| April 1,
2003
Bayer Biological Products (BP) announced today that it initiated studies earlier this year to confirm that its manufacturing technologies successfully inactivate vaccinia, the live virus utilized in the National Smallpox Vaccination Program. This is the latest measure the company has undertaken in response to patient
concerns that, despite implementation of FDA-recommended donor deferral criteria to eliminate the potential risk of such transmission, donors who have recently been vaccinated for smallpox could inadvertently contaminate blood products
manufactured from their plasma.
Vaccinia and smallpox are viruses that have a lipid membrane, or "envelope" encasing the virus particle. Bayer BP said that the safety steps built into its plasma collection and manufacturing processes include several that are highly effective in inactivating enveloped viruses:
- Solvent/detergent treatment
- Pasteurization, or heat treatment
- Extraction using acetone
- Incubation in acidic solutions
- A new viral inactivation technology utilizing Caprylate
Patients who depend upon blood products first began expressing concerns about possible contamination late last year, when the federal government announced its smallpox vaccination plan. In response to those concerns, Bayer immediately conducted a review of the scientific literature for studies on inactivation of enveloped viruses, including a 1991 paper in the scientific journal Vox Sanguinis authored by two Bayer scientists that specifically references vaccinia.
"These earlier studies indicate that Bayer's manufacturing processes successfully inactivate enveloped viruses and provide us with a significant measure of comfort. Now, we are conducting further evaluations focused solely on vaccinia," said Steve Petteway, Ph.D., vice president of PreClinical Research and Pathogen Safety for Bayer BP. "I'm pleased to report that preliminary data from these studies suggests that the vaccinia virus is in fact inactivated during several steps of Bayer's plasma product manufacturing process. Our goal continues to be to provide the patients we serve with even greater assurance that our products maintain the highest possible safety profile."
That news was well received by organizations whose patients rely on biological and plasma-derived products. "Our patients are among those most at risk of adverse and potentially fatal side effects from exposure to vaccinia." Said Dr. Jonathan Goldsmith, vice president of medical affairs for the Immune Deficiency Foundation, the national organization dedicated to improving the lives of primary immune deficient patients through research and education. "We applaud Bayer for initiating this research and eagerly await its final findings."
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
Bayer Biological Products
+1-(0)919/316-6316
E-mail: tricia.mckernan.b@bayer.com
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