Healthcare Industry News: hemophilia A
News Release - September 8, 2008
New Recombinant XYNTHA Now Available for Patients with Hemophilia ACOLLEGEVILLE, Pa., Sept. 8 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that product shipments have begun for XYNTHA(TM) Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, a new recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A, a rare, inherited blood-clotting disorder.
XYNTHA is produced using state-of-the-art manufacturing and purification processes designed to reduce the risk of viral contamination. The manufacturing process for XYNTHA is completely albumin-free from start to finish, while the purification process utilizes a unique synthetic ligand totally free of animal materials and a nanofiltration step using a 35 nanometer pore-size filter.
"We believe the state-of-the-art manufacturing and purification processes used for XYNTHA make it an exciting new therapeutic option for many patients with hemophilia A," says Robert Repella, Executive Vice-President and General Manager, Wyeth BioPharma. "The introduction of XYNTHA is the culmination of many years of research and development, and demonstrates Wyeth's continued commitment to the hemophilia community." As an added convenience for patients, Wyeth's one-of-a-kind Rapid Reconstitution (R2) Kit is provided with XYNTHA. The R2 Kit is designed to help patients save time by allowing for ease of transportation and fewer steps during rapid reconstitution.
Shipments of the Company's current recombinant factor VIII product, ReFactoŽ Antihemophilic Factor (Recombinant) in the United States will be discontinued as of May 31, 2009. Wyeth anticipates that many patients using ReFacto may want to talk to their health care provider about XYNTHA.
Wyeth Hemophilia Patient Access Programs
Wyeth works to help patients with hemophilia have ongoing access to their hemophilia therapies. Through its Factor Resource Program, Wyeth provides several services to assist patients experiencing financial hardship or treatment access issues, including the Insurance-Coverage Program, the Patient Assistance Program, and the Wyeth Hemophilia Hotline (1-888-999-2349).
About hemophilia A
hemophilia A is a rare, inherited blood-clotting disorder 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.
Indication for XYNTHA
XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in Von Willebrand's disease.
Important Safety Information for XYNTHA
-- Anaphylaxis and severe hypersensitivity reactions are possible. Patients should be informed of the early signs of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, hypotension] and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician if these symptoms occur.
-- Patients should be advised to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
-- The most common adverse reaction in study 1 is headache (24% of subjects) and in study 2 is fever (41% of subjects). The most common adverse reactions (greater than or equal to 5% of subjects) in clinical studies were headache, fever, nausea, diarrhea, vomiting, and weakness.
-- Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA.
-- Female patients should be advised to notify their physician if they become pregnant, intend to become pregnant, or are breastfeeding during therapy.
-- Before traveling, patients using XYNTHA should be advised to consult with their health care professional and to bring an adequate supply of XYNTHA for anticipated treatment.
Indication for ReFacto
ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
Important Safety Information for ReFacto
-- As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions.
-- The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto.
-- Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.
Please see full Prescribing Information for XYNTHA and ReFacto 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 nutritionals 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. For additional information about the company, please visit http://www.wyeth.com.
The statements in this press release that are not historical facts are forward-looking statements that 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, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and 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; emerging data on our products and pipeline 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" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. 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
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