Baxter Presents Phase I/III Data Evaluating Safety and Efficacy of BAX 326, an Investigational Recombinant Factor IX for

  Baxter Presents Phase I/III Data Evaluating Safety and Efficacy of BAX 326,
  an Investigational Recombinant Factor IX for Hemophilia B, Showing More Than
  40 Percent of Patients Experienced No Bleeds

 BAX 326 Granted Orphan-drug Designation by U.S. Food and Drug Administration

Business Wire

DEERFIELD, Ill. -- December 10, 2012

Baxter International Inc. (NYSE:BAX) today announced pivotal Phase I/III study
results evaluating the safety and efficacy of BAX 326, an investigational
recombinant factor IX (rFIX) protein, for the treatment and prophylaxis of
bleeding episodes for patients with hemophilia B over 12 years of age. The
data were presented at the 54^th Annual Meeting and Exposition of the American
Society of Hematology (ASH) in Atlanta. BAX 326 was recently granted
orphan-drug designation by the U.S. Food and Drug Administration (FDA), a
special status given to a product that when approved, will address an unmet
need for people with a rare disease or condition. Data supporting the
prophylaxis indication, which is the basis for the orphan drug designation,
was included in the biologics license application (BLA).

''With only one recombinant protein currently available to treat hemophilia B,
it was important to focus research efforts on finding another option for
patients with this debilitating disease,'' said lead investigator Jerzy
Windyga, MD, PhD, Institute of Hematology and Blood Transfusion, Warsaw,
Poland. ''In this study, more than 40 percent of patients using BAX 326 as a
prophylactic treatment experienced no bleeds, an important finding given the
potentially harmful impact of bleeding episodes for patients.''

The Phase I/III prospective, controlled, multicenter study investigated the
pharmacokinetics, efficacy and safety of BAX 326 in 73 previously-treated
patients with severe or moderately severe hemophilia B. Results from the study
showed that twice-weekly prophylactic treatment with BAX 326 achieved a median
annualized bleed rate of 1.99 with 43 percent of patients experiencing no
bleeds. The impact of prophylaxis with BAX 326 also translated into
statistically significant improvements in physical health-related quality of
life (HRQoL), as measured by improvements in the Bodily Pain and Role-Physical
domains in the Short Form Health Survey (SF-36v2) tool. Statistically
significant changes were not seen in the other physical health-related domains
or the mental health domains.

No inhibitors were detected and no cases of anaphylaxis were reported in any
patients. Three treatment-related adverse events were reported in 2 of the 73
(2.7%) patients, all of which were mild and transient: dysgeusia (distortion
of the sense of taste) occurred twice in one patient and pain in extremity
occurred once in another patient. More than 70 percent of subjects (56 of 73)
had 50 or more exposure days to BAX 326 during the study.

''As a company committed to advancing care for people with hemophilia for more
than 60 years, Baxter continues to deliver significant innovation in the field
of hemophilia. If it is approved, BAX 326 will expand treatment options for
patients,'' said Prof. Harmut J. Ehrlich, M.D., vice president of global
research and development in Baxter’s BioScience business.

To continue on its path of innovation, earlier this year Baxter announced a
partnership with Chatham Therapeutics, LLC to develop a gene therapy-based
treatment for hemophilia B. Gene therapy represents another important area of
research that may become the future of hemophilia B treatment.

About Hemophilia B

Hemophilia B is the second most common typeof hemophilia (also known as
Christmas disease) and is the result of insufficient amounts of clotting
factor IX, a naturally occurring protein in blood that controls bleeding.^1
Approximately 25,000 people worldwide, including more than 4,000 in the U.S.,
have been diagnosed with hemophilia B. ^ 2 Hemophilia B is often a
debilitating, chronic disease with complications that include bleeding
episodes, hemophilic arthropathy (bleeding into a joint) and

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 is focused on optimizing hemophilia care and
improving the lives of people living with hemophilia A and B worldwide.

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 BAX 326, an
investigational recombinant factor IX (rFIX) protein, as well as Baxter’s
partnership with Chatham Therapeutics, LLC to develop a gene therapy-based
treatment for hemophilia B. 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; additional clinical results;
changes in laws and regulations; product quality or patient safety issues; and
other risks identified in Baxter's most recent filing 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.

^1 Frequently Asked Questions About Hemophilia.World Federation of
Hemophilia.Accessed on November 28, 2012. Available at:

^2 World Federation of Hemophilia Report on the Annual Global Survey 2010.
World Federation of Hemophilia. Accessed on November 28, 2012. Available at:

^3 Lee, C. A. (2011) Hemophilia Care in the Modern World, in Current and
Future Issues in Hemophilia Care (eds E.-C. Rodríguez-Merchán and L. A.
Valentino), Wiley-Blackwell, Oxford, UK. Chapter 29. Accessed on November 28,


Baxter International Inc.
Media Contacts:
Brian Kyhos, (224) 948-4210
Deborah Spak, (224) 948-2349
Investor Contacts:
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
Press spacebar to pause and continue. Press esc to stop.