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:11/20/2009)... 20 The Department of H... members of priority groups that did not have prev...inics are being held statewide on Nov. 20-22. Frid...on Saturday, Nov. 21, will be 8 a.m. to 2 p.m. On ....m. to 8 p.m. ,, Individuals in the recommende...
(Date:11/20/2009)... ,, Reportlinker.com announces t...ts catalogue. ,, Global Markets for Breast Bio...com/p0164741/Global-Markets-for-Breast-Biopsy-Devi...=pr&utm_campaign=prnewswire ,, The global...ring loaded core needle market and vacuum assisted...
(Date:11/20/2009)...Newswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: ...nd Chief Executive Officer, and Greg Browne, Chief...l Piper Jaffray Health Care Conference in New York...The conference session and webcast will be audio o... Jaffray will host a webcast of the presentation l...
Breaking Medicine Technology:Pennsylvania Department of Health Begins Statewide H1N1 Vaccination Clinics Targeting Priority Populations; Some Appointments Still Available 2Reportlinker Adds Global Markets for Breast Biopsy Devices 2009 2Cyberonics to Present at 21st Annual Piper Jaffray Health Care Conference 2Oral Drug Ups Survival in Advanced Prostate Cancer Cases 54170 1Oral Drug Ups Survival in Advanced Prostate Cancer Cases 54170 2National Breast Cancer Foundation Inc to Partner with XtremeSportsID 26amp 3B 238482 3B on Revolutionary Medical Identification Bracelet 54166 1National Breast Cancer Foundation Inc to Partner with XtremeSportsID 26amp 3B 238482 3B on Revolutionary Medical Identification Bracelet 54166 2National Breast Cancer Foundation Inc to Partner with XtremeSportsID 26amp 3B 238482 3B on Revolutionary Medical Identification Bracelet 54166 3Video 3A People With Pain Healthcare Providers Sound Off in First Ever Online Talk Show About Pain 54162 1Video 3A People With Pain Healthcare Providers Sound Off in First Ever Online Talk Show About Pain 54162 2Video 3A People With Pain Healthcare Providers Sound Off in First Ever Online Talk Show About Pain 54162 3Video 3A People With Pain Healthcare Providers Sound Off in First Ever Online Talk Show About Pain 54162 4Video 3A People With Pain Healthcare Providers Sound Off in First Ever Online Talk Show About Pain 54162 5
... generally consistent with oral olanzapine ...s, VENICE, Italy, June 23 Results from,olanzapin...ed that the,efficacy and safety profile of olanzap...exa(R) (olanzapine) with the exception of injectio...ce study (HGKA) and interim,findings from an ongoi...
...axoSmithKline,(NYSE: GSK ) today announced that t...extended the priority review period for PROMACTA(R...eviously treated patients,with chronic idiopathic ...e,to review the application. The Prescription Drug...er 19, 2008., On May 30, the Oncology Drugs Advis...
Other Medicine Technology:Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 2Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 3Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 4Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 5Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 6Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 7Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference 8GSK Update on FDA Review of Promacta(R) (Eltrombopag) 2
(Date:11/20/2009)...J, Nov. 20 /PRNewswire-FirstCall/ - NUCRYST Pharma...ting of Shareholders will be held on Monday, Decem...sider approval of two special resolutions. The fir...the sale of all or substantially all of the assets...or in the asset purchase agreement dated November ...
(Date:11/20/2009)...ON, Nov. 20 The United ...nate to make essential changes its health reform b...ion funding and conscience protection on abortion,...include strong provisions for adequate affordabili...e bill an "enormous disappointment" that creates n...
(Date:11/20/2009)... Senators and Congressmen in Competitive Re-elect...Care Vote , Washington, D...ssmen running for re-election next year in races d...Cook, may come to regret voting for House Speaker ...o a breaking Zogby International/ O’Leary Re...
(Date:11/20/2009)... 20 The American Dental...rug Administration (FDA) to establish appropriate ..., Citing concern about the safety of whitening p...nefit of professional consultation or examination ...ation of chemically based tooth whitening or bleac...
(Date:11/20/2009)... Israel, November 20 Car...://www.CVSLMEDICAL.COM , a leading,developer of ad...nounced that,the company,s Board of Directors has ... Canada and the Far East for its proprietary next-...l angioplasty (PCTA) procedures. , Cardio...
Breaking Medicine News(10 mins):Health News:NUCRYST Announces Special Meeting of Shareholders 2Health News:NUCRYST Announces Special Meeting of Shareholders 3Health News:U.S. Bishops Voice Disappointment in Abortion-Funding Provisions in Senate Health Bill, Urge Better Care for Immigrants and Affordability 2Health News:Just 25% of Voters in Competitive 2010 Senate Races “Much More Likely” to Support Pelosi-Democrats Who Voted for Health Care Bill 2Health News:Just 25% of Voters in Competitive 2010 Senate Races “Much More Likely” to Support Pelosi-Democrats Who Voted for Health Care Bill 3Health News:American Dental Association Petitions FDA to Classify, Regulate Tooth-Whitening Products 2Health News:Cardio Vascular Medical Device to Apply for Additional Patents in Europe, Canada and Far East 2
...aeli Agriculture minister Zeev Boim claimed on Sun...ries poultry. // The minister, who came under stro... to the bird flu, said that Israel has taken actio...net he stated that the cost of compensating farmer...
...tudy that is to appear in the May 1, 2006 issue of...ancer Society says that weight training// improves...een treated for breast cancer. A bi-weekly exercis...r, patients experience insomnia, weight gain, chro...
...nder the Revised National TB Control Programme (RN...dardized//, good quality treatment and diagnostic ... that about 50 - 60 % of HIV-positive people are m...esistant cases. He said this after releasing the R...
...ence Minister Pranab Mukherjee has urged the milit...e cutting edge of medical services, in the rapidly... challenges. // Military medical forces are th...he 16th Asia-Pacific Military Medicine Conference ...
...ef Minister of Bihar, Nitish Kumar assured that th...tricting the alarming spread of AIDS/HIV in the st...by the Udayan Sharma foundation, Samyak and the Na...hlighted the need for concerted efforts in creatin...
...with a mild fear of flying should take a deep brea...eir breath for six to 10 seconds, just before take...ssociation of German Psychiatrists (known by its G...ed affected persons to refrain from alcohol and ca...
Other Medicine News:Health News:Israel Claims Eradication Of Bird Flu In Poultry 2Health News:India to Implement National Action Plan against TB-HIV 2Health News:Pranab Mukherjee Urged Military Doctors To Remain On The Cutting Edge 2
...oratories is a national reference laboratory and a...h and development. ARUP offers an extensive test m...clinical and anatomic pathology. Owned by the Univ... more than half of the nation's university teachin...
...oratories is a national reference laboratory and a...h and development. ARUP offers an extensive test m...clinical and anatomic pathology. Owned by the Univ... more than half of the nation's university teachin...
...oratories is a national reference laboratory and a...h and development. ARUP offers an extensive test m...clinical and anatomic pathology. Owned by the Univ... more than half of the nation's university teachin...
...oratories is a national reference laboratory and a...h and development. ARUP offers an extensive test m...clinical and anatomic pathology. Owned by the Univ... more than half of the nation's university teachin...
Medicine Products: