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Research Triangle Park, N.C. (Dec. 8, 2003)
Bayer Biological Products
(BP) announced today that its extension application requesting approval
for BIO-SET®, a new needleless device for reconstitution
and use of KOGENATE® Bayer (Antihemophilic Factor [Recombinant],
Formulated with Sucrose), has been validated and accepted for review by
the Committee for Proprietary Medicinal Products (CPMP). The Paul-Ehrlich-Institute
(PEI) is acting as rapporteur for the European regulatory submission. Upon
approval, KOGENATE® Bayer with BIO-SET® will
be the first and only self-contained device that provides a prefilled syringe
for rapid and safe reconstitution and infusion without exposed needles.
BIO SET® will be available for hemophilia patients exclusively
with KOGENATE® Bayer, and represents the most advanced technology
available for reconstitution of factor VIII products.
Andreas Mueller-Beckhaus, Ph.D., global project director Kogenate®,
stated, "We are focusing all necessary efforts to accelerate the introduction
of KOGENATE® Bayer with BIO-SET® in all EU
countries. Patients and treaters should benefit as soon as possible from
this new standard of care in hemophilia."
The unique design of KOGENATE® Bayer with BIO-SET®
is expected to provide a new standard in convenience and safety in handling.
Compared to currently available systems, KOGENATE® Bayer
with BIO-SET® involves fewer than half the components, provides
a prefilled syringe requiring the smallest amount of diluent (2.5 mL), and
offers a compact size for easy portability. Additionally, the design of
KOGENATE® Bayer with BIO SET® will advance
patient safety because there is no exposure to needles during the reconstitution
process, no latex utilized in the system, and minimal risk of contamination
during reconstitution because of the special vacuum seal and fewer component
parts. Finally, disposal is easier and safer because no needles are exposed.
"This filing represents a major step forward in convenience and safety
for the European hemophilia community," said Chris Smith, senior vice
president, Bayer BP worldwide sales and marketing. "Certainly the European
market is of critical importance to our business and, upon approval, KOGENATE®
Bayer with BIO-SET® will significantly enhance our presence.
But, more importantly, our objective is to facilitate access to this new
technology for hemophilia A patients and caregivers."
The CPMP filing was submitted in the updated electronic Common Technical
Document format (e-CTD), now the preferred format in the European Union.
This was the first submission the PEI had received in this format and the
first time Bayer had submitted an e-CTD regulatory filing. The e-CTD format
is expected to make the review process more efficient than with paper submissions.
The filing in Europe follows the filing in the United States announced in
November. Additional submissions with regulatory authorities are planned
in Canada, Japan, and other regions of the world. Pending regulatory approvals,
KOGENATE® Bayer with BIO-SET® could be available
for hemophilia patients as early as late-2004.
BIO-SET® is a registered trademark of Biodome.
About Bayer HealthCare
About Bayer HealthCare
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately
9.4 billion Euro in 2002, is one of the world's leading, innovative companies
in the health care and medical products industry.
The company combines the global activities of the divisions Animal Health,
Biological Products, Consumer Care, Diagnostics, and Pharmaceuticals. More
than 34,000 people are employed by Bayer HealthCare worldwide.
Our aim is to discover and manufacture innovative products that will improve
human and animal health worldwide. Our products enhance well-being and quality
of life by diagnosing, preventing, and treating disease.
Information about Bayer Biological Products Division can be found at www.bayerbiologicals.com.
Forward-looking Statements
This news release contains forward-looking statements based on current assumptions
and forecasts made by Bayer Group management. Various known and unknown risks,
uncertainties, and other factors could lead to material differences between
the actual future results, financial situation, development or performance of
the company and the estimates given here. These factors include those discussed
in our public reports filed with the Frankfurt Stock Exchange and with the U.S.
Securities and Exchange Commission (including our Form 20-F). The company assumes
no liability whatsoever to update these forward-looking statements or to conform
them to future events or developments.
Contact:
Tricia McKernan
Tel: 919.316.6316
Fax: 919.316.6673
E-mail: tricia.mckernan.b@bayer.com
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