , According to ... , the potential impact of toxic chemical exposure from ...
(Date:7/13/2014)... FORT LEE, N.J. – Authors Leonard I. ... the science of tooth implants in their book ... describes recent advances and techniques in the world of dentistry ... who have lost all of their natural teeth. , Dr. ... subperiosteal implant in 1940. It was a mesh frame ...
(Date:7/13/2014)... 2014 MED-Ed Facilities is seeking proposals ... conference, April 7+8 in Boston at the Seaport Hotel. ... recent event. Presentations by individuals or teams are welcome. ... the types of sessions that were presented last year, ... proposal today! , Conference Director, The successful planning ...
(Date:7/13/2014)... Worldwide ladies are extremely responsive to Angeldress.co.uk’s pink ... approach and has created a lot of new items ... choices that responded directly to customers’ demands. , ... apparels. The company’s pink bridesmaid dresses come in many ... create the best products for customers from around the ...
Breaking Medicine News(10 mins):Health News:EnergyFirst Acquires Permalean - Manufacturer of All Natural Protein Bars and Powders 2Health News:EnergyFirst Acquires Permalean - Manufacturer of All Natural Protein Bars and Powders 3Health News:New Patent Analysis Shows Toxic Risk From Tampons 2Health News:New Patent Analysis Shows Toxic Risk From Tampons 3Health News:New Patent Analysis Shows Toxic Risk From Tampons 4Health News:New Patent Analysis Shows Toxic Risk From Tampons 5Health News:Authors Leonard I. Linkow and Sheldon Winkler Feature Advancements in Implant Dentistry 2Health News:Authors Leonard I. Linkow and Sheldon Winkler Feature Advancements in Implant Dentistry 3Health News:Authors Leonard I. Linkow and Sheldon Winkler Feature Advancements in Implant Dentistry 4Health News:MED-Ed Facilities Conference Call for Speakers Open 2Health News:Angeldress.co.uk Announces Summer Sale For Pink And Red Bridesmaid Dresses; The Current Discount Is Up To 80% Off 2
... you think. Low doses of radiation have been found to ... not uncommon for children who suffer from medulloblastoma to undergo ... in affecting IQ and reading skills of younger children rather ... has been found that the greatest rates of decline in ...
... has claimed at least 20 lives in the past two ... is already present in the neighboring Indian state of UP ... caused 10 deaths each in the townships of Tikapur and ... over 80 patients were undergoing treatment in various hospitals and ...
... that the loss of a gene called p63 accelerates the ... present in many organisms, including humans // . Drawing parallels ... is likely to play a fundamental biological role in aging-related ... researchers had devised a system for eliminating it from adult ...
... prevent infections in older people living at home, report ... segment of the supplement-taking population. //, ,Studies in ... supplements, elderly people in nursing homes were 20 per ... had fewer colds over the study period than a ...
... at Jefferson Medical College had discovered the existence of ... biomarker for conditions that lead to heart failures. Based ... a blood test to predict the onset of heart ... previously showed that an enzyme called GRK2 or beta-adrenergic ...
... become nearly twice as prevalent in high schools in the ... middle school students admit that drugs are used, kept or ... where drugs are widely available are three times more likely ... alcohol than their peers who attend drug-free schools., ,Availability ...
Cached Medicine News:Health News:Latest Research Shows That Multivitamins Might Not Prevent Infections In All Elderly 2Health News:Blood Test To Predict Heart Failures 2
... complete line of enteric disease ... and monoclonal/polyclonal antibody-based ELISA tests ... pathogens in fecal specimens. Our ... difficile, Entamoeba histolytica, Giardia, Cryptosporidium ...
... II test is also available with Inverness ... greatly reduces the hands-on time required to ... testing. The Fecal-Quik-Prep device is a unique ... amount of hands-on time required to prepare ...
... for autoimmune testing feature single-well ANA screen ... specific reflex tests including dsDNA, and 6 ... SS-B (La), Scl-70 and Jo-1. In addition, ... line of products for Cardiolipins (IgA, IgG, ...
... Our ELISA products for autoimmune testing ... ELISAs, as well as specific reflex tests ... Sm, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 ... family includes a full line of products ...
Medicine Products: