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12:00 AM
Jul 13, 2015
 |  BioCentury  |  Strategy

Baxalta's blueprint

Baxter spinout Baxalta is engaging patients to build its portfolio

Now that Baxalta Inc. has completed its spinout from Baxter International Inc., the newco's ambitious plan is to launch 20 new drugs, including line extensions, by 2020. The products, which come from a mix of recent BD activity and homegrown programs, will employ a revamped R&D strategy that taps patients for input early in development to ensure the end product meets their needs.

Baxter announced plans to spin out its drug pipeline and products into a separate company in March 2014, and the separation became official on July 1 with Baxalta's debut on the New York Stock Exchange. The parent kept its medical product business, while Baxalta emerged from the biopharmaceutical business which was housed in the Baxter BioScience unit.

The newco is focused on three core areas - hematology, autoimmune disease and cancer - and launched with a pipeline of 16 disclosed clinical candidates, and 14 marketed drugs with 2014 net sales of $5.9 billion.

Baxter relied on BD to stock much of Baxalta's pipeline over the past year, which includes four compounds in registration and three in Phase III testing (see "Baxalta's Pipeline," page 21).

Meanwhile, the group that would become Baxalta's management team reorganized the newco's R&D to incorporate patient perspectives throughout the drug development process. The shift was a fundamental change and reflects the company's focus on patient access to drugs that are effective on symptomatic endpoints important to those who are treated as well as on approvable endpoints determined by regulators.

Inherited traits

Baxalta inherited its pipeline and products in hematology and immunology from Baxter; however, the newco has had to build its cancer portfolio via licensing and acquisition deals over the past 15 months.

In the hematology space, Baxalta markets seven products and has seven candidates in the pipeline, five of which are earmarked for approval by 2020 along with the EU approval of Obizur recombinant porcine Factor VIII and a new formulation of Feiba human plasma.

Most of the clinical programs were discovered in-house and focus on rare blood disorders or subgroups of hemophilia patients not well served by available therapies. For example, BAX 855, a pegylated version of the company's Advate recombinant Factor VIII, is under FDA review to treat hemophilia A...

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