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XYNTHA represents important improvements in product purification technology
COLLEGEVILLE, PA, USA | February 21, 2008 | Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it has received approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. XYNTHA (pronounced "ZIN-tha") is manufactured using a completely albumin-free process and state- of-the-art nanofiltration purification technology. In addition, XYNTHA is the only recombinant factor VIII product to utilize an entirely synthetic (non- human and non-animal based) purification process in its manufacture.
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.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "This is another example of Wyeth's continued commitment to the advancement of science in the treatment of hemophilia."
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.
About Hemophilia A
Hemophilia A is a rare, inherited blood-clotting disorder. People with hemophilia A are deficient in a key protein -- factor VIII -- which is vital in the clotting mechanism to prevent bleeding. Hemophilia A can be characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with hemophilia A are dependent on factor VIII replacement therapy.
Indication
XYNTHA(TM) Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.
Important Safety Information
-- Allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs or symptoms of hypersensitivity reactions (including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, and hypotension) and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physicians if these symptoms occur.
-- Inhibitors have been detected in patients receiving factor VIII- containing products. In a pivotal phase 3 study, two of 89 patients (2.2 percent) who completed greater than or equal to 50 exposure days developed factor VIII inhibitor. These results were consistent with the pre-specified endpoint of the study. Patients using coagulation factor VIII products, including XYNTHA, should be monitored for the development of factor VIII inhibitors. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
-- XYNTHA contains trace amounts of hamster proteins. Patients treated with this product could develop hypersensitivity to these nonhuman mammalian proteins.
-- When clinically indicated, patients should have plasma factor VIII activity levels monitored by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained.
-- The most frequently reported adverse reactions in clinical studies were headache and fever.
Please see XYNTHA full Prescribing Information available at www.wyeth.com.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
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.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
SOURCE: Wyeth Pharmaceuticals |
