Maidenhead, England (ots/PRNewswire)
- Improvements in Purification Process Represent Important
Advance in the Treatment of Haemophilia A
Wyeth announced today it has received a positive decision from
the European Commission for a variation of the marketing
authorisation for ReFacto moroctocog alfa (Recombinant Coagulation
Factor VIII), a treatment for haemophilia A. The manufacturing
process for ReFacto has been modified, and the name has been changed
to ReFacto AF moroctocog alfa (Recombinant Coagulation Factor VIII).
The decision by the European Commission follows a positive
recommendation from the Committee for Medicinal Products for Human
Use on 18 December 2008.
ReFacto AF - indicated for the treatment and prophylaxis of
bleeding in adults and children of all ages with haemophilia A - is a
recombinant factor VIII product free of added exogenous human- or
animal-derived protein in its cell culture, manufacturing,
purification processes and final formulation.
"This milestone is an important step in the evolution of
haemophilia A treatment and establishes a new standard in recombinant
factor VIII product purification," says Andreas Krebs, President,
Wyeth Europe. "We believe the state-of-the-art manufacturing and
purification process used for ReFacto AF make it an exciting new
therapeutic option for many patients with Haemophilia A."
Wyeth is planning to make ReFacto AF available in the European
Union (EU), where the predecessor product ReFacto is currently
commercially available, in June 2009. The product will be launched in
most EU member countries at the same time to ensure that haemophilia
A patients have access to the therapy as soon as possible. Once
ReFacto AF is introduced, Wyeth will no longer supply ReFacto. The
company will work with health care professionals, haemophilia
treatment centres and home health care companies to help them manage
their supply while transitioning from ReFacto to ReFacto AF.
Improvements in Purification Technology
Until now, the purification process for all recombinant factor
VIII products used monoclonal antibodies derived from mouse cell
lines. ReFacto AF is completely albumin-free, uses a synthetic
peptide ligand that is totally free of animal materials and includes
a viral-retaining nanofiltration purification step to further reduce
the risk of potential viral contamination.
"Reducing the risk of transmitted infection is a major
consideration. ReFacto AF was developed in response to the
community's desire to completely remove albumin as a theoretical
source of pathogen transmission. We believe that by having access to
a product which in its production process is both free of exogenous
animal or human-derived proteins and relies on a sophisticated
purification process will give both health care providers and
patients 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, which
affected approximately 30,000 people in the European Union in 2005.
People with haemophilia A are deficient in a key protein - factor
VIII - which is vital in the clotting mechanism to prevent bleeding.
This condition can be characterized by spontaneous haemorrhages or
prolonged bleeding, typically into joints and soft tissue. Most
patients with haemophilia A are dependent on factor VIII replacement
Wyeth and Haemophilia
Wyeth is a leader in hemophilia science, having developed the
first and only albumin-free recombinant factor IX therapy for the
treatment of haemophilia B, and continues to research new recombinant
products for the treatment of bleeding disorders. With the
introduction of ReFacto AF, Wyeth is the only company to offer
state-of-the-art recombinant factor VIII and IX therapies for the
treatment of haemophilia A and B, respectively. Wyeth also works to
help improve the health of haemophilia patients through education,
patient assistance programs, and by supporting associations such as
the World Federation of Haemophilia, the European Association for
Haemophilia and Allied Disorders, and the European Haemophilia
Wyeth is one of the world's largest research-based pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines,
biotechnology and animal health care.
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ots Originaltext: Wyeth Pharmaceuticals
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; Danielle Halstrom,
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