New recombinant XYNTHA(TM) now available for patients with hemophilia A

TORONTO , Dec. 1 /CNW/ - Canadians with hemophilia A - a rare, inherited blood-clotting disorder - now have a new treatment option with the introduction of XYNTHA(TM), a recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis(1).

XYNTHA, developed by Wyeth Pharmaceuticals, now a Pfizer company, is produced using state-of-the-art manufacturing and purification processes designed to reduce the risk of viral contamination. It employs true "next-generation" technology, with completely albumin-free manufacturing from start to finish, purification that is completely free of animal-derived materials, and a virus-capturing nanofiltration step(2).

"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says François Therrien, Director, Medical Affairs, Specialty Care Business Unit, Pfizer Canada Inc. "XYNTHA provides the highest level of pathogen safety available - patients can trust that every measure is being employed to ensure their safety."

Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists(3).

The nanofiltration step is an additional safety measure that is unique to XYNTHA. It employs a 35 nanometer pore-size filter that is designed to enhance the viral safety profile and provide added assurance to the hemophilia A community(4).

"We believe the state-of-the-art manufacturing and purification processes used for XYNTHA make it an exciting new therapeutic option for many Canadians with hemophilia A," says Therrien. "It's the culmination of many years of research and development, and demonstrates our continued commitment to the hemophilia community."

Hemophilia A is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. People with hemophilia A are deficient in a key protein - factor VIII - that is vital in the clotting mechanism to prevent bleeding. Most patients with hemophilia A are dependent on factor VIII replacement therapy(5).

    
    Safety and efficacy demonstrated in clinical trials
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The safety and efficacy of XYNTHA in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with hemophilia A has been demonstrated in pivotal clinical trials. The trials looked at previously treated patients who have severe or moderately severe hemophilia A and found that 92.5 per cent of bleeds were treated successfully with 1 or 2 infusions (study included 53 patients) and subjects rated first infusion outcomes as excellent or good (70.6 per cent)(6).

The most common adverse events reported in clinical trials included headache and fever(7).

    
    Added convenience for patients
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XYNTHA is available in four (4) vial sizes, 250IU / 500IU / 1000IU /, and the 2000 IU vial. It is packaged with a one-of-a-kind Rapid Reconstitution (R2) Kit allowing for greater safety, ease of transportation, and fewer steps during rapid reconstitution(8).

    
    About hemophilia A in Canada
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Hemophilia A is a rare, inherited blood clotting disorder that affects approximately 1 in 10,000 Canadians, primarily males(9). Caused by a mutation of the Factor VIII gene, hemophilia A leads to a deficiency in Factor VIII, which is essential to blood clotting.

In Canada , there are comprehensive care clinics across the country that provide medical services needed by persons with bleeding disorders and their families. The comprehensive care team consists of a hematologist, nurse coordinator, physiotherapist and social worker with specific expertise in managing the healthcare needs of persons with bleeding disorders.

Pfizer is committed to the advancement of science in the treatment of hemophilia and is now the only manufacturer offering recombinant treatment solutions for both Hemophilia A and B with XYNTHA and BeneFIX(TM) - Nonacog alfa (Recombinant Coagulation Factor IX).

    
    About Pfizer in Canada
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Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. The company is one of the largest contributors to health research in Canada . Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer Canada employees work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything Pfizer does, from our disease awareness initiatives to our community partnerships, to our belief that it takes more than medication to be truly healthy. To learn more about Pfizer's More than Medication philosophy and programs, visit morethanmedication.ca. To learn more about Pfizer Canada , visit www.pfizer.ca.

Wyeth is now a part of Pfizer Inc. The merger of local Wyeth and Pfizer entities may be pending in various jurisdictions and is subject to completion of various local legal and regulatory obligations.

    
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    (1) XYNTHA Product monograph, April 23, 2008, page 3
    (2) XYNTHA Product monograph, April 23, 2008, page 23
    (3) XYNTHA Prescribing information, page 11
    (4) XYNTHA Product monograph, April 23, 2008, page 23
    (5) U.S. Department of Health and Human Services. http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_what.html.
    Accessed February 5, 2009.
    (6) XYNTHA Product monograph, April 23, 2008, page 24
    (7) XYNTHA Prescribing Information, page 1
    (8) XYNTHA Product monograph, page 2
    (9) Canadian Hemophilia Society. http://www.hemophilia.ca/en/faq/.
        Accessed February 5, 2009.
    

For further information: Lisa Ross, Wyeth, a Pfizer Company, [phone], [email protected]; Pfizer Media Relations, 1-866-9Pfizer (1-866-973-4937); Jennifer Dolan, Edelman, [phone] ext. 257, [email protected]