Navigation Links
Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs
Date:4/29/2008

- Company on Schedule to Have Two Follow-on Biologics in Clinical Studies

by Year-End

- Enrollment On Track in MMD Clinical Study

- ALS Expanded Access Program Continues to Enroll - Insmed Generates $2.3 million in Cost Recovery Revenue Through Expanded

Access Program for IPLEX(TM) in Italy

RICHMOND, Va., April 29 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOBs) and biopharmaceuticals, today provided an update of the status of its initial FOB development candidates, INS-19 (a FOB of Neupogen(R)) and INS-20 (a FOB of Neulasta(R)) which represent combined 2007 sales of over $4 billion. The Company also reported recent progress made with its IPLEX(TM) development program.

Follow-On Biologics Program

Insmed recently received regulatory approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a clinical trial for Insmed's most advanced FOB candidate, INS-19. Pre-clinical pharmacological, pharmacokinetic and toxicological studies have demonstrated that INS-19 and FDA-approved Neupogen(R) are comparable, and detailed analytical characterisation has also demonstrated that the products have a high degree of similarity. Screening for participants for the Phase 1 study has begun, with dosing of the first patient expected in May 2008. Data to support human similarity is expected in July 2008.

Insmed's second FOB product candidate, INS-20, has also completed pre- clinical pharmacological and pharmacokinetic studies, which have demonstrated that INS-20 and FDA-approved Neulasta(R) are comparable. Detailed analytical characterisation has also demonstrated that the products have a high degree of similarity. The Company intends to initiate clinical studies for INS-20 in the fourth quarter of 2008.

Insmed also has several other FOB products which are currently at
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy
2. Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis
3. Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics
4. Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)
5. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
6. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
7. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
8. Raptor Pharmaceuticals Provides Update of Product Programs
9. Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
10. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
11. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... Sep. 03, 2015 Research ... the "Investigation Report on China,s Trastuzumab Market, 2010-2019" ... Genentech, trastuzumab was approved by FDA to be used ... name of Herceptin, a major product of Roche. In ... billion around the world. After entering ...
(Date:9/3/2015)... , Sep. 03, 2015 ... announced the addition of the "Global Craniomaxillofacial ... offering. The global craniomaxillofacial devices market ... 2014-2019. This report covers the present and ... for 2015-2019. To calculate the market size, we ...
(Date:9/3/2015)... 3, 2015 China,s ... Monitoring Patch, a wearable medical device that can continuously ... data, providing safety guidance for pregnant women. The device ... The device, which measures 4 centimeters in diameter, is ... little more than an Apple earphone cord. The small ...
Breaking Medicine Technology:Investigation Report on China's Trastuzumab (Genentech) Market, 2010-2019 2Global Craniomaxillofacial (CMF) Devices Market 2015-2019 - Product Innovation and Cost Reduction a Key Market Trend 2Modoo to Debut at Kickstarter: First Device on the Market that Enables Continuous Monitoring of Fetal Heart Rate and Fetal Movement 2
... 25, 2011 Newport Audiology Centers announced ... Colorado, to Nashville, Tennessee. The new Nashville Operations Center ... its key partners and expand operations across their consumer, ... are very excited by the opportunities Nashville will bring," ...
... China, July 25, 2011 /PRNewswire-Asia/ -- The whole healthcare ... technology trends and social economic increases. Generally speaking, several ... rapid increase of world population especially the aging ... are increasing in both developed and developing countries. They ...
Cached Medicine Technology:Avoid Illness Through Easy Daily Check 2
(Date:9/3/2015)... ... , ... William Mattar Law Offices is known for its slogan “Helping People, ... any certain demographic or segment of the population. Because of this, the firm ... commercials. , The closed captioning will allow people with hearing impairments or who are ...
(Date:9/3/2015)... ... September 03, 2015 , ... The Beryl ... Conference 2016, to be held April 13-15 at Sheraton Hotel in Dallas, Texas. ... together the collective voices of healthcare leaders, staff, physicians, patients and families across ...
(Date:9/3/2015)... ... September 03, 2015 , ... DriButts, a non-profit organization dedicated ... Product Development Group to manufacture a long-lasting reusable diaper for warm weather climates ... to bring 600 DriButts Diapers to rural areas of Haiti during a trip ...
(Date:9/3/2015)... ... ... Real Time Pain Relief (RTPR), makers of the popular rub-on pain ... an official endorsement deal with the company. Originally from New South Wales, Australia, Mason ... 15. He is an Australian bull riding champion, following in his uncles’ footsteps in ...
(Date:9/3/2015)... ... September 03, 2015 , ... IQ Formulations ... for 2015 by economic development group GrowFL and the Edward Lowe Foundation. The ... selected for this prestigious award, which recognizes growing second-stage companies “that demonstrate high ...
Breaking Medicine News(10 mins):Health News:Law Firm Focused on “Helping People” Continues to Expand on Vision 2Health News:Patient Experience Conference 2016 Program Announced by The Beryl Institute 2Health News:Patient Experience Conference 2016 Program Announced by The Beryl Institute 3Health News:DriButts Diapers Rely on Slingshot Help in Haiti 2Health News:DriButts Diapers Rely on Slingshot Help in Haiti 3Health News:Real Time Pain Relief Sponsors the Talented PBR Bull Rider from Down Under - David Mason 2Health News:Real Time Pain Relief Sponsors the Talented PBR Bull Rider from Down Under - David Mason 3Health News:IQ Formulations Hailed Among Florida Companies to Watch for 2015 2Health News:IQ Formulations Hailed Among Florida Companies to Watch for 2015 3
... for Dental Research (AADR) is presenting an honorary membership ... at the AADR/Research!America Advocacy Day, March 2, 2010, in ... his commitment to the National Institutes of Health (NIH) ... (NIDCR). He remains one of the Senate,s most staunch ...
... that reward workers for meeting certain performance measures for ... use a variety of methods to reward physicians financially ... A new study in the Journal for ... be effective in incentivizing low performing physicians. The article ...
... aimed at helping with planning efforts for a public ... the Harvard School of Public Health (HSPH) have found ... significant anthrax attack in their city or town, most ... obtain prophylactic antibiotics. However, a significant minority of those ...
... ... was featured in a national study of high performance services firms entitled “The High Growth ... , ... 2010 -- Webmarketing 123, a San Francisco Bay Area based search engine marketing firm, was ...
... suggests , FRIDAY, Feb. 19 (HealthDay News) -- In the ... identified a defective signaling pathway that contributes to the severity ... sticky mucus to build up in the lungs and digestive ... genetic diseases in children and young adults. , In the ...
... HRT use explain the trend, researchers say , FRIDAY, ... declining, especially among women over 50 who have estrogen ... the reason why. , After analyzing data on more ... that the decline may be linked with decreasing use ...
Cached Medicine News:Health News:AADR presents honorary membership to Senator Tom Harkin 2Health News:Poll: Hypothetical anthrax attack and antibiotics 2Health News:Poll: Hypothetical anthrax attack and antibiotics 3Health News:Poll: Hypothetical anthrax attack and antibiotics 4Health News:Poll: Hypothetical anthrax attack and antibiotics 5Health News:Poll: Hypothetical anthrax attack and antibiotics 6Health News:Webmarketing 123 Profiled in National Study of High Growth Professional Services Firms 2Health News:Webmarketing 123 Profiled in National Study of High Growth Professional Services Firms 3Health News:Drug Improved Survival in Mice With Cystic Fibrosis 2Health News:Dips in Breast Cancer Rates Seen Most in Affluent Women 2Health News:Dips in Breast Cancer Rates Seen Most in Affluent Women 3
... of the ELECTRA 1400C are designed to ... walkaway capabilities. This system includes automated primary ... and factor assays in a single setup. ... and automatic preparation of reference curves and ...
... to maximize your testing options even when ... fully automated system offers superior technology, such ... to ensure testing accuracy and efficiency in ... backed by our high-quality service to help ...
... The SYNCHRON CX9 ALX system is ... time-consuming manual processes by as much as ... lower your total costs. Featuring the AccuSense® ... and an expanded test menu, the CX9 ...
... SYNCHRON CX4-S system consolidates DATs, ... in one workstation, targeted to ... 50-200 samples per day. Like ... the CX4-S is easy to ...
Medicine Products: