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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 be underdiagnosed as a cause of death in cancer patients. For this reason, it is plausible that unrecognized VTEs are a potential explanation for increased mortality with ESAs in cancer patients, especially in those studies with high hemoglobin targets.

Mortality

Out of a total of 59 controlled studies for which mortality information has been reported, the U.S. Food and Drug Administration has characterized eight investigational studies as reporting that patients receiving ESAs had decreased overall survival and/or tumor progression compared with the control group. All eight studies were conducted in settings inconsistent with the current product label. The safety findings from these eight studies conducted outside the label have raised important questions that will be addressed through further research and risk minimization activities.

EPO Receptors

The data remain inconclusive on the hypothesis that the expression of erythropoietin receptors on tumor cells can lead to shortened survival in cancer patients. The company has proposed unrestricted funding to support independent research through the National Cancer Institute to address this hypothesis.

Ortho Biotech fully supports direction to healthcare professionals to use the lowest dose of ESAs that will gradually increase the hemoglobin concentration to a level that will avoid the need for a blood transfusion. The company believes that ESA product labeling prominently reflects all known risks of ESAs, including VTEs, when used according to the label, and increased VTEs and mortality, when used to treat beyond the correction of anemia or in cancer patients not on chemotherapy.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with advanced breast, head and neck,

lymphoid, and non-small cell lung malignancies when dosed to target a

hemoglobin of greater than or equal to 12 g/dL.

-- The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

-- To minimize these risks, as well as the risk of serious cardio -- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

-- Use only for treatment of anemia due to concomitant myelosuppressive

chemotherapy.

-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

-- The dose of PROCRIT should be titrated for each patient to achieve and

maintain the following hemoglobin levels:

* Chronic renal failure patients -- hemoglobin levels between 10 to 12

g/dL. If a patient does not attain hemoglobin levels of 10 to 12

g/dL despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and

ADMINISTRATION in the PROCRIT Prescribing Information.

* Cancer or HIV patients -- the lowest hemoglobin level sufficient to

avoid transfusion and not to exceed 12 g/dL.

-- Monitor hemoglobin regularly during therapy, more frequently following

a dosage adjustment or until hemoglobin becomes stable.

-- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or

without other cytopenias, associated with neutralizing antibodies to

erythropoietin 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 other

erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or

1-888-227-5624) to perform assays for binding and neutralizing

antibodies. If erythropoietin antibody-mediated anemia is confirmed,

PROCRIT should be permanently discontinued and patients should not be

switched to other erythropoietic proteins.

-- The safety and efficacy of PROCRIT therapy have not been established in

patients with a known history of a seizure disorder or underlying

hematologic disease (e.g., sickle cell anemia, myelodysplastic

syndromes or hypercoagulable disorders).

-- In some female patients, menses have resumed following PROCRIT therapy;

the possibility of pregnancy should be discussed and the need for

contraception evaluated.

-- Prior to and regularly during PROCRIT therapy monitor iron status;

transferrin saturation should be greater than or equal to 20% and

ferritin should be greater than or equal to 100 ng/mL. During therapy

absolute or functional iron deficiency may develop and all patients

will eventually require supplemental iron to adequately support

erythropoiesis stimulated by PROCRIT.

-- During PROCRIT therapy, blood pressure should be monitored carefully

and aggressively managed, particularly in patients with an underlying

history of hypertension or cardiovascular disease.

-- In studies, the most common side effects included fever (pyrexia),

diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or

loss of strength or weakness (asthenia, fatigue), shortness of breath,

high blood pressure, headache, joint pain (arthralgias), abnormal skin

sensations (as tingling or tickling or itching or burning;

paresthesia), rash, constipation and upper respiratory infection.

Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.

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 http://www.orthobiotech.com.


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SOURCE Ortho Biotech
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