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Hemophilia B Drug Submitted for IND Status Approval

Inspiration Biopharmaceuticals recently filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for IB1001, its recombinant factor IX (rFIX) product for on-demand and prophylactic treatment of patients with hemophilia B. The company, based in Laguna Niguel, CA, submitted the application on November 13, 2007. If approved, Inspiration will initiate clinical trials to evaluate the pharmacokinetics (PK) and safety of IB1001, compared with existing factor IX products. IB1001, which is administered intravenously, has been developed using Inspiration’s patented recombinant protein manufacturing technologies.

Lower-cost manufacturing of the drug may have worldwide impact. "Our cost-effective manufacturing platform for factor IX positions Inspiration to expand the global supply of i.v. rFIX and to develop next generation products to facilitate prophylactic care of the hemophilia B patients worldwide," said Michael Griffith, PhD, President and CEO of Inspiration Biopharmaceuticals. "Our ultimate goal is to leverage our low-cost manufacturing technology to find the means for noninvasive delivery of factor IX, which we believe may represent the equivalent of a therapeutic cure for patients suffering from this disease."

Inspiration plans to follow successful PK studies with multiple clinical trials to measure the efficacy and safety of on-demand treatment, prophylactic therapy and surgery.

In a related development, Cook Pharmica, the contract biopharmaceutical manufacturing and development services division of Cook Medical in Indiana, announced that it signed an agreement with Inspiration to conduct development work for IB1001. Its Bloomington-based development laboratory will eventually manufacture the product.

"We are pleased to be working with Cook Pharmica," added Griffith. "We look forward to our partnership as we prepare for large-scale manufacturing of our factor IX product for the treatment of hemophilia B."

Source: Inspiration Biopharmaceuticals news release dated November 13, 2007 and The News & Observer, November 19, 2007