Baxalta Launches as New Biopharm Spinoff from Baxter
Baxalta Incorporated, the spin-off and now wholly owned subsidiary of Baxter International, launched as a separate, independent $6 billion biopharmaceutical company on July 1, 2015. Baxter announced in March 2014 that it was separating into two independent companies, one focused on biopharmaceuticals and a second on medical products. The therapeutic focus of Baxalta is in hematology, immunology, and oncology. Baxalta said it plans to launch 20 new products by 2020. Over the past two years, Baxalta has received seven new approvals and currently has four products under regulatory review across its three areas of focus.
In hematology, the company is advancing its position with on-market products, including Advate [antihemophilic factor (recombinant)] and Feiba [anti-inhibitor coagulant complex (human)]. Key pipeline products of Baxalta are BAX 855, an investigational extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A to be marketed in the United States under the brand name Adynovate [antihemophilic factor (recombinant), pegylated].
In immunology, Baxalta if focused on its differentiated immune globulin portfolio withkey products being Hyqvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase], for treating adults with primary immunodeficiency.
In oncology, the company's late-stage pipeline is focused in rare diseases and complex therapeutics to address patients with high unmet need and difficult-to-treat cancers, including myelofibrosis, a rare blood cancer, and metastatic pancreatic cancer. In addition, Baxalta recently announced the acquisition of the Oncaspar (pegaspargase) product portfolio for acute lymphoblastic leukemia, a deal that is expected to close in the second half of 2015.
Overall, Baxalta has more than 40 programs in development, 13 of which are in late-stage development. The company also recently acquired technology platforms in the fields of immunology and hematology, including the acquisition of SuppreMol for autoimmune and allergic diseases and AesRx for sickle cell disease. Baxalta continues to expand its oncology pipeline through strategic partnerships, such as its partnership with Merrimack Pharmaceuticals, Inc. Merrimack's new drug application for MM-398 (irinotecan liposome injection) or “nal-IRI” for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy was recently accepted for review by the US Food and Drug Administration and granted priority review status, and in parallel, an application for European approval is under review by the European Medicines Agency.
Baxalta's therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including recombinant production and plasma fractionation. Headquartered in Deerfield ,Illinois, and the T Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Baxalta employs 16,000 employees worldwide.