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:7/21/2014)... Calif. , July 21, 2014  PowerVision, ... first fluid-based accommodating intraocular lens, today announced that ... Mosbacher, and Law Chair of Ophthalmology, and Professor ... joined the company,s Scientific Advisory Board. ... including the American Academy of Ophthalmology Lifetime Achievement ...
(Date:7/21/2014)... VIEJO, Calif. , July 21, 2014  Avanir ... that the U.S. Food and Drug Administration (FDA) accepted ... Phase II study assessing the safety and efficacy of ... initiate this study evaluating AVP-786 for the adjunctive treatment ... quarter of 2014. "The endorsement of ...
(Date:7/21/2014)... 2014 Integrity Applications, Inc. (OTCQB: IGAP) ... ® model DF-F noninvasive blood glucose measurement ... its wholly-owned subsidiary, Integrity Applications Ltd., into a ... of Acer Inc.  Pursuant to the agreement, Wistron ... non-exclusive basis) the GlucoTrack Model DF-F and any ...
Breaking Medicine Technology:PowerVision Appoints Ophthalmology Thought Leader Douglas D. Koch, M.D. to its Scientific Advisory Board 2PowerVision Appoints Ophthalmology Thought Leader Douglas D. Koch, M.D. to its Scientific Advisory Board 3PowerVision Appoints Ophthalmology Thought Leader Douglas D. Koch, M.D. to its Scientific Advisory Board 4Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder 2Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder 3Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder 4Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder 5Integrity Applications, Inc. Enters into Manufacturing Agreement with Wistron Corp. 2Integrity Applications, Inc. Enters into Manufacturing Agreement with Wistron Corp. 3
(Date:7/22/2014)... MonaVie announces today that nutrition and ... (SAB). The addition of Macdonald will help ensure the ... development plans and necessary substantiation for research and development. ... been with the company as its nutrition and fitness ... MonaVie’s RVL and CORE line ...
(Date:7/22/2014)... (PRWEB) July 22, 2014 Ocean ... center located in Pompano Beach, Florida, has ... the Joint Commission, an independent not-for-profit organization that ... Accreditation signifies that the quality programs offered at ... standards for safety and performance. Ocean Breeze, which ...
(Date:7/22/2014)... Bramal LED announced that they will be featured ... airing later this year via Discovery Channel. Dates and show ... Bramal LED’s T-10 lamps, which provide over 80,000 hours of ... 70 percent. Bramal LED’s T-10 lamps can be plugged into ... on direct AC voltage, with no need for an electrician. ...
(Date:7/22/2014)... July 22, 2014 Chris Carpenter’s ... course that takes a comprehensive, step-by-step approach to teaching ... marketing venture has just been released to the public, ... the internet marketing world if you’re unable to generate ... lot of people simply give up when they find ...
(Date:7/22/2014)... BlackBox Biometrics, Inc. has launched a new ... advancements including a new high-g accelerometer and ... revision of the already robust Blast Gauge System platform, ... blast events by recording a Service member's exposure to ... overpressure that accompany a blast event can cause serious ...
Breaking Medicine News(10 mins):Health News:MonaVie Adds Nutritionist Mark Macdonald to Its Scientific Advisory Board 2Health News:MonaVie Adds Nutritionist Mark Macdonald to Its Scientific Advisory Board 3Health News:Florida Drug and Alcohol Addiction Treatment Center Receives Joint Commission Seal of Approval 2Health News:Florida Drug and Alcohol Addiction Treatment Center Receives Joint Commission Seal of Approval 3Health News:Bramal LED to be featured in Upcoming Episode of Innovations with Ed Begley, Jr. 2Health News:Info Cash 2.0: Review Of Chris Carpenter’s Online Marketing Training Released 2Health News:BlackBox Biometrics®, Inc. continues to advance blast overpressure measurement with release of new Blast Gauge 2Health News:BlackBox Biometrics®, Inc. continues to advance blast overpressure measurement with release of new Blast Gauge 3
... Services, Inc. (NYSE: AHS ), the largest healthcare ... conference call to discuss fourth quarter and year end results ... The company expects to issue an earnings news release ... market at approximately 4:00 p.m. Eastern Time. A live webcast ...
... Homeland Security Chairman Bennie G. Thompson (D-MS) and ... Science and Technology, James R. Langevin (D-RI), released ... Ready for Pandemic Influenza." The report examines the ... the event of a pandemic influenza outbreak. It ...
... with Complex Rehab MarketHOUSTON, Jan. 14 Anne Kieschnik, ... experience, has joined Alliance Seating & Mobility ... rehab companies. Kieschnik is an Assistive Technology Professional ... Houston, Texas, for ASM ( www.alliance-seating.com ) and is ...
... effort focuses on genetics and who would benefit from ... research may one day help physicians identify those patients ... from certain treatments. , The discoveries, paving the way ... U.S. health-care system millions while sparing patients the agony ...
... Ken Thorpe and Alan Aviles, President and Chief ... and Hospitals Corporation, spoke to reporters today about ... in the economic stimulus package. President-elect Barack Obama ... investments necessary to ensure America,s medical records are ...
... Action for Children,s First Annual Awards CeremonyWASHINGTON, Jan. ... honored Senators Richard Lugar (R-IN), Christopher Dodd (D-CT), ... and Betty McCollum (D-MN-04) with the first annual ... award recognizes those who have done outstanding work ...
Cached Medicine News:Health News:AMN Healthcare Services to Host 2008 Fourth Quarter & Year End Earnings Conference Call on Thursday, February 26, 2009 2Health News:Report: Nation Not Ready for Pan Flu 2Health News:Veteran Rehab Specialist, Anne Kieschnik, Joins Fast-Growing Alliance Seating & Mobility In Texas 2Health News:Veteran Rehab Specialist, Anne Kieschnik, Joins Fast-Growing Alliance Seating & Mobility In Texas 3Health News:Researchers Zero In on GI Cancers 2Health News:Researchers Zero In on GI Cancers 3Health News:Researchers Zero In on GI Cancers 4Health News:PFCD Experts Cite Health Information Technology as Key Investment for Economic Stimulus 2Health News:Senators Lugar, Dodd, Boxer and Representatives Lee and McCollum Receive GAC Children's Champion Award 2
Open wire loops decrease the chance of interfering with instruments, Designed to retract the eyelid during ophthalmic microsurgery or minor office procedures...
For rotating nucleus during phacoemulsification, Also useful for dislocating the nucleus into the anterior chamber during extracapsular cataract extraction, 45, Blunt, Forked, 9.0mm from end...
... drape has two perforations which ... to various single or bilateral ... Refractive drape has two perforations ... adapts to various single or ...
Angled 45, 9mm from end, Longer design from bend to tip allows for easier placement of viscoelastic to all meridians, Dome shape, extra smooth tip...
Medicine Products: