Baxter International Inc. has announced that it has initiated pre-clinical programs to develop recombinant Factor IX proteins to treat hemophilia B.
Baxter will develop both an unmodified recombinant Factor IX therapy for treatment of acute bleeding episodes and a chemically modified, long-acting version of recombinant Factor IX therapy for prophylaxis of bleeding in hemophilia B patients. Hemophilia B is the second most common type of hemophilia, occurring in one in 25,000 male births and with an estimated 133,000 people living with hemophilia B worldwide.
"Extending our recombinant portfolio beyond ADVATE, which is indicated for the treatment of hemophilia A, to target hemophilia B is a natural progression of our leadership in hemophilia and in providing innovative therapies for rare blood disorders," said Hartmut J. Ehrlich, MD, vice president of global research and development for Baxter's BioScience business. "Our goal is to develop an unmodified version of recombinant Factor IX intended for acute treatment of bleeding episodes in hemophilia B patients as well as to innovate a longer-acting Factor IX therapy for prevention of bleeding episodes. A longer-acting Factor IX may translate into few required infusions, and can help people living with hemophilia B lead a more normal, healthy life."
Pre-clinical work on a longer-acting version of recombinant Factor IX includes an important new partnership with Nektar Therapeutics to use the company's leading PEGylation technology in combination with Baxter's recombinant Factor IX in order to increase the length of time that Factor levels are maintained in the body. Nektar and Baxter have an existing program aimed toward the development of longer acting Factor VIII therapies.
In accordance with generally accepted accounting principles, Baxter expects to record a special pre-tax charge of approximately $5 million for in- process research and development associated with the transaction in the fourth quarter of 2007. In addition, Baxter may make future development and sales milestone-related payments to Nektar.
Baxter Hemophilia Research and Development