CMC, inspiration in Bulk Bio Pact

CMC Biologics and Inspiration Biopharmaceuticals 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. CMC will be the exclusive manufacturer of bulk IB1001 for at least six years; commercial supply manufacturing is expected to begin this fall. Financial terms were not disclosed.

“We are extremely excited to be the commercial manufacturer of IB1001, an important new therapy option for people with hemophilia B,” said Gustavo F. Mahler, Ph.D., global chief operations officer at CMC Biologics. “This contract represents a key milestone in our commercial manufacturing strategy.”

IB1001 is close to completing the Phase III portion of clinical testing in Europe, the U.S., Israel and India. If approved, 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. The expected filing and approval dates were not disclosed.

“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.”