Baxalta: Examining the Product and Manufacturing Positions of the New Baxter Spinoff

Baxalta, the newly spun-off company from Baxter Healthcare, has launched as a new separate, independent $6 billion biopharmaceutical company. So what are the product and manufacturing positions of the new company and the executive team that will lead the new company? DCAT Value Chain Insights takes an inside look.

Baxter announced in March 2014 that it was separating into two independent companies, one focused on biopharmaceuticals (now Baxalta) and a second on medical products (keeping the Baxter name). Baxalta is focused on innovator drug research and development and commercialization of biopharmaceuticals, and Baxter will keep its focus on manufacturing intravenous (IV) solutions and administration sets, premixed drugs and drug-reconstitution systems, pre-filled vials and syringes for injectable drugs, IV nutrition 

Inside Baxalta
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. Baxalta is headquartered in Bannockburn, Illinois, and the Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. 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. Baxalta employs 16,000 employees worldwide and is led by Ludwig N. Hantson, PhD, as president and chief executive officer of Baxalta and who also serves on the company's board of directors. Prior to Baxalta's separation from Baxter in July 2015, he was corporate vice president and president of Baxter BioScience, having served in that capacity since October 2010. Ludwig joined Baxter in May 2010 as corporate vice president and president, international. From 2001 to May 2010, Dr. Hantson held various positions at Novartis Pharmaceuticals Corporation, the last of which was chief executive officer, Pharma North America. Prior to Novartis, Dr. Hantson spent 13 years with Johnson & Johnson in roles of increasing responsibility in marketing and clinical research and development. 

The therapeutic focus of Baxalta is in hematology, immunology, and oncology .Baxalta's portfolio includes a variety of additional differentiated therapies for the treatment of bleeding disorders and chronic and acute medical conditions, including hemophilia A, hemophilia B, acquired hemophilia, inhibitor treatments, primary immunodeficiency (PID) and alpha-1 antitrypsin deficiency. Baxalta is also investing in new disease areas, including oncology, as well as emerging technology platforms, including gene therapy and biosimilars. 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. Overall, Baxalta has more than 40 programs in development, 13 of which are in late-stage development.

Product positions
Baxalta's core disease therapies include: Advate (antihemophilic factor [recombinant]), a recombinant factor VIII (rFVIII) therapy for the treatment of children and adults with hemophilia A; Feiba (anti-inhibitor coagulant complex), an inhibitor management therapy; Gammagard liquid (immune globulin intravenous [human]), a liquid formulation of the antibody-replacement therapy for the treatment of immune deficiencies and certain neurological disorders; and Hyqvia (immune globulin infusion 10% [human]) with recombinant human hyaluronidase), an immune globulin with a recombinant human hyaluronidase for the treatment of PID in adults.

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 with key 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.

Key recent acquisitions and partnerships
Baxalta has enhanced its product positions through targeted acquisitions and collaborations. In March 2015, Baxalta acquired SuppreMol GmbH, a biopharmaceutical company based in Germany with an early-stage development portfolio of treatment options for autoimmune and allergic diseases, focusing on the modulation of Fc receptor signaling pathways, an immune target that could have broad applications in autoimmune disorders. SuppreMol's pipeline includes its lead candidate, SM101, an investigational immunoregulatory treatment that has completed Phase IIa studies in idiopathic thrombocytopenic purpura (ITP), a disorder causing low platelet levels and systemic lupus erythematosus (SLE), a disorder in which the immune system attacks healthy tissue.

In June 2014, Baxalta acquired AesRx, LLC , obtaining AesRx's program related to the development and commercialization of treatments for sickle cell disease (SCD), including BAX 555 (f/k/a Aes-103), an investigational prophylactic treatment for SCD currently in a Phase II clinical trial as part of an ongoing collaboration with the National Institute of Health (NIH)'s National Center for Advancing Translational Sciences (NCATS) through its Therapeutics for Rare and Neglected Diseases (TRND) program. In April 2014, Baxalta acquired Chatham Therapeutics, gaining broad access and intellectual property rights to its gene-therapy platform for the treatment of hemophilia B (BAX 335, currently in Phase I clinic trials) as well as a preclinical hemophilia A program, and the potential future application to additional hemophilia treatments.

In September 2014, Baxalta entered into an exclusive license and collaboration agreement with Merrimack Pharmaceuticals, for the development and commercialization of nanoliposomal irinotecan injection, or nal-IRI (MM-398), an investigational drug candidate for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy, for all potential indications outside the United States and Taiwan. A Phase III trial has been completed, and Baxalta filed for approval for second-line pancreatic cancer in the European Union (EU) in May 2015. In November 2014, FDA granted nal-IRI Fast Track designation for the treatment of patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based therapy. Fast track designation is designed by the US Food and Drug Administration (FDA) to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

Baxalta also has several pacts in biosimiars. It has a collaboration with Coherus BioSciences, Inc. to develop and commercialize CHS-0214/BAX 2200, a biosimilar product candidate for Enbrel (etanercept), indicated for the treatment of certain autoimmune deficiencies, in Europe, Canada, Brazil, and other markets. This is Baxalta's most advanced biosimilar, currently in Phase III clinical trials for rheumatoid arthritis and psoriasis. In early-stage clinic trials, Coherus has demonstrated pharmacokinetic equivalence versus the innovator molecule, according to information from the company.

Baxalta is also collaborating with Momenta Pharmaceuticals, Inc. on the development and commercialization of M923/BAX 2923, a biosimilar product candidate for Humira (adalimumab), which is currently in early-stage development. In December 2014, a European clinical trial application for M923/BAX 2923 was accepted. In June 2015, Baxalta entered into an agreement with SFJ Pharmaceuticals Group relating to M923/BAX 2923, whereby SFJ will fund up to $200 million of specified development costs related to Baxalta's M923/BAX 2923 program in exchange for payments in the event the product obtains regulatory approval in the United States and/or Europe. The contingent success payments, which would total approximately 5.5 times the incurred development costs, would be paid in installments over several years following the date(s) of regulatory approval.

On the innovator side. Baxalta acquired rights under a worldwide licensing agreement with CTI BioPharma Corp. (f/k/a Cell Therapeutics, Inc.) to develop and commercialize pacritinib (BAX 2201), a an investigational JAK2/FLT3 inhibitor that recently completed Phase III trials for myelofibrosis, a chronic, malignant bone marrow disorder, and is currently in Phase II trials for acute myeloid leukemia. Baxalta has exclusive commercialization rights for all indications outside the United States, and will jointly commercialize pacritinib in the United States with CTI BioPharma. Positive top-line results from the Phase III trials were announced in March 2015.

In 2013, Baxalta acquired the investigational hemophilia compound and related assets from Inspiration BioPharmaceuticals, Inc. (Inspiration), as well as certain other assets, including manufacturing operations, from Ipsen Pharma S.A.S. in conjunction with Inspiration's bankruptcy proceedings. In October 2014, Obizur was approved for the treatment of acquired hemophilia A in the United States and is currently under regulatory review in Europe and Canada.

In established products in 2010, Baxalta acquired exclusive distribution and licensing rights in the United States, Australia, New Zealand, and Canada to Glassia, a ready-to-use liquid alpha1-proteinase inhibitor used to treat alpha-1 antitrypsin deficiency, through an agreement with Kamada Ltd., together with a technology transfer allowing Baxalta to implement Kamada's related production technology.

Another pact involves Hyqvia, a product consisting of human normal immunoglobulin (IG) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics, Inc. in 2007). Hyqvia was approved in Europe in 2013 for adults with PID syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections, and also in the United States in 2014 for adults with PID.

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