Modeling Simulation Predicts Potential Negative Impact on U.S. Blood Supply if ESA Use Limited for Chemotherapy-Induced Anemia

ATLANTA, December 10, 2007 /PRNewswire/ -- A new analysis presented today at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition predicts that limiting the use of erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) would place considerable pressure on the available marginal U.S. blood supply. Using a modeling simulation technique that allowed for varying the magnitude of reduction in ESA use, findings suggested that even at the lowest reduction evaluated, 25 percent, there was a substantial impact on the available marginal blood supply.

"The nation's blood supply is a limited resource and this analysis underscores the vulnerability of the situation," said Francis Vekeman, M.A., Economist, Groupe d'analyse, Ltee, and lead author of the new analysis. "Given the small margin between usable blood and transfusion demand, understanding the impact of limiting ESA use in cancer chemotherapy patients is essential. Over the last 18 years, a large body of scientific data has demonstrated the ability of ESAs to help patients avoid blood transfusions."

Background

Between 1987 and 1997, the demand for allogeneic blood [whole blood and packed red blood count (RBC)] in the U.S. decreased due to safety concerns. In the same period, the blood supply also decreased, resulting in a 48 percent reduction in the margin between available supply and demand. Despite increases in both supply and demand by 2004, the last year data was available, the margin further declined to only 6.1 percent (allogeneic blood collection of 14.8 million units and transfusion at 13.9 million units). After screening, 240,000 units were rejected leaving a margin of only 648,000 units available, or 4.5 percent of the supply.

Study Methodology

The primary purpose of the study was to estimate the impact of limiting the use of ESAs for CIA patients on the U.S. blood supply.

A modeling simulation was used to compare the number of RBC units transfused in ESA-treated patients to the number of RBC units that would be transfused if ESAs were discontinued or limited in the same population. The excess number of RBC units required if limiting ESA treatment in CIA patients was then contrasted with the available marginal blood supply from 2004.

Inputs to the model included: incident cases of CIA patients treated with an ESA; transfusion rates from clinical trials; and volume of RBC units required for ESA-treated and untreated patients. Estimates were developed for multiple scenarios highlighting various levels of ESA reduction, and sensitivity analyses were conducted using a range of +/- 10 percent for each input parameter.

Study Results

Under the base case scenario, it was estimated that 492,002 CIA patients received a total of 372,809 RBC units despite ESA treatment. Additional estimates are as follows:

     -- A 25% reduction in ESA use would require 18% of the marginal U.S.

        blood supply (incremental RBC units transfused: 118,602 units;

        sensitivity range: 63,030 -- 210,110 units).

     -- A 50% reduction in ESA use would require 37% of the marginal U.S.

        blood supply (incremental demand RBC units transfused: 237,203 units;

        sensitivity range: 126,060 -- 420,220 units).

     -- A 75% reduction in ESA use would require 55% of the marginal U.S.

        blood supply (incremental demand RBC units transfused: 355,805 units;

        sensitivity range: 189,089 -- 630,330 units).

     -- Total cessation of ESA use could exceed the U.S. blood supply

        (incremental RBC units transfused: 474,407 units; sensitivity range:

        252,119 -- 840,441 units).


The added pressure on the blood supply does not consider additional exacerbations due to regional and seasonal variation in the number of available units, as well as donation frequency variations.

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 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 www.orthobiotech.com.

CONTACT: Media, Stephanie Fagan, +1-908-541-4029, or cell,+1-201-572-9581, , for Ortho Biotech Products, L.P. sfagan@obius.jnj.com

Web site: http://www.orthobiotech.com/http://www.procrit.com/

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Posted: December 2007

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