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Wyeth Pharmaceuticals Introduces the First 2000 IU Vial of ReFacto® for Hemophilia Treatment Larger Vial Size Provides Greater Convenience
St. Davids, Pa. (October 11, 2002) -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE),
announced today the introduction of a 2000 IU vial for ReFacto® Antihemophilic
Factor (Recombinant), the company's recombinant factor VIII product for the
treatment of hemophilia A.
With the introduction of the 2000 IU (International
Units) vial, Wyeth becomes the first manufacturer to introduce product in this
vial size. The new vial contains more ReFacto with the same small volume (4 mL)
of reconstitution.
"Since the introduction of ReFacto, we've received requests
from the community for a larger vial size. The availability of the new vial size
should translate to greater dosing convenience for individuals using ReFacto,"
says Victoria Kusiak, Vice President, Global Medical Affairs and North American
Medical Director, Wyeth Pharmaceuticals.
Currently, ReFacto is available in four
vial sizes: 250 IU, 500 IU, 1000 IU and now, 2000 IU. Many individuals require
infusions of greater than 2000 IU per dose, which necessitates that they use a
variety of vials to create their dosage. With the availability of a larger size,
these patients will be able to use fewer vials, allowing for easier, faster
administration. In addition, the larger vial size is expected to be useful in
the surgical setting, which often requires higher doses of antihemophilic factor.
Hemophilia is a rare, inherited blood clotting disorder for which there
currently is no cure. People with hemophilia are deficient in the key proteins
that are vital in the clotting cascade to prevent bleeding -- factor VIII
(hemophilia A) or factor IX (hemophilia B). Both forms of hemophilia are
characterized by spontaneous hemorrhages or prolonged bleeding, typically into
joints and soft tissue. In the United States, nearly 4,000 people have
hemophilia B and between 15,000 and 17,000 people have hemophilia A.
ReFacto is a recombinant factor VIII product formulated without the addition of human serum
albumin in its final formulation. ReFacto is indicated for the control and
prevention of hemorrhagic episodes and for surgical prophylaxis in hemophilia A
patients and for short-term routine prophylaxis to reduce the frequency of
spontaneous bleeding episodes. The effect of regular routine prophylaxis on
long-term morbidity and mortality is unknown. As with the intravenous
administration of any protein product, adverse reactions may include headache,
fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of
allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins.
The Chinese hamster ovary cell line used to produce ReFacto is grown in culture medium that contains human serum albumin; no
albumin is added during purification or in final formulation. Following purification, the albumin concentration is below the detection limit of the
assay. For more information, call the Hemophilia Hotline at 1-888-999-2349 or visit www.hemophiliavillage.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines.
Wyeth is one of the world's largest research-driven pharmaceutical and health care
products companies. It is a leader in the discovery, development, manufacturing,
and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people
worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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