Baxter International Spinout Baxalta Finally Has Long Awaited Launch

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DEERFIELD, Ill. – Baxalta Incorporated, a pharmaceutical spinout of Illinois-based Baxter International , finally launched with hopes of fielding 20 new products by 2020, the company announced this morning.

The new company, which trades under the BXLT ticker symbol, will focus on developing products for the hematology, oncology and immunology markets. The launch of Baxalta has been underway for the past two years and the company will break away with a value of $6 billion and a robust portfolio that will help the company meet that 2020 goal.

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, chief executive officer and president, Baxalta Incorporated.

In March 2014, Baxter announced plans to spin out two separate, independent companies. One, Baxalta Incorporated, would focus on developing and marketing biopharmaceuticals. The other company, which retains the Baxter International name, will focus on medical products. Headquartered in northern Illinois, Baxalta employs 16,000 employees worldwide. Baxalta began hiring in March for its new 200,000 square-foot facility in Boston. That center is likely to employ approximately 400 people.

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. The company has more than 40 programs in development, 13 of which are in late-stage development.


In hematology, the company is developing Advate [Antihemophilic Factor (Recombinant)] and Feiba [Anti-Inhibitor Coagulant Complex (Human)]. Additional hematology products include BAX 855, an investigational extended half-life recombinant factor VIII treatment for hemophilia A to be marketed in the United States under the brand name Adynovate [Antihemophilic Factor (Recombinant), Pegylated]. Additionally, Baxalta is advancing a Phase I/II open-label clinical trial assessing the safety and optimal dosing level of an investigational factor IX 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.


In immunology, Baxalta will develop its immune globulin portfolio with the launch of Hyqvia [Immune Globulin Infusion 10 percent (human) with Recombinant Human Hyaluronidase], which will treat of adults with primary immunodeficiency.


For its oncology leg Baxalta will focus on treatments for rare cancers including myelofibrosis, a rare blood cancer, and metastatic pancreatic cancer. To bolster the oncology pipeline Baxter International plunked down $900 million to acquire Oncapar, a promising leukemia treatment from Italian company Sigma-Tau Finanziaria S.p.A. in May.

The company estimates the oncology pipeline will bring in $10 billion once it’s established. Onscapar currently brings in about $100 million annually. That acquisition is just one of the bricks in the company’s foundation. In March Baxter acquired privately held German biopharma SuppreMol for $225 million, which brought that company’s biologic immunoregulatory therapeutics for the treatment of autoimmune diseases into the Baxalta pipeline.

Baxalta is also striking deals with other companies to expand its oncology pipeline. Baxalta entered into partnership with Merrimack Pharmaceuticals Inc. to support Merrimack’s New Drug Application for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas. The drug was granted priority review status by the U.S. Food and Drug Administration (FDA) and is also under review by the European Medicines Agency (EMA).

In addition to Baxalta, Baxter Ventures, the ventures arm of Baxter International, formed Vitesse Biologics, LLC in June. Vitesse will focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology, the company said.

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