Healthcare Industry News: hemophilia A
News Release - July 3, 2007
Wyeth Begins Marketing and Distributing BeneFIX in EuropeCOLLEGEVILLE, Pa., July 3 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that it has assumed all marketing and distribution rights to BeneFIX® Coagulation Factor IX (Recombinant) in Europe. This transfer of responsibility follows the planned June 30, 2007 conclusion of a 10-year distribution rights agreement between Baxter Healthcare Corporation and Genetics Institute. Genetics Institute was acquired by Wyeth in 1996. Representatives of Wyeth and Baxter have worked closely together to ensure a structured transition between companies and an uninterrupted supply of BeneFIX to people with hemophilia B.
"We are pleased to broaden Wyeth's range of therapeutic offerings for the hemophilia community in Europe. We also have plans-pending European regulatory approval-to introduce new convenience enhancements to BeneFIX later this year," says Cavan Redmond, Executive Vice President & General Manager, BioPharma Business Unit at Wyeth Pharmaceuticals.
Wyeth now manufactures and markets recombinant products for both hemophilia A and B in Europe, which are rare bleeding disorders.
In May 2007, Wyeth Pharmaceuticals received a positive opinion from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, on new convenience enhancements to BeneFIX. The product enhancements are: a 2000 IU dosage strength vial, a needleless reconstitution device, a prefilled diluent syringe and a low 5 mL diluent volume for all dosage strengths.
Hemophilia B is a rare, inherited blood clotting disorder. People with hemophilia B are deficient in a key protein- factor IX- which is vital in the clotting mechanism to prevent bleeding. Hemophilia B is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia B are dependent on protein replacement therapy with factor IX.
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.
BeneFIX is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X) nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver- dependent coagulation factors.
Important Safety Information
-- As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting or tiredness.
-- BeneFIX may be contraindicated in patients with a known history of hypersensitivity to hamster protein.
-- Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.
ReFacto® Antihemophilic Factor (Recombinant) 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
-- 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 Prescribing Information for BeneFIX and ReFacto at www.hemophiliavillage.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
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