BRIDGEWATER, N.J., Feb. 28 /PRNewswire/ -- Ortho Biotech Products, L.P. today announced that the company is in discussions with the U.S. Food and Drug Administration (FDA) regarding a safety update to the prescribing information of all erythropoiesis-stimulating agents (ESA), including PROCRIT(R) (Epoetin alfa), based on reports from several investigational studies evaluating ESAs. These data may have an impact on labeling in other parts of the world for EPREX(R) (Epoetin alfa), which is marketed by Janssen-Cilag.
Although exact language of this U.S. label update for ESAs has not been finalized, the company expects new information will appear as a boxed warning and will apply to the oncology and nephrology indications for all marketed ESAs.
In addition, the company has been invited to participate in an upcoming Oncologic Drugs Advisory Committee (ODAC) meeting scheduled for May 10, 2007. Ortho Biotech supports the FDA’s mission to inform healthcare professionals and the public regarding the appropriate uses of prescription therapies, and looks forward to further discussion at the upcoming ODAC meeting. Ortho Biotech will actively support the ODAC discussions.
“Ortho Biotech is committed to patient safety and ensuring healthcare professionals are educated about the information in the PROCRIT prescribing information,” said Craig Tendler, M.D., Vice President, Ortho Biotech Clinical Affairs, L.L.C.
When the updated prescribing information becomes available, the company will inform healthcare providers.
About PROCRIT (Epoetin alfa)
PROCRIT is approved for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic kidney disease who are not on dialysis, who are being treated with AZT for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. PROCRIT should be administered in accordance with the dosing and administration section of the labeling to target a hemoglobin of 12 grams per deciliter of blood (g/dL) or less.
Important Safety Information
PROCRIT is contraindicated in patients with uncontrolled hypertension. PROCRIT and other erythropoietic therapies may increase the risk of cardiovascular events (including death), seizures, thrombotic events, and other serious events. The higher risks of cardiovascular events may be associated with higher hemoglobin and/or higher rates of rise of hemoglobin. The target hemoglobin should not exceed 12 g/dL. The dose of PROCRIT should be reduced by 25% as the hemoglobin approaches 12 g/dL or increases by more than 1 g/dL in any 2-week period. Cases of pure red cell aplasia (PRCA) and of severe anemia have been reported in patients with chronic renal failure receiving PROCRIT by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT, accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT and evaluate for the presence of antibodies to erythropoietin. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be switched to other erythropoietic proteins. In studies, the most common side effects included fever, diarrhea, nausea, vomiting, edema, shortness of breath, high blood pressure, headache, joint pain, tingling, and upper respiratory infection.
Please visit www.procrit.com for the full Prescribing Information.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
Forward-Looking Statement
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.
Ortho Biotech Products, L.P.
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