Baxalta Spins Off from Baxter BioScience

On July 1, Baxter International spun off its Baxter BioScience global biopharmaceutical business into Baxalta, which will focus on developing new treatments for people with orphan diseases and underserved conditions. According to Baxter, Baxalta will build on its strengths in hematology and immunology, while seeking to expand its oncology portfolio for patients with limited treatment options.

With its launch, Baxalta has four products under regulatory review. For hematology, Baxalta will add to its roster of existing products, including Advate (antihemophilic factor [recombinant]) and Feiba (anti-inhibitor coagulant complex [human]), with new offerings that include BAX 855, an extended half-life recombinant factor VIII treatment for hemophilia A to be marketed in the U.S. as Adynovate (antihemophilic factor [recombinant], pegylated). It will also advance a Phase I/II open-label clinical trial assessing the safety and optimal dosing level of a factor IX gene therapy treatment for hemophilia B. For immunology, Baxalta hopes to expand its immune globulin portfolio with HYQVIA (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for adults with primary immunodeficiency. And, for oncology, Baxalta has filed for approvals with the U.S. Food and Drug Administration and European regulators to market MM-398 (irinotecan liposome injection), co-developed with Merrimack Pharmaceuticals for metastatic pancreatic cancer. In March, Baxter and partner CTI BioPharma announced positive Phase III PERSIST-1 trial results for the myelofibrosis treatment pacritinib. In addition, Baxalta plans to add the Oncaspar (pegaspargase) product portfolio for acute lymphoblastic leukemia, which Baxter said in May it was buying from Sigma-Tau Finanziaria. That deal is expected to close in the second half of 2015.

Baxalta employs 16,000 people worldwide and is headquartered in Deerfield, Ill., with a global innovation and research and development center set to open later this year in Cambridge, Mass.