|
BAXTER
FILES MARKETING AUTHORIZATION APPLICATION TO EMEA FOR FIRST PLASMA/ALBUMIN
FREE METHOD RECOMBINANT FACTOR VIII HEMOPHILIA THERAPY
DEERFIELD, Ill., September,
26, 2002 -- Baxter International Inc. announced today that a Marketing
Authorization Application (MAA) has been submitted to the European Medicines
Evaluation Agency: Committee for Proprietary Medicinal Products for Antihemophilic
Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment
of hemophilia A. The submission has been made through the European Union
(EU) Centralized Procedure. The MAA filing is the first step in gaining
regulatory approval in the 15-member states of the EU, plus Norway and
Iceland.
The MAA submission is based on results from a global, multi-center, randomized,
double-blind, cross-over study comparing rAHF-PFM and Recombinate recombinant
antihemophilic factor (rAHF). Recombinate, a recombinant Factor VIII therapy,
has been available from Baxter since 1992.
During the last 40 years, Baxter has continually been first to provide
the hemophilia community with enhanced Factor VIII products. rAHF-PFM
is Baxter's latest technological advancement and is the first Factor VIII
recombinant therapy to be clinically developed and prepared without the
addition of any human- or animal-derived raw materials in the cell culture
process, purification or final formulation.
All currently available recombinant Factor VIII therapies use human- or
animal-derived raw materials at some point in their production processes
or final product formulations. While these therapies have substantially
reduced the potential for transmission of viruses, concerns remain within
the medical and hemophilia communities about the possible transmission
of currently known and unknown viruses or diseases through the continued
use of human- or animal-derived additives in hemophilia therapy.
Baxter submitted a Biologics License Application to the U.S. Food and
Drug Administration (FDA) on June 27, 2002 for rAHF-PFM, which also seeks
licensure of one manufacturing suite in its state-of-the-art, multi-purpose
facility in Neuchâtel, Switzerland. The U.S. FDA formally accepted
the file for review in August. Baxter's MAA filing also seeks licensure
of two manufacturing suites at the Neuchâtel facility.
Hemophilia A is caused by the absence or severe deficiency of Factor VIII,
a protein in human blood critical for proper blood coagulation. People
with hemophilia A experience spontaneous, internal bleeding associated
with pain, chronic joint destruction and, if left untreated, may become
life-threatening. However, barring other complications or disorders, clinicians
today expect the life expectancy of patients to be near normal, provided
they receive proper treatment and care.
Baxter International Inc. (NYSE: BAX) is a global health care company
that, through its subsidiaries, provides critical therapies for people
with life-threatening conditions. Baxter's bioscience, medication delivery
and renal products and services are used to treat patients with some of
the most challenging medical conditions including cancer, hemophilia,
immune deficiencies, infectious diseases, kidney disease and trauma.
(Baxter and Recombinate are trademarks of Baxter International Inc.)
FOR ADDITIONAL
INFORMATION:
 |
- Media Contacts:
- Deborah Spak,
847-948-2349
Patricia O'Hayer 011 2 650 1924
- Investor Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
-
|
| |
|