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Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
Date:3/13/2008

GAITHERSBURG, Md., March 13 /PRNewswire/ -- Ortho Biotech is concerned by the Advisory Committee's recommendations to restrict access to erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) in patients with metastatic breast and head and neck cancer, and patients treated with curative intent. The company believes that fully informed patients and their physicians should have the choice to use this important medication, which is the only therapeutic alternative to blood transfusion.

"Over the past several months, the company provided the FDA with substantial new data that give important insight into the safety of ESAs," said Jay Siegel, M.D., Group President, Research & Development. "We hope that the FDA will now take time to review this substantial body of data before reaching its final decision."

The FDA has not yet reviewed new or follow-up survival data accounting for approximately 50 percent of the 7,444 patients in the company's database. The totality of available data support continuing the option to use ESAs according to the label in patients with chemotherapy-induced anemia (CIA).

Out of a total of 59 controlled studies with survival data, the FDA has focused on eight studies of concern. All eight studies researched investigational uses of the drug, and the PROCRIT(R) (Epoetin alfa) label contains specific warnings against such uses.

In addition, a representative of the Cochrane Collaboration who attended the meeting confirmed that the group is about to generate important new analyses regarding the safety of ESA use in CIA. The FDA should consider these analyses before making its final decision.

The current product labeling prominently reflects all known risks of ESAs, including thrombovascular events (TVEs). TVEs are a plausible explanation for increased mortality observed in studies with high hemoglobin (Hb) targets. When ESA use is targeted to Hb higher than 12 grams per deciliter of blood
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