Inspiration Biopharmaceuticals recently announced that the company had entered new license, development and commercialization agreements with Ipsen. The agreements restructure the existing partnership with Ipsen and provide Inspiration with additional funding to support development of its two investigational drugs in late-stage development for hemophilia: IB1001 and OBI-1. Ipsen gains the rights to commercialize IB1001 and OBI-1 in Europe, Russia, China, Australia and certain other countries. It will be responsible for future regulatory filings in those countries. Inspiration retains commercialization rights in the Americas, Japan, India, the Middle East, South Africa, Taiwan and certain other countries, as well as global development rights for all products in its product portfolio.
IB1001 is an intravenous recombinant factor IX (rFIX) product being investigated for the treatment and prevention of bleeding episodes in people with hemophilia B. OBI-1 is an intravenous recombinant porcine (pig) factor VIII (rpFVIII) product for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.
“During the last two years, Ipsen’s commitment to hemophilia and their recognition of the value of Inspiration's unique product portfolio have been the basis for a successful collaboration,” said John P. Butler, Chief Executive Officer of Inspiration. “This new arrangement confirms Ipsen’s ongoing commitment to Inspiration, while also enabling Inspiration to become an independent, fully integrated, commercial biopharmaceutical company serving people living with hemophilia.”
In separate news, the US Food and Drug Administration (FDA) placed a clinical hold in July 2012 on phase III clinical trials evaluating the safety and efficacy of IB1001 in adult and pediatric patients. Inspiration had reported to the FDA that a higher-than-expected proportion of individuals treated with IB1001 in clinical trials had developed antibodies to proteins from the Chinese hamster ovary (CHO) cells used to manufacture the therapy. It then notified its clinical sites worldwide to halt treatment of patients. Though no adverse events have been reported in the 86 patients exposed to IB1001, the company is observing trial enrollees and collecting information in collaboration with regulators. “As always, the safety of patients in our clinical programs is our primary concern,” Butler said. “We are conducting a full investigation into the root cause of these antibodies.”
Sources: Inspiration news releases dated July 10 and August 21, 2012