Wyeth Begins Marketing and Distributing BeneFIX in Europe
Collegeville, Pennsylvania (ots/PRNewswire) -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announcedtoday that it has assumed all marketing and distribution rights toBeneFIX(R) Coagulation Factor IX (Recombinant) in Europe. Thistransfer of responsibility follows the planned June 30, 2007conclusion of a 10-year distribution rights agreement between BaxterHealthcare Corporation and Genetics Institute. Genetics Institute wasacquired by Wyeth in 1996. Representatives of Wyeth and Baxter haveworked closely together to ensure a structured transition betweencompanies and an uninterrupted supply of BeneFIX to people withhemophilia B.
"We are pleased to broaden Wyeth's range of therapeutic offeringsfor the hemophilia community in Europe. We also have plans-pendingEuropean regulatory approval-to introduce new convenienceenhancements to BeneFIX later this year," says Cavan Redmond,Executive Vice President & General Manager, BioPharma Business Unitat Wyeth Pharmaceuticals.
Wyeth now manufactures and markets recombinant products for bothhemophilia A and B in Europe, which are rare bleeding disorders.
In May 2007, Wyeth Pharmaceuticals received a positive opinionfrom the Committee for Medicinal Products for Human Use, thescientific committee of the European Medicines Agency, on newconvenience enhancements to BeneFIX. The product enhancements are: a2000 IU dosage strength vial, a needleless reconstitution device, aprefilled diluent syringe and a low 5 mL diluent volume for alldosage strengths.
Hemophilia B is a rare, inherited blood clotting disorder. Peoplewith hemophilia B are deficient in a key protein- factor IX- which isvital in the clotting mechanism to prevent bleeding. Hemophilia B ischaracterized by spontaneous hemorrhages or prolonged bleeding,typically into joints and soft tissue. Patients with hemophilia B aredependent on protein replacement therapy with factor IX.
BeneFIX is indicated for the control and prevention of hemorrhagicepisodes in patients with hemophilia B (congenital factor IXdeficiency or Christmas disease), including control and prevention ofbleeding in surgical settings.
BeneFIX is not indicated for the treatment of other factordeficiencies (e.g., factors II, VII, VIII and X) nor the treatment ofhemophilia A patients with inhibitors to factor VIII, nor thereversal of coumarin-induced anticoagulation, nor the treatment ofbleeding 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(R) Antihemophilic Factor (Recombinant) is indicated forthe control and prevention of hemorrhagic episodes and for surgicalprophylaxis and for short-term routine prophylaxis to reduce thefrequency of spontaneous bleeding episodes in patients withhemophilia A. The effect of regular routine prophylaxis on long-termmorbidity 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 atwww.hemophiliavillage.com.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading productsin the areas of women's health care, infectious disease,gastrointestinal health, central nervous system, inflammation,transplantation, hemophilia, oncology, vaccines and nutritionalproducts. Wyeth is one of the world's largest research-drivenpharmaceutical and health care products companies. It is a leader inthe discovery, development, manufacturing and marketing ofpharmaceuticals, vaccines, biotechnology products andnon-prescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge AnimalHealth.
The statements in this press release that are not historical factsare forward-looking statements based on current expectations offuture events and are subject to risks and uncertainties that couldcause actual results to differ materially from those expressed orimplied by such statements. These risks and uncertainties include theinherent uncertainty of the timing and success of, and expenseassociated with, research, development, regulatory approval andcommercialization of our products, including with respect to ourpipeline products; government cost-containment initiatives;restrictions on third-party payments for our products; substantialcompetition in our industry, including from branded and genericproducts; data generated on our products; the importance of strongperformance from our principal products and our anticipated newproduct introductions; the highly regulated nature of our business;product liability, intellectual property and other litigation risksand environmental liabilities; uncertainty regarding our intellectualproperty rights and those of others; difficulties associated with,and regulatory compliance with respect to, manufacturing of ourproducts; risks associated with our strategic relationships; economicconditions including interest and currency exchange ratefluctuations; changes in generally accepted accounting principles;trade buying patterns; the impact of legislation and regulatorycompliance; risks and uncertainties associated with global operationsand sales; and other risks and uncertainties, including thosedetailed from time to time in our periodic reports filed with theSecurities and Exchange Commission, including our current reports onForm 8-K, quarterly reports on Form 10-Q and annual report on Form10-K, particularly the discussion under the caption "Item 1A, RiskFactors." The forward-looking statements in this press release arequalified by these risk factors. We assume no obligation to publiclyupdate any forward-looking statements, whether as a result of newinformation, future developments or otherwise.
Web site: http://www.wyeth.com http://www.hemophiliavillage.com
ots Originaltext: Wyeth PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Media Contacts, Natalie deVane of Wyeth Pharmaceuticals, +1-484-865-5139, or Douglas Petkus of Wyeth, +1-973-660-5218, or Investor, Justin Victoria of Wyeth, +1-973-660-5340
In Zusammenarbeit mit Medizinfuchs
Wyeth Begins Marketing and Distributing BeneFIX in Europe