Bayer Announces Additional Prolastin® Safety Measures

Biological Products Division
Bayer Corporation
Post Office Box 13887
79 T.W. Alexander Drive
4101 Research Commons
RTP, NC 27709

February 25, 2003

Dear Alpha-1 Community:

Recently, the CBS news program 60 Minutes aired a segment titled “Bad Medicine,” which recounted in detail how some prescription biological products are tampered with as they pass through the distribution chain from manufacturers to consumers. Recognizing the understandable concerns this report may have caused the Alpha-1 community, I want to briefly outline what Bayer is doing to enhance the safety of our products.

As you know, we developed Bayer Direct™ in response to the unmet needs expressed by the Alpha-1 patient community. This unique, streamlined delivery service was designed to enable Prolastin® Alpha1-Proteinase Inhibitor (Human) patients to receive therapy when and where they need it, directly from the manufacturer. In addition, Bayer Direct™ was created to ensure equitable distribution and consistent pricing. Today, Bayer Direct™ also works to address counterfeiting issues such as those the 60 Minutes episode raised, by minimizing the number of parties that touch Prolastin® before it reaches patients.

And we’re not stopping there. Because we firmly believe that safety is everyone’s responsibility, we are taking additional safety measures. In 2003, Bayer will introduce enhanced tamper-resistant packaging for Prolastin®, thereby providing Bayer’s “seal of protection” against tampering or counterfeiting.

It is our hope that the initiatives Bayer has undertaken in response to this troubling issue will give all of our customers a sense of trust and peace of mind about the safety of our products. Bayer has been serving the Alpha-1 community for more than 15 years, and will remain committed to the needs of this patient community.

If you are interested in a tape of the 60 Minutes episode, please call CBS at 1-800-848-3256. From all of us at Bayer, thank you for your support and the opportunity to continue serving you.

Sincerely,
Terry Tenbrunsel
Vice President, Sales & Marketing
Bayer Biological Products


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