Navigation Links
CMC Biologics Enters Commercial Supply Agreement with Inspiration Biopharmaceuticals for IB1001
Date:9/20/2011

SEATTLE, COPENHAGEN, Denmark and LAGUNA NIGUEL, Calif., Sept. 20, 2011 /PRNewswire/ -- CMC Biologics and Inspiration Biopharmaceuticals ("Inspiration") today announced that the two companies have entered into a long-term commercial supply agreement for the manufacture of bulk IB1001, Inspiration's intravenous recombinant factor IX (rFIX) product, for the treatment and prevention of bleeding in individuals with hemophilia B. Under the terms of the agreement, CMC Biologics will be the exclusive manufacturer of bulk IB1001 for at least six years. CMC Biologics expects commercial supply manufacturing to begin this fall. Other terms of the agreement were not disclosed.

(Logo:  http://photos.prnewswire.com/prnh/20110920/SF71004LOGO)

(Logo:  http://photos.prnewswire.com/prnh/20110502/SF93356LOGO)

"We are extremely excited to be the commercial manufacturer of IB1001 – an important new therapy option for people with hemophilia B," stated Gustavo F. Mahler, Ph.D., Global Chief Operations Officer at CMC Biologics. "This contract represents a key milestone in our commercial manufacturing strategy."

IB1001, Inspiration's lead product candidate is close to completing the Phase 3 portion of clinical testing in Europe, the United States, Israel, and India. Pending the outcome from these clinical studies and subsequent regulatory approvals, IB1001 is expected to be the second recombinant FIX product to come to the market for hemophilia B, providing additional product supply and eliminating reliance by the hemophilia community on a single-source supplier of recombinant product.

"We have worked with CMC Biologics on the process development and manufacture of clinical product supply of bulk IB1001 over the past five years, and we have great confidence in their development and manufacturing capabi
'/>"/>

SOURCE CMC Biologics
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Pinnacle Biologics Appoints ALKOPHARMA SA Its Exclusive Distributor For PDT (Photodynamic Therapy), in Select European Countries, Middle East And South East Asian Territories
2. Aperion Biologics Invited to Present at the UBS Global Life Sciences Conference
3. CMC Biologics Adds 2,000 Liter Single-Use Bioreactor at its Copenhagen Manufacturing Facility
4. Oncobiologics, Inc. and Fox Chase Cancer Center Announce Co-Development of a Novel Cancer Therapy Platform
5. Amgen Announces PDUFA Date for XGEVA® Supplemental Biologics License Application
6. Needle-Free Drug Delivery: The Market for Alternatives to Needle-Based Systems for Vaccine and Biologics
7. ShangPharmas Biologics Division Announces Accelerated Achievement of Milestones for Two Multi-Stage Projects
8. United Kingdom Orthopedic Devices Market Outlook to 2017 - Joint Reconstruction, Spinal Surgery, Orthobiologics, Trauma Fixation and Others
9. Avaxia Biologics, Inc. Awarded BARDA Contract for Therapeutic Countermeasure to Help the Nation Respond to a Radiological Emergency
10. China Orthopedic Devices Market Outlook to 2017 - Joint Reconstruction, Spinal Surgery, Orthobiologics, Trauma Fixation and Others
11. Canada Orthopedic Devices Market Outlook to 2017 - Joint Reconstruction, Spinal Surgery, Orthobiologics, Trauma Fixation and Others
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... QPID Health , a leader in clinical intelligence software, today ... and their first West Coast location in San ... in Boston , and will house product development, ... Southern California office will be located at 1000 ... demands of customers nationwide.  Both new locations will be operational ...
(Date:9/16/2014)... Resources Group finds that the rheumatoid arthritis (RA) disease-modifying antirheumatic drug ... billion in 2023 in the United States , ... Italy , Spain , the ... TNF-alpha inhibitors will remain the leading drug class in both sales ... constrained and patient shares will decline due to the uptake of ...
(Date:9/16/2014)... 16, 2014  Formex, LLC ("Formex"), a ... Mr. Greg Weilersbacher joined Formex as Director of ... Greg Weilersbacher has over ... expertise in Quality Assurance, Facility Validation, GMP ... brings to Formex a diverse wealth of ...
Breaking Medicine Technology:QPID Health Announces Major Office Expansion in Boston and Opens Facility in San Diego 2The Rheumatoid Arthritis Drug Market Will Grow to $18.2 Billion in 2023, Driven by the Uptake of Oral Jak Inhibitors and Non TNF-alpha Biologics 2The Rheumatoid Arthritis Drug Market Will Grow to $18.2 Billion in 2023, Driven by the Uptake of Oral Jak Inhibitors and Non TNF-alpha Biologics 3Greg Weilersbacher Joins Formex, LLC As Director of Quality Assurance and Quality Control 2
... US Phase II Clinical Trials for Organ Transplantation, ... announces positive Phase I clinical results for,its transplantation ... clinical trials for organ transplantation. , Today LifeCycle ... I clinical trial program of LCP-Tacro, a,proprietary, once-daily ...
... Hemispherx Biopharma, Inc.,(AMEX: HEB), a biopharmaceutical company ... new drug entities for pandemic,disease threats, announced ... therapeutic product candidate Alferon-LDO in,combating highly pathogenic ... Alferon-LDO is a low-dose experimental oral formulation,of ...
Cached Medicine Technology:LifeCycle Pharma Announces Positive Phase I Clinical Results for,its Transplantation Product Candidate, LCP-Tacro 2LifeCycle Pharma Announces Positive Phase I Clinical Results for,its Transplantation Product Candidate, LCP-Tacro 3Hemispherx Presents Potential Avian Influenza Treatment,Breakthrough at Paris Conference 2Hemispherx Presents Potential Avian Influenza Treatment,Breakthrough at Paris Conference 3Hemispherx Presents Potential Avian Influenza Treatment,Breakthrough at Paris Conference 4
(Date:9/16/2014)... abnormalities in the adrenergic and noradrenergic systems, both ... play a role in the development of post-traumatic ... no genetic evidence of this connection. A collaborative ... Mailman School of Public Health and the University ... gene and childhood adversity. For individuals with two ...
(Date:9/16/2014)... (PRWEB) September 16, 2014 Beginning October 1st ... a new service offering for its clients who book a ... the volume of business they buy. Most recurring visit ... during the work week, but others include clients whose unique ... pet sitter on a daily basis. The newly ...
(Date:9/16/2014)... 16, 2014 The Pain Center ... by Ranking Arizona magazine, has selected Analance ™, ... enterprise. , With TPC seeing hundreds of thousands ... repository that was managed through “home grown” systems trying ... and clinical leadership teams. “Our current tools were ...
(Date:9/16/2014)... 2014 Founded by former Miami Beach ... a political organization fighting to legalize medical marijuana in ... The After Party recently commissioned a shot-for-shot parody video ... from the movie “Grease.” ( http://youtu.be/zdcvhUgeDRg ) , Called ... the musical parody faithfully recreates the carnival scene made ...
(Date:9/16/2014)... 16, 2014 Synergy Research Group has ... gives the best detail and analysis of the state ... a variety of sources, including Ministry of Health in ... will give readers actionable intelligence on clinical trials in ... relied on by the local and international life science ...
Breaking Medicine News(10 mins):Health News:Evidence of genetic link to PTSD in soldiers exposed to childhood trauma 2Health News:Evidence of genetic link to PTSD in soldiers exposed to childhood trauma 3Health News:Dallas-based Park Cities Pet Sitter Introduces New 15-Minute Visit for Clients on Recurring Visit Schedules. 2Health News:Dallas-based Park Cities Pet Sitter Introduces New 15-Minute Visit for Clients on Recurring Visit Schedules. 3Health News:The Pain Center of Arizona (TPC) Implements Analance™ BI for Actionable Intelligence 2Health News:The Pain Center of Arizona (TPC) Implements Analance™ BI for Actionable Intelligence 3Health News:Miami Beach Politician Drives 1,400 Miles to Texas to Shoot “Grease” Parody Video Supporting the Legalization of Medical Marijuana in Florida 2Health News:Synergy Research Group Debuts Ukraine Orange Paper 2
... , THURSDAY, Jan. 6 (HealthDay News) -- The ... death in newborn intensive care units (NICUs) would be eligible ... infants and young children, according to a new study. ... of the more than 200,000 people in the United States ...
... By Steven Reinberg HealthDay Reporter , WEDNESDAY, Jan. ... February 2007 must be reviewed by the U.S. Food and ... the agency announced Wednesday. This effort, one aspect of ... meant to keep more addictive products from the hands of ...
... non-profit organization focused on supporting innovative early career ... its fall Fellowship Award Committee review. The ... postdoctoral scientists conducting basic and translational cancer research ... the country. The Fellowship encourages the nation,s most ...
... Jan. 5 (HealthDay News) -- Women with multiple sclerosis are ... gene thought to be connected to the condition, a new ... more insight into the development of MS, which is becoming ... Although no one knows what causes MS, scientists suspect that ...
... lateral sclerosis (ALS), and frontotemporal lobar degeneration (FTLD) are ... that include an RNA-binding protein called TDP-43. This protein ... by these clumps. In a study published ... team led by Virginia M.-Y. Lee, PhD, director of ...
... China are reporting development of a less expensive, more eco-friendly ... it may be a more healthful form of water. Their ... Chemistry Research . Changgong Meng and Feng Huang ... a mixture of H2O and tiny amounts of D2O ...
Cached Medicine News:Health News:Infant Organ Donors Could Help Meet Transplant Needs: Study 2Health News:FDA Launches Review of Tobacco Products 2Health News:Damon Runyon Cancer Research Foundation awards prestigious fellowships to 12 top young scientists 2Health News:Damon Runyon Cancer Research Foundation awards prestigious fellowships to 12 top young scientists 3Health News:Damon Runyon Cancer Research Foundation awards prestigious fellowships to 12 top young scientists 4Health News:Study Sheds Light on Genetic Risk of MS 2Health News:Malfunctioning gene associated with Lou Gehrig's disease leads to nerve-cell death in mice 2
Stylet tube, endotracheal, sterile, stainless steel, malleable, one size, overall length 13"(33cm)....
SunGlide™ Stylette - Green Adult. Use in 7.0 to 10mm tubes. 25/box....
SunGlide™ Stylette - Blue Neonatal. Use in 2.0 to 3.5mm tubes. 25/box....
Disposable Aluminum Satin Finish E/T Stylette, Adult 16, 25/box....
Medicine Products: