From Baxter springs Baxalta

Baxalta launches with intent to be a ‘global biopharmaceutical leader dedicated to patients with orphan diseases and underserved conditions’

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DEERFIELD, Ill.—Much like Athena springing fully grown (and armed/armored) from the head of Zeus, we have the arrival of Baxalta Inc., a spinout from Baxter International, announced July 1—a company states its mission is “to focus innovation on targeted therapies to advance leadership in hematology and immunology” as well as to expand its oncology business.
OK, it’s not exactly as sudden and unexpected as Athena’s “birth” in Greek mythology. Talks of Baxter splitting its biopharmaceuticals and medical device segments into two independent companies goes back more than a year, specifically to March 2014, when Baxter officially announced those intentions. And for some time now, Baxter has referenced Baxalta by name in news releases, referring to it as a wholly owned subsidiary. Also, in May of this year, as noted by Zacks Investment Research and others, executives from both Baxter and Baxalata gathered for a two-day conference to provide an update on each entity’s financial outlook, new product pipeline and growth prospects.
Where the announcement of Baxalta’s emergence and independence feels somewhat sudden is that if you look at the Baxter International website, at least as of the writing of this article, you wouldn’t really be able to tell anything has changed there—there’s no mention of the spinout even in the news releases. Nor would you note any mention of Baxter in Baxalta’s news release about its launch until the very end in the “About Baxalta” section. All this despite the fact that both companies are still headquartered in the north suburban Chicago area.
In any case, with the announcement, Baxalta noted that it is a global biopharmaceutical company dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and that the company “continues to advance its well-established leadership position in hematology and immunology and seeks to expand its oncology portfolio for patients with limited treatment options. “
The news release also includes the pronouncement that Baxalta plans to launch 20 new products by 2020, all of which is expected to contribute $2.5 billion in sales by 2020, building on a base of $6 billion in annual revenue already.
“Baxalta launches with a rich heritage in pioneering innovations and strategic partnerships, which positions us well to continue to develop transformative therapies. What sets us apart is our uncompromising focus on understanding patients’ needs and experiences every step of the way,” said Ludwig Hantson, CEO and president of Baxalta. “We are leveraging science and external innovation to spark discovery and work with all stakeholders—patients, healthcare professionals and policymakers—to ensure access and improve standards of care.”
Baxalta notes that it “offers a diverse and differentiated portfolio of trusted brands” and “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.”
In the past two years, Baxalta has seen the issuance of seven new approvals and has four products under regulatory review across its three areas of focus right now.
For the hematology arena, Baxalta is developing such products as Advate [Antihemophilic Factor (Recombinant)] and Feiba [Anti-Inhibitor Coagulant Complex (Human)]. Baxalta is also 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 United States under the brand name Adynovate [Antihemophilic Factor (Recombinant), Pegylated].
The immunology segment of the company’s pipeline is currently riding on the successful launch of Hyqvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase], a therapy for the treatment of adults with primary immunodeficiency.
And, 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.” Baxalta also recently announced the acquisition of the Oncaspar (pegaspargase) product portfolio for acute lymphoblastic leukemia, which is expected to close in the second half of 2015.
Baxalta’s notes that in total, it has more than 40 programs in development, 13 of which are in late-stage development, all of which have the support not only of the Illinois-based corporate headquarters but also a Global Innovation and R&D Center located in Cambridge, Mass., a well-established pharma and biotech hub.
Baxalta noted in particular a Phase 1/2 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 also notes that it 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 U.S. 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.
As noted by Biospace and other media outlets, Baxter has been active outside of the Baxalta work in terms of new company formation. In June, Baxter Ventures, the ventures arm of Baxter International, formed Vitesse Biologics LLC, which will focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology and oncology.
As Zacks noted when it talked about Baxter and Baxalta’s two-day conference in May, “Following the anticipated spin-off, both Baxter and Baxalta are likely to benefit from enhanced financial flexibility and reduced complexity, resulting in strong balance sheets and cash flows.” Zacks also noted, among other things, that in conjunction with the spin-off, Baxter was to receive about $4 billion through a cash dividend from Baxalta and will retain a nearly 20-percent equity stake in Baxalta.

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