2009-03-11

European Commission Approves ReFacto AF(TM) as a Variation to the Refacto(R) Marketing Authorisation


Maidenhead, England (ots/PRNewswire) -

- Improvements in Purification Process Represent ImportantAdvance in the Treatment of Haemophilia A

Wyeth announced today it has received a positive decision fromthe European Commission for a variation of the marketingauthorisation for ReFacto moroctocog alfa (Recombinant CoagulationFactor VIII), a treatment for haemophilia A. The manufacturingprocess for ReFacto has been modified, and the name has been changedto ReFacto AF moroctocog alfa (Recombinant Coagulation Factor VIII).The decision by the European Commission follows a positiverecommendation from the Committee for Medicinal Products for HumanUse on 18 December 2008.

ReFacto AF - indicated for the treatment and prophylaxis ofbleeding in adults and children of all ages with haemophilia A - is arecombinant factor VIII product free of added exogenous human- oranimal-derived protein in its cell culture, manufacturing,purification processes and final formulation.

"This milestone is an important step in the evolution ofhaemophilia A treatment and establishes a new standard in recombinantfactor VIII product purification," says Andreas Krebs, President,Wyeth Europe. "We believe the state-of-the-art manufacturing andpurification process used for ReFacto AF make it an exciting newtherapeutic option for many patients with Haemophilia A."

Wyeth is planning to make ReFacto AF available in the EuropeanUnion (EU), where the predecessor product ReFacto is currentlycommercially available, in June 2009. The product will be launched inmost EU member countries at the same time to ensure that haemophiliaA patients have access to the therapy as soon as possible. OnceReFacto AF is introduced, Wyeth will no longer supply ReFacto. Thecompany will work with health care professionals, haemophiliatreatment centres and home health care companies to help them managetheir supply while transitioning from ReFacto to ReFacto AF.

Improvements in Purification Technology

Until now, the purification process for all recombinant factorVIII products used monoclonal antibodies derived from mouse celllines. ReFacto AF is completely albumin-free, uses a syntheticpeptide ligand that is totally free of animal materials and includesa viral-retaining nanofiltration purification step to further reducethe risk of potential viral contamination.

"Reducing the risk of transmitted infection is a majorconsideration. ReFacto AF was developed in response to thecommunity's desire to completely remove albumin as a theoreticalsource of pathogen transmission. We believe that by having access toa product which in its production process is both free of exogenousanimal or human-derived proteins and relies on a sophisticatedpurification process will give both health care providers andpatients a greater sense of security," says Mikael Dolsten, MD, PhD,President, Wyeth Research.

About Haemophilia A

Haemophilia A is a rare, inherited blood clotting disorder, whichaffected approximately 30,000 people in the European Union in 2005.People with haemophilia A are deficient in a key protein - factorVIII - which is vital in the clotting mechanism to prevent bleeding.This condition can be characterized by spontaneous haemorrhages orprolonged bleeding, typically into joints and soft tissue. Mostpatients with haemophilia A are dependent on factor VIII replacementtherapy.

Wyeth and Haemophilia

Wyeth is a leader in hemophilia science, having developed thefirst and only albumin-free recombinant factor IX therapy for thetreatment of haemophilia B, and continues to research new recombinantproducts for the treatment of bleeding disorders. With theintroduction of ReFacto AF, Wyeth is the only company to offerstate-of-the-art recombinant factor VIII and IX therapies for thetreatment of haemophilia A and B, respectively. Wyeth also works tohelp improve the health of haemophilia patients through education,patient assistance programs, and by supporting associations such asthe World Federation of Haemophilia, the European Association forHaemophilia and Allied Disorders, and the European HaemophiliaConsortium.

ABOUT WYETH:

Wyeth is one of the world's largest research-based pharmaceuticaland health care products companies. It is a leader in the discovery,development, manufacturing, and marketing of prescription drugs andover-the-counter medications. It is also a global leader in vaccines,biotechnology and animal health care.

To access further media information relating to this pressrelease, additional information on ReFacto AF and future mediaannouncements, please register on the media centre athttp://www.wyeth.eu. If you subscribe to receive our emails you willget updates as soon as new content is added to the site. Please noteyou will be able to unsubscribe at any time and we will not pass yourdetails to any third party.

ots Originaltext: Wyeth PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information, please contact: Wyeth: Gill Markham, Communications - Europe, Middle East and Africa, Direct Tel: +44-1628-692536, Email: markhagl@wyeth.com; Danielle Halstrom, Communications - Global, Direct Tel: +1-484-865-2020, Email: halstrd@wyeth.com

Wyeth Pharmaceuticals

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European Commission Approves ReFacto AF(TM) as a Variation to the Refacto(R) Marketing Authorisation

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