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Baxter International has restructured its agreement with Xenetic Biosciences for the development of BAX 826, a recombinant Factor VIII treatment for haemophilia A, and also made a $10m investment in Xenetic.

The ongoing agreement with Xenetic is for the development of BAX 826 currently under investigation to assess its potential to extend the half-life and duration of effectiveness.

The deal complements the company’s current development programmes, which are focused on improving the pharmacokinetic profile and extending the half-life of blood coagulation factors, including Factor VIII.

Under the restructured deal, Xenetic has agreed to a restructuring of certain financial and timing aspects of its existing partnership with Baxter.

According to the terms of the amended licensing agreement, Baxter has agreed to make contingent milestone payments up to $100m, as well as increased royalties on sales.

Baxter head of global hemophilia organisation Brian Goff said through the Xenetic partnership, the company is seeking to identify and develop a treatment that the majority of hemophilia patients could administer less frequently, potentially at once-weekly intervals, without compromising efficacy.

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"We are focusing our efforts on using a range of technologies to introduce new therapies and enhancements to existing therapies, each designed to improve the patient experience as we pursue our vision of a bleed-free world," Goff added.

"We are focusing our efforts on using a range of technologies to introduce new therapies and enhancements to existing therapies, each designed to improve the patient experience as we pursue our vision of a bleed-free world."

The two firms have previously entered into an exclusive worldwide agreement to develop new forms of polysialylated blood coagulation factors, including Factor VIII, using Xenetic’s proprietary polysialic acid (PSA) technology.

The restructured arrangement further shows Baxter’s long-standing commitment to innovation in haemophilia, and strengthens the company’s broad R&D pipeline focused on a variety of bleeding disorders.

Baxter has also recently completed enrolment in a Phase III clinical trial of BAX 855, its investigational, extended half-life, recombinant Factor VIII (rFVIII) treatment for haemophilia A and expects to file for regulatory approval for BAX 855 in the US by the end of the year.

The company is also currently advancing a number of other treatments and early-stage R&D programmes, including the study of BAX 335, an investigational Factor IX gene therapy treatment for haemophilia B.

A Phase I/II open-label clinical trial to evaluate the safety and optimal dosing schedule of BAX 335 is in progress and the first patients have been dosed.


Image: Deficiency in coagulation factor VIII is the cause of haemophilia A. Photo: courtesy of ProteinBoxBot.