AHP's
hemophilia product portfolio uses advanced
biotechnology
tools to discover and develop safer
and
more effective treatments.
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For
approximately two decades, AHP has been a global scientific leader in
the search for safer and more effective treatments for hemophilia. As
a result of this commitment and a significant investment in recombinant
DNA technology, our efforts have led to important medical advances in
the treatment of hemophilia: the development of the first recombinant
factor IX product (BeneFIX for hemophilia B) and the first albumin-free
formulated factor VIII product (ReFacto for hemophilia A).
The original hemophilia treatments developed in the 1960s and 1970s were
derived from purified human blood plasma, which resulted in widespread
transmission of viral pathogens. Despite major improvements in purity
and viral safety, today's plasma-derived products still give rise to patient
concern about the potential for blood-borne diseases. AHP's hemophilia
product portfolio employs a theoretically safer approach using advanced
biotechnology tools to produce clotting factors from non-human production
cells.
The anchor products of our Hemophilia franchise are BeneFIX and
ReFacto. BeneFIX, the only recombinant factor IX product,
represents the state of the art in hemophilia B treatment because it is
not derived from human plasma. BeneFIX was launched in the United
States in 1997 and in Europe in 1999. It now is the number one selling
hemophilia B product in the world, with sales increasing by 18 percent
in 2000. BeneFIX continued to expand through commercialization
in several new markets during this past year, and commercial launches
are scheduled in additional countries during 2001.
ReFacto, the first recombinant factor VIII product without human serum
albumin added to the final formulation, further reduces the theoretical
risk of viral contamination for hemophilia A patients. ReFacto
was launched throughout Europe during 1999, and sales surpassed $90 million
during its first full year on the market. The FDA approved ReFacto in
March 2000, and the product was launched in the United States in January
2001. AHP plans to invest approximately $100 million in a manufacturing
facility in St. Louis, Missouri, to meet the growing demand for ReFacto.
Our research into hemophilia treatments continues to focus on increased
patient safety and efficacy. During 2001, we are scheduled to begin clinical
trials on an improvement to our existing ReFacto product. This
improved version of ReFacto will be produced without any animal-
or human-derived proteins throughout the entire manufacturing process.
In addition to our focus on improving existing treatments, we formed an
alliance during 2000 with Targeted Genetics Corporation to pursue gene
therapy treatments for hemophilia A and B that eventually may offer a
cure for these diseases.
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