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.
"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