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Baxter Marks World Hemophilia Day by Reaffirming Ongoing Commitment to Partnering with Community to Raise Standard of Hemophilia Care Around the World

Wed, 04/21/2010 - 1:22pm
Baxter Healthcare

DEERFIELD, Ill., April 14, 2010 – In observance of World Hemophilia Day, Baxter International Inc. today reaffirmed its ongoing commitment to optimizing hemophilia care and improving the lives of people with hemophilia worldwide. With proper care and treatment, people with bleeding disorders can live longer, more fulfilling lives than ever before, but tragically, 75 percent of people with bleeding disorders do not receive adequate treatment, and significant disparities in care exist between developed and developing countries.1, 2 To help address these disparities, Baxter, in its continued work with the World Federation of Hemophilia (WFH), today made available “The Many Faces of Bleeding Disorders – United to Achieve Treatment for All” educational video podcast (available at www.wfh.org/whd) and reaffirmed its support for WFH and humanitarian aid partner, AmeriCares, to provide therapies for people living with hemophilia who are most in need.

“Baxter is committed to advocating for the highest standards and improved access to hemophilia care, to providing safe therapies and to ensuring a consistent supply of product to patients around the world,” said Bruce Ewenstein, M.D., Ph.D., vice president, Clinical Affairs in Baxter’s BioScience business. “In developed countries with a high standard of hemophilia care and access to recombinant factor VIII therapies, such as ADVATE, the focus has largely shifted to the optimization of care for the individual – a better understanding of hemophilia-related disease processes, improvement in treatment paradigms and the development of new therapies.”

Supporting access through community participation

To help raise the standard of care and provide access to treatment for the global hemophilia community, Baxter makes available a number of resources, including education, advocacy programs and support, and clinician support.

“The Many Faces of Bleeding Disorders – United to Achieve Treatment for All” video podcast was created to raise awareness of the impact of bleeding disorders, including hemophilia, symptomatic carriers of hemophilia, von Willebrand disease, rare factor deficiencies and inherited platelet disorders, and call attention to disparities in care. The podcast is available at www.wfh.org/whd in English, as well as English with Spanish and French subtitles. An audio-only version is also available.

“The global community has made significant progress for people with hemophilia, and we need to work at research and development in some of the lesser known bleeding disorders to achieve an optimal level of care so that we can truly offer treatment for all,” said Mark Skinner, president, World Federation of Hemophilia. “We are grateful to Baxter for its support of ‘The Many Faces of Bleeding Disorders’ video podcast because it highlights an important factor in that continued progress – a concerted effort by the research, medical, advocacy and patient communities is needed to ensure broad-based access to care and treatment.”

Baxter continues to support a multi-year commitment to WFH’s Global Alliance for Progress (GAP) program as the founding and leading sponsor, and other Baxter programs such as a compassionate use program in China, one of the newest GAP countries. Through these programs, in addition to an ongoing relationship with humanitarian aid partner AmeriCares, Baxter has reached those living with hemophilia in underserved countries with over 10 million international units of much needed factor replacement therapy donations over the past several years. Looking forward, Baxter remains committed to the WFH GAP program, pledging further donations for 2010 and beyond and will continue to support AmeriCares in responding to those in need.

“In China, less than 10 percent of the hemophilia population has been registered, resulting in a difficult situation where patients and doctors cannot find each other, and patients do not have access to proper diagnosis,” said Ruan Changgeng, M.D., professor, Soochow University Medical College; director, Jiangsu Institute of Hematology; and president, Chinese Society of Hematology. “The goals of the GAP program in China are to improve care offered at hemophilia treatment centers, increase donation of factor VIII to China, strengthen the patient advocacy organizations and their communications with the government, and improve the registration system, and a concerted effort by the community has enabled us to make excellent progress to date.”

Baxter also supports the education and training of healthcare professionals who treat bleeding disorders through the U.S. National Hemophilia Foundation-Baxter Clinical Fellowship Program in Bleeding Disorders Research, among other programs.

Advancing new treatments that may improve patient outcomes

Baxter continues to invest in the future of bleeding disorder care by applying its breadth and depth of hemophilia expertise to develop new therapies to treat hemophilia A and B, patients with inhibitors and von Willebrand disease (VWD). A Phase I clinical study is underway to evaluate the pharmacokinetics, safety and tolerability of recombinant von Willebrand factor (rVWF) in Type 3 VWD patients. Earlier this year, Baxter initiated a Phase I dose finding study for an oral non-anticoagulant sulfated polysaccharide (NASP) with a novel pathway to determine if it has utility as adjunctive therapy in the prevention of bleeding episodes and enhancement of clotting function in hemophilia patients, including those with inhibitors. Additionally, a preclinical program is exploring multiple approaches in the development of a longer-acting FVIII molecule.

Ensuring patient access to appropriate therapies

Baxter has a history of providing a reliable and consistent supply of hemophilia therapy, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a full-length recombinant factor VIII (rFVIII) therapy that is free of blood-based additives. More than 7 billion units of ADVATE have been distributed since its initial approval more than six years ago, making it the number-one chosen hemophilia therapy worldwide.

Baxter understands that the needs of the global hemophilia community are rising due to the expanded geographic demand for recombinant factor VIII (rFVIII) therapies, improving standards of care in developing countries, increased prophylactic use of FVIII therapies (for therapies approved for prophylaxis) and the changing profile of hemophilia patients, whose life expectancy has increased dramatically. The company is committed to meeting these current and changing future needs of the global hemophilia community.

About World Hemophilia Day

World Hemophilia Day occurs each year on April 17. Since its creation in 1989 in honor of the World Federation of Hemophilia’s founder Frank Schnabel, World Hemophilia Day has served as an opportunity to increase awareness of hemophilia and other bleeding disorders and their impact on the global community.

About Hemophilia

Hemophilia is a rare genetic blood clotting disorder that primarily affects males.1 People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.1 Two of the most common forms of hemophilia are A and B.1 In people with hemophilia A, clotting FVIII is not present in sufficient amounts or is absent.1 Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.1 People with hemophilia B (also called Christmas disease) do not have sufficient amounts of clotting factor IX.1 In about 30 percent of cases, there is no family history of hemophilia and the condition is the result of a spontaneous gene mutation.1 According to the World Federation of Hemophilia, more than 400,000 people in the world have hemophilia.2 All races and economic groups are affected equally.2

About VWD3

VWD is the most common type of bleeding disorder and affects both men and women. Patients with VWD either produce insufficient VWF or carry defective VWF and may experience problems with forming clots to stop bleeding. It is estimated that up to one percent of the world’s population suffers from VWD, but because many people have only mild symptoms, only a small number of them may know they have it. Research has suggested that as many as nine out of 10 people with VWD have not been diagnosed.

There are three major subtypes of VWD. Type 3 VWD is usually the most severe form as patients have very little or no VWF. Patients with Type 3 VWD experience primarily mucosal bleeds, such as nosebleeds, and in women, severe menstrual bleeding, but can also suffer from bleeding into muscles and joints.

Important Risk Information for ADVATE Therapy

ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product.

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesia, rash, flushing, face swelling, urticaria, dyspnea, and pruritis. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Patients treated with AHF products should be monitored for the development of factor VIII inhibitors. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).

If expected plasma factor VIII levels are not attained, or if bleeding is not controlled with an expected dose, test for the presence of inhibitors.

The most serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions observed in clinical trials (frequency

≥2% of subjects) were factor VIII inhibitor formation (observed predominantly in PUPs) and headache.

Please see full prescribing information at www.advate.com.

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, 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.

References

1 Frequently Asked Questions About Hemophilia. World Federation of Hemophilia. Accessed on: 18 February 2010. Available at: http://www.wfh.org/2/1/1_1_1_FAQ.htm.

2 What is Hemophilia? World Federation of Hemophilia. Accessed on: 18 February 2010. Available at: www.wfh.org/2/1/1_1_Hemophilia.htm.

3 What is Von Willebrand Disease? World Federation of Hemophilia. Accessed on: 1 March 2010. Available at: http://www.wfh.org/2/1/1_2_VWD_What-is-VWD.htm.

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