Baxalta has launched as a global biopharmaceutical company dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions. The company continues to advance in hematology and immunology and seeks to expand its oncology portfolio for patients with limited treatment options. Baxalta plans to launch 20 new products by 2020, leveraging the company’s existing global capabilities and footprint in more than 100 countries.
Baxalta offers a diverse and differentiated portfolio of trusted brands. The company has pioneered several innovations in recombinant protein therapies for hemophilia and other rare blood disorders, and was the first to make human plasma available for treatment. 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 leadership position with sustainable growth of on-market products, including ADVATE [Antihemophilic Factor (Recombinant)] and FEIBA [Anti-Inhibitor Coagulant Complex (Human)]. Baxalta also is bringing next-generation products, including BAX 855, an investigational extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A to be marketed in the U.S. under the brand name ADYNOVATE [Antihemophilic Factor (Recombinant), Pegylated].
In immunology, Baxalta expects to capitalize on its broad and differentiated immune globulin portfolio with the successful launch of HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase], an innovative therapy for the treatment of adults with primary immunodeficiency.
In oncology, the company’s late-stage pipeline capitalizes on its expertise and capabilities 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 (ALL), which is expected to close in the second half of 2015.
Baxalta continues to transform its innovation strategy and has shifted its investments toward new external partnerships and flexible models to accelerate drug discovery and development. World-class scientists, advanced technology platforms and a patient-focused model that examines the underlying biology of disease to define novel mechanisms of actions are at the core of Baxalta’s R&D model. The company has more than 40 programs in development, 13 of which are in late-stage development.
Baxalta is advancing several breakthrough innovations that have the potential to transform the way hemophilia patients are treated. The company currently is advancing a phase I/II open-label clinical trial assessing the safety and optimal dosing level of an investigational factor IX (FIX) gene therapy treatment for hemophilia B that has the potential to redefine the treatment of hemophilia by providing a mechanism for the patient's own liver to begin producing FIX over an extended period.
The company also recently acquired novel 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. 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 FDA and granted Priority Review status, and in parallel, an application for European approval is under review by the EMA.
The Baxalta Global Innovation and R&D Center is located in Cambridge, Mass. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.