New year, new deal

Baxalta, Symphogen ink immuno-oncology collaboration

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BANNOCKBURN, Ill. & COPENHAGEN, Denmark—Baxalta Inc. and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, have announced the beginning of a broad strategic immuno-oncology collaboration.
“This exciting partnership aligns well to Baxalta’s strategy to invest in immuno-oncology and build an innovative portfolio of immunotherapies,” David Meek, executive vice president and president, Oncology, Baxalta, commented in a statement. “With the expertise Symphogen offers in this category and their broad portfolio of early-stage immuno-oncology programs, this collaboration allows us to actively advance one of the most innovative areas of this field. For Baxalta, this is just the beginning of our focus in building world-class capabilities in immuno-oncology.”
Per the terms of the agreement, the two companies will advance novel therapeutics against six checkpoint targets, with the first program slated to begin clinical studies in 2017. Assuming successful completion of Phase 1 clinical trials, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization on a product-by-product basis. In turn, Baxalta will pay Symphogen an upfront payment of $175 million (€160 million) in exchange for the exclusive option rights for six checkpoint therapies. Symphogen will assume responsibility for R&D through Phase 1 clinical trials at its own expense. All told, the agreement could total up to €1.4 billion ($1.6 billion) in option fees and milestones over the long-term, in addition to royalties on worldwide sales. Additional details, including the specific therapeutic targets, were not released.
“Baxalta’s dedication to delivering transformative therapies and its global commercial presence make it an ideal strategic partner for Symphogen, as we complement Baxalta with R&D competencies within the immuno-oncology area,” Dr. Kirsten Drejer, CEO of Symphogen, remarked in a press release. “We look forward to providing Baxalta with innovative immuno-oncology product candidates under this broad collaboration.”
Dr. Göran Ando, chairman of Symphogen’s board of directors, noted that the agreement “provides strong validation for Symphogen’s antibody approach and capabilities within the exciting field of immuno-oncology therapy.”
In other recent news for Baxalta, the company, along with CTI BioPharma Corp., announced the completion of the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The companies are requesting U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter, as well as requesting accelerated approval and a Priority Review of the application.

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