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 capabilities," noted Andrew Grethlein, Ph.D., Executive Vice President and Chief Operating Officer at Inspiration Biopharmaceuticals. "We look forward to our continued relationship with CMC Biologics as IB1001 moves toward commercial launch."

About CMC Biologics

CMC Biologics (www.cmcbio.com) is a dedicated contract biopharmaceutical manufacturing and development organization with facilities in Copenhagen, Denmark and Seattle, Washington, USA. CMC Biologics specializes in custom services for scale up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and in-market production. The Company's fully integrated services includes cell line development using its proprietary CHEF1® system, process and formulation development, and comprehensive analytical testing. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers stirred tank and perfusion production processes.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals is the only company exclusively dedicated to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications.  Inspiration has a broad portfolio of recombinant hemophilia products, which includes two late-stage products in clinical development and two pre-clinical programs.

Inspiration's lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII and for individuals with acquired hemophilia.  Both products are in clinical development.  Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.

Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory approval and global commercialization.  The Company's senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.  In addition, in January 2010, Inspiration entered into a long-term strategic partnership with the Ipsen Group, leveraging the combined expertise and resources of the two companies. For further information on Inspiration, please visit http://www.inspirationbio.com.


'/>"/>
SOURCE CMC Biologics
Copyright©2010 PR Newswire.
All rights reserved

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:12/2/2016)... Dec. 2, 2016  The Addiction Treatment Advisory ... of Managed Care Pharmacy (AMCP), has released detailed ... address the opioid addiction crisis, including through improved ... ATAG,s newly released paper, "The Role ... Naloxone," addresses many issues around gaps and barriers ...
(Date:12/2/2016)... 2016 CVS Health Corporation (NYSE: ... York City on Thursday, December 15, 2016, beginning at 8:00 a.m. (ET). ... provide an in-depth review of the company,s strategies to ... will also discuss 2017 earnings guidance during the event. ... event will be broadcast simultaneously on the Investor Relations ...
(Date:12/2/2016)... 2, 2016   CytoSorbents Corporation (NASDAQ: ... European Union approved CytoSorb ® cytokine adsorber to ... worldwide, announced that Dr. Phillip Chan , Chief ... LD Micro Main Event investor conference held from ... Luxe Sunset Boulevard Hotel in Los Angeles, ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... ... "Cardiovascular Health" in USA Today, which covers the innovative treatments, therapeutic technologies, and ... maintaining fulfilling lives. “We are prolonging life 6 years in the last 3 ...
(Date:12/2/2016)... ... 2016 , ... The PAINWeekEnd Regional Conference will be hosted ... Honolulu, offering local frontline clinicians the opportunity to extend their certified continuing medical ... supplemental training related to pain management has surged dramatically in recent years, with ...
(Date:12/2/2016)... ... , ... Sourced from the Isbre Springs beneath the 5,000 year old Hardanger ... of just 6 ppm TDS (Total Dissolved Solids) in addition to its excellent taste ... several ShopRite and FoodTown stores in NJ and received rave comments from consumers. , ...
(Date:12/2/2016)... ... December 02, 2016 , ... Yisrayl Hawkins, at The House ... this current generation fits into Bible Prophecy. Yisrayl says this generation, known as the ... this conclusion, showing how the details line up exactly with Bible Prophecy – a ...
(Date:12/2/2016)... , ... December 02, 2016 , ... ... announced today that it has raised $6.0 million in an initial round of ... Health’s conviction that patients and their caregivers can receive far better care through ...
Breaking Medicine News(10 mins):