|
BAXTER SUBMITS
FILE TO U.S. FDA FOR MARKETING APPROVAL OF PLASMA/ALBUMIN FREE METHOD
RECOMBINANT FACTOR VIII HEMOPHILIA THERAPY
DEERFIELD, ILL. JUNE
27, 2002 -- Baxter Healthcare Corporation today announced that a Biologics
License Application (BLA) has been submitted to the U.S. Food and Drug
Administration (FDA) for marketing approval of Antihemophilic Factor (Recombinant),
Plasma/Albumin Free Method (rAHF-PFM). The BLA submission is the first
step in the regulatory process for Baxter to gain U.S. licensure for rAHF-PFM
for the treatment of hemophilia A. Baxter plans to file for European regulatory
approval during the third quarter of 2002.
The regulatory submission is based on results from a global, multi-center,
randomized double-blind, cross-over study comparing rAHF-PFM and the control,
Recombinate Antihemophilic Factor (Recombinant) (rAHF).
"Submitting the file for this product is one of the most significant
milestones across Baxter this year," said Harry M. Jansen Kraemer,
Jr., Baxter's chairman and chief executive officer. "Not only is
it an important step in our effort to provide Factor VIII product needed
to meet growing demand, it reflects the innovative nature of our pipeline
and the steady flow of products we hope to bring to market over the next
few years."
Baxter Healthcare Corporation is the principal domestic operating business
of Baxter International Inc. (NYSE: BAX). Baxter International Inc. 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.)
This news release contains forward-looking statements that involve risks
and uncertainties, including technological advances in the medical field,
product demand and market acceptance, actions of regulatory bodies, the
impact of competitive products and pricing, and other risks detailed in
the company's filings with the Securities and Exchange Commission. These
forward-looking statements are based on estimates and assumptions made
by management of the company and are believed to be reasonable, though
are inherently uncertain and difficult to predict. Actual results or experience
could differ materially from the forward-looking statements.
FOR ADDITIONAL
INFORMATION:
 |
- Media Contact:
- Sally Benjamin Young,
847-948-2304
Deborah Spak, 847-948-2349
- Investor
Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
|
| |
|