COLLEGEVILLE, Pa., March 26 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for new product enhancements for BeneFIX(R) Coagulation Factor IX (Recombinant) that will offer patients a simpler and more convenient preparation process compared with the original BeneFIX preparation process. BeneFIX is a coagulation factor created using recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own.
A new BeneFIX feature allows patients currently using the most common dosage strength -- 1000 international units (IU) -- to use a lower volume of diluent to administer the product, leading to a lower total volume of infused product. BeneFIX also offers a new needleless preparation process, eliminating the risk of needlesticks during reconstitution.
“Each of these product enhancements is a first for the treatment of hemophilia B. These new features were designed to enable BeneFIX patients to spend less time preparing their factor product, to prepare it more safely and to have additional time for themselves,” says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.
The FDA approved the following four product enhancements for BeneFIX Coagulation Factor IX: a 2000 IU dosage strength vial, a needleless reconstitution device, a prefilled diluent syringe and a reduced diluent volume.
R2 Kit Offers Greater Convenience for Product Preparation
Wyeth’s needleless reconstitution kit -- the BeneFIX R2 Kit -- will offer a faster and simpler preparation process compared with the original BeneFIX preparation process, without the risk of needlesticks during reconstitution. With the R2 Kit -- R2 stands for rapid reconstitution -- the number of steps for preparing an infusion is reduced, and exposure to a needle during the reconstitution process is eliminated. The R2 Kit contains a syringe prefilled with diluent, a vial adapter and a single-use vial of BeneFIX.
Lower Diluent Volume and New Prefilled Syringe Allow Ease of Product Preparation
With the recent FDA approval, the final infusion volume for BeneFIX could be reduced by up to 75 percent for an individual patient. For some patients, a reduced diluent amount translates to less volume to infuse. This is useful for any patient but particularly those who infuse multiple vials of BeneFIX. With the introduction of the 5 mL prefilled diluent syringe for all dosage strengths, including the new 2000 IU dosage strength vial, BeneFIX will have the lowest infusion volume of hemophilia B therapies when similar IU amounts are infused.
Larger IU Vial Contributes to Easier Product Preparation
Because many individuals require infusions of greater than 2000 IU per dose, patients often are required to use several vials at a time. With the introduction of the 2000 IU dosage strength vial for BeneFIX, many patients will be able to use fewer vials of BeneFIX to achieve their desired dosage, allowing for easier and faster preparation compared with the original BeneFIX preparation process. In addition, the 2000 IU vial is expected to be useful in the surgical setting, which often requires higher doses of hemophilia treatments. The BeneFIX 2000 IU dosage strength vial will be the largest unit dosage vial offered for hemophilia B treatment.
Wyeth expects to begin offering BeneFIX with these new enhancements in mid-2007. BeneFIX is the only recombinant clotting factor product for hemophilia B and inherently is free from the risk of transmission of human blood-borne pathogens, such as HIV, hepatitis viruses and parvovirus.
The development of the new BeneFIX features is one element of Wyeth’s commitment to offering advances for hemophilia patients. Recently, the Company announced development partnerships with Nautilus Biotech in Evry, France, and MediVas, LLC, in San Diego, Calif., to develop longer-acting hemophilia therapies.
About Hemophilia
Hemophilia is a rare, inherited blood clotting disorder, and hemophilia B affects approximately 3,300 people in the United States. People with hemophilia are deficient in one of the key proteins -- either factor VIII (hemophilia A) or factor IX (hemophilia B) -- that are vital in the clotting cascade to prevent bleeding. Both forms of hemophilia are characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia A or hemophilia B are dependent on protein replacement therapy with factor VIII or factor IX, respectively.
Indication
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. Please see full Prescribing Information at http://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.
Wyeth Pharmaceuticals
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