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Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
Date:2/26/2008

JAMA, February 27, 2008 - Vol. 299. No. 8: 'Venous Thromboembolism and

Mortality Associated with Recombinant Erythropoietin and Darbepoetin

Administration for the Treatment of Cancer-Associated Anemia'

BRIDGEWATER, N.J., Feb. 26 /PRNewswire/ -- Ortho Biotech believes that the conclusions of a study published in the February 27, 2008 issue of the Journal of the American Medical Association (JAMA) by Bennett, et al, do not provide an accurate reflection of the safety profile of erythropoiesis-stimulating agents (ESAs) when used for the treatment of chemotherapy-induced anemia (CIA) in patients with cancer.

The company reaffirms that, when used according to product labeling, ESAs remain safe and effective, and are the only proven treatment alternative to blood transfusions for patients with CIA.

Ortho Biotech also provides comment on the following important topics.

Meta-Analyses

Ortho Biotech acknowledges that all meta-analyses have limitations. However, the JAMA authors recognize that a significant limitation of this analysis is that it does not analyze patient-level data from all available controlled studies with ESAs.

In a separate effort, Ortho Biotech, along with the other ESA manufacturers, has provided individual patient-level data to the independent Cochrane Collaboration to support a combined analysis of all available controlled studies with ESAs in oncology patients. This project will be the largest combined analysis of ESA safety data ever undertaken. It will create a database of more than 15,000 patients treated in various clinical studies, which should inform the benefit:risk profile of ESAs by identifying patient subgroups that would benefit from further study.

VTEs

Vascular thrombotic events (VTEs) are a well-recognized risk of ESA treatment and are prominently reflected in the labeling for all ESAs. It is important to understand that VTEs are common in cancer patients. VTEs may
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SOURCE Ortho Biotech
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