Baxter Announces Restructured Agreement with Xenetic Biosciences, Further Bolstering Its Broad Bleeding Disorder Pipeline

Press Release:
  Jan 31, 2014 — DEERFIELD, Ill. -- Baxter International Inc. (NYSE:BAX) has restructured its ongoing agreement with Xenetic Biosciences, Inc. (OTCBB: GAIFD) for the development of BAX 826, a recombinant Factor VIII treatment for hemophilia A under investigation to assess its potential to extend the half-life and duration of effectiveness. This program complements the company's current development programs, which are focused on improving the pharmacokinetic profile and extending the half-life of blood coagulation factors, including Factor VIII.

''Through our Xenetic partnership, we are 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,'' said Brian Goff, head of Baxter's global hemophilia organization. ''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.''

Xenetic and Baxter previously established an exclusive worldwide agreement to develop novel forms of polysialylated blood coagulation factors, including Factor VIII, using Xenetic's proprietary polysialic acid (PSA) technology. Under the terms of the restructured arrangement, Baxter will make an equity investment in the common stock of Xenetic and has agreed to make contingent milestone payments as well as pay royalties on future sales.

This agreement further demonstrates Baxter's long-standing commitment to innovation in hemophilia, and bolsters the company's broad R&D pipeline focused on a variety of challenging bleeding disorders. For example, Baxter recently announced the completion of enrollment in a Phase III clinical trial of BAX 855, its investigational, extended half-life, recombinant Factor VIII (rFVIII) treatment for hemophilia A. The company continues to expect to file for regulatory approval for BAX 855 in the United States by the end of 2014.

The company is also advancing a number of other treatments and early-stage R&D programs, including the study of BAX 335, an investigational Factor IX gene therapy treatment for hemophilia B. The vector-based technology, which provides a mechanism for the patient's own liver to begin producing Factor IX following a single dose of the genetically engineered treatment, has the potential to re-define the concept of longer-acting therapy. A Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of BAX 335 is underway and the first patients have been dosed.

About Baxter in Hemophilia

Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning developments to Baxter's R&D pipeline, including the development agreement between Baxter International Inc. and Xenetic Biosciences, Inc. Such statements include expectations with regard to clinical trials, regulatory filings, the impact of new treatments to patients, and potential payments under the development agreement. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; clinical trial results; changes in laws and regulations; product quality or patient safety issues; and other risks identified in Baxter's most recent filings on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Tags: hemophilia, bleeding disorders, pharmacokinetic, polysialylated blood coagulation,
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