BUENOS AIRES, ARGENTINA, July 9 – Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia (WFH) 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia. These presentations follow Pfizer's recent announcement about the creation of a new research unit focused on rare diseases, including hemophilia.
"We are very excited to present these data, which highlights the strength of our pipeline and our enduring commitment to provide recombinant products for the hemophilia community," says Brenda Cooperstone, M.D., vice president of clinical development and medical affairs for the Specialty Care Business Unit at Pfizer. "Our investigation of novel therapies for hemophilia treatment remains ongoing and we will continue to work closely with our partners—including the World Federation of Hemophilia—to help improve hemophilia care worldwide."
Early Research with Factor Xa and VIIa
Pfizer will present the results of a pre-clinical study in mice indicating that recombinant factor Xa therapy may provide a unique way to bypass deficiencies in the intrinsic pathway. Additional results from a preclinical study in mice suggest that a recombinant factor VIIa molecule with increased activity and duration of action may have the potential to improve inhibitor outcomes.
Additional Hemophilia Research from Pfizer at WFH
- New model of antibody-induced hemophilia A for the assessment of bypass therapies
- An electronic documentation system in Haemophilia provides otherwise unavailable feedback for continuous quality control – first results from the Haemoassist® system
- A prospective registry of European hemophilia B patients receiving BeneFIX® (nonacog alfa, recombinant human factor IX) for usual use
- Two-year interim results of a non-interventional trial to assess the safety and efficacy of treatment with recombinant factor IX
- Safety and efficacy of B-domain-deleted recombinant FVIII – final results of a 10 year pharmacovigilance study
Pfizer's Ongoing Commitment to the WFH and the Hemophilia Community
Pfizer will make a contribution to WFH at the meeting in support of the Twinning Program, which aims to increase the level of diagnosis and care for people with hemophilia by pairing emerging treatment centers and patient organizations with more established centers and organizations around the world. Wyeth, now part of Pfizer, has acted as the exclusive corporate sponsor of the world-renowned program since 2001, which currently has 32 Twinning partnerships worldwide. Historically, there have been 149 Twinnings. Pfizer will also host the annual reception for the Twinning Program.
Hemophilia is a rare, inherited blood-clotting disorder characterized by spontaneous hemorrhages or prolonged bleeding. People with hemophilia are deficient in one of the key proteins – factor VIII for hemophilia A or factor IX for hemophilia B – that is needed for normal blood clotting. Most patients with hemophilia are dependent on replacement therapy.
Indication for BeneFIX
BeneFIX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management.
BeneFIX is NOT indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors.
Important Safety Information for BeneFIX
- BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
- Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought.
- BeneFIX has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFIX administration by continuous infusion have not been established.
- Development of activity-neutralizing antibodies has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.
- Patients may develop hypersensitivity to hamster (CHO) protein as BeneFIX contains trace amounts.
- The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.
Please see full Prescribing Information for BeneFIX available at www.pfizer.com.
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 ReFacto available at www.pfizer.com.
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PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 9, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information regarding the Pfizer Hemophilia Franchise.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.