Grifols, a global healthcare and pharmaceutical company headquartered in Barcelona,
Spain, announced that it will open a new facility to produce blood derivatives to increase
its plasma manufacturing capacity. The announcement was made on March 13, 2007 at a
meeting in Los Angeles. The company projects that the “MiniFrac” facility will increase
its plasma output by up to 700,000 liters, expanding its capacity to produce products to
treat hemophilia and other bleeding disorders.
The manufacturing facility was acquired by Grifols in July 2003 as part of a deal with
Alpha Therapeutics. Although Alpha Therapeutics completed construction of the facility
in 1999, it did not receive approval from the U.S. Food and Drug Administration (FDA)
and did not become a working plant. Grifols estimates that validation and FDA approval
will take approximately two years.
“With growing demand for our life-saving therapies in the U.S. and around the world, we
are now in a position to begin increasing our plasma fractionation capacity,” said Victor
Grifols, president and CEO. “This additional capacity will result in 2.2 million liters in
the US and 2.1 million liters in Spain, for total of 4.3 million liters of combined
fractionation capacity for our two facilities.”
Grifols manufactures several products to treat patients with bleeding disorders.
Alphanate® is a plasma-derived factor VIII/von Willebrand factor product for preventing
and controlling bleeding in patients with hemophilia A or acquired factor VIII deficiency.
In February 2007, the FDA approved Alphanate® to treat specific patients with von
Willebrand disease (VWD) undergoing surgery or invasive procedures or in whom the
synthetic hormone desmopressin is either ineffective or contraindicated. However, it is
not approved for type 3 severe VWD patients undergoing major surgery.
Grifols also produces AlphaNine®, a plasma-derived factor concentrate that prevents and
controls bleeding in patients with hemophilia B; and Profilnine®, a plasma-derived factor
concentrate for patients with factors II, VII or X deficiency.
Source: Grifols news release dated March 13, 2007