Navigation Links
Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)
Date:4/16/2008

INS-19 Receives Regulatory Clearance

RICHMOND, Va., April 16 /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 the Company's first clinical study for a follow-on biologic (FOB) product candidate. Insmed's INS-19, which is a recombinant form of human G-CSF, is a follow-on biologic of the FDA-approved product Neupogen(R), which had U.S. sales of approximately $0.9 billion in 2007.

Pre-clinical studies demonstrate that INS-19 and FDA-approved Neupogen(R) are comparable in both their pharmacological and toxicological profile. Detailed analytical characterisation also demonstrates 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 UK and will compare the safety and establish the bioequivalence of INS-19 to Neupogen(R). Results from the trial are expected in the second half of 2008, and are planned to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial in the U.S.

"By utilizing Insmed's unique protein drug development capabilities and technical expertise, the Company has been able to advance a follow-on biologic product candidate from project initiation to human testing in less than one year, a significant achievement," said Geoffrey Allan, CEO of Insmed. "We intend to utilize the data generated from the Phase I trial, in combination with the positive preclinical results previously garnered, as the basis for discussions with the FDA in an effort to establish a Phase III development path for INS-19."

The initiation of this follow-on biologic trial is the first of two planned for 2008 as part of Insme
'/>"/>

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

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics
2. Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis
3. Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy
4. Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infected Patients
5. Texas Heart(R) Institute at St. Lukes Episcopal Hospital Initiates First Clinical Trial in the World to Treat a Heart Attack Patient with a Special Stem Cell Type
6. Kosan Initiates Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer
7. Arena Pharmaceuticals Initiates Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia
8. Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
9. Repligen Initiates Phase 3 Clinical Trial of RG1068 for Pancreatic MRI Imaging
10. Metabolex Initiates Phase 1 Trial of MBX-2982
11. Phosphagenics Initiates its Phase 2 Clinical Trial in Type 1 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/19/2008)...9 Posit Science Corporation,resea...ty for Neuroscience,Annual Conference in Washingt...ng may benefit Baby Boomers. The computerized bra...es adaptive exercises that target auditory and,la...ve generalized,improvements in cognition by impro...
(Date:11/19/2008)... Isogen, a contract development an... today announced the first,phase launch of its co...,specifically address the process, facility and c...billion highly-niched, low-volume clinical and,ea...t. , Companies can invest over $100 million...
(Date:11/18/2008)...18 Forty-two leading U....ber national forum to consider cutting-edge innova...national economy from outbreaks of dangerous zoono... , Among those innovations: , , , ...en table that detects highly contagious and danger...
(Date:11/13/2008)...search Finds Statins Cut Risk of Heart Attacks, De.../ -- Cardiovascular Disease,is the leading cause o...stem hundreds of millions of dollars and causing u...ing this fatal disease - even among those who,were... that millions of people could cut their risk of a...
Breaking Medicine Technology:New Evidence That Brain-Plasticity Based Training has Broad Impact: Improved Cognition in Boomers, Improved Motor Control in Older Adults 2Isogen Launches Major New Facility to Address Global Biopharma Demand 242 Top U.S. Scientists and Specialists Explore Cutting-Edge Innovations to Defend America From Dangerous Zoonotic Diseases 2Seniors Can Be Heartened by New Study on Statins 2BioMarin Announces Program for ERT for Treatment of MPS IVA Morquio A Syndrome 5837 1BioMarin Announces Program for ERT for Treatment of MPS IVA Morquio A Syndrome 5837 2BioMarin Announces Program for ERT for Treatment of MPS IVA Morquio A Syndrome 5837 3BioMarin Announces Program for ERT for Treatment of MPS IVA Morquio A Syndrome 5837 4Ecological Society of America announces its 93rd Annual Meeting 3540 1Ecological Society of America announces its 93rd Annual Meeting 3540 2Ecological Society of America announces its 93rd Annual Meeting 3540 3A glass apart 21152 1Rush Copley Medical Center Selects Allscripts Electronic Health Record and Practice Management Solution 21148 1Rush Copley Medical Center Selects Allscripts Electronic Health Record and Practice Management Solution 21148 2Rush Copley Medical Center Selects Allscripts Electronic Health Record and Practice Management Solution 21148 3Rush Copley Medical Center Selects Allscripts Electronic Health Record and Practice Management Solution 21148 4
...tor The first human case of West Nile virus (WNV) ...n late June. The CDC has released few details on ...rst documented incidence of the mosquito borne dis...nded RNA flavivirus of about 11 kb. It primarily ... and other vertebrates serving as incidental hosts...
...cerides and cholesterols, vary with genetic predis...of these factors contribute to serum cholesterol a...isk of untoward vascular and cardiac events. Perha... values are so much in the public eye as serum lev...e discussion of plasma lipid test results an oppor...
Other Medicine Technology:West Nile Virus Screening and Diagnostics Technology Emerges In Step with North American Outbreak 2West Nile Virus Screening and Diagnostics Technology Emerges In Step with North American Outbreak 3West Nile Virus Screening and Diagnostics Technology Emerges In Step with North American Outbreak 4Analyzers Offer Point-of-Care Lipid Panels 2Analyzers Offer Point-of-Care Lipid Panels 3
(Date:11/21/2008)...ng may lead to new therapies for preterm labor , ...earchers say they,ve found the switch that activat...dbirth, a finding that may lead to therapies for p...ally binds the protein IP on the surface of these ...tive during pregnancy. , But researchers from ...
(Date:11/21/2008)...al meeting of shareholders to be held on January 8...stCall/ - Med-Emerg International Inc. ("MedEmerg"... of health services, announced today that it has o... Court of Justice concerning its previously announ...nt to which AIM Health Group Inc. ("AIM") will acq...
(Date:11/21/2008)...TON(Nov. 21, 2008)The University of Texas Health S..., Training Excellence in Aging Studies (TEXAS), to...h a prestigious $2 million award from the Donald W...g funds., "This will allow us to teach geriatric ...or medical student to practicing physicians. With ...
(Date:11/21/2008)...AND, Colo., Nov. 21 Hesk...t will present at the New York Society of,Securit...ma Conference on,December 2, 2008 at 1177 Avenue ...resentation is scheduled to begin at 9:35 a.m. Eas...vailable via live webcast and for two weeks,follo...
Breaking Medicine News(10 mins):Health News:Med-Emerg International Inc. obtains interim court order for plan of arrangement with AIM Health Group Inc. 2Health News:Med-Emerg International Inc. obtains interim court order for plan of arrangement with AIM Health Group Inc. 3Health News:UT Houston launches geriatric training with $3.25 million in grant, matching funds 2Health News:UT Houston launches geriatric training with $3.25 million in grant, matching funds 3Health News:UT Houston launches geriatric training with $3.25 million in grant, matching funds 4
...gular heart beats and have a tendency to form bloo...arts. These clots can then travel to the brain, bl...ng the risk of this occurring is to give drugs tha...ots. Two commonly used options are anticoagulants ...
...e chance of successfully quitting can be enhanced ... during their stay, and then have at least one mon... people, going in to hospital provides an opportun...als are now smoke-free, any smoker has to stop tem...
...a huge pink hot air balloon - is set Friday to fly...ness . The balloon - which organisers hope will en...d by seven local branches of the public medical se...al in Lichtenvoorde, a small town near Almelo in t...
...registration in certain parts of India is not sati...ar, 10 million still go unregistered . Two out of ...re do not exist for government planning purposes, ...rnmental organisation (NGO) said. The registratio...
Other Medicine News:Health News:Anticoagulants is Better for Atrial Fibrillation 2Health News:Hospital Provides an Oppurtunity to Quit Smoking 2Health News:Millions of Births Still Go Unreported in India 2
Medical Claims Billing
Managed care is a billing and tracking system.
Visionary OFFICE™ PM offers a Windows interface featuring medical billing, appointment scheduling and patient information.
HCS INTERACTANT is an integrated healthcare information system. Financial applications include general ledger, accounts payable, human resources and comprehensive management reporting. HCS general fi
Medicine Products: