Procrit (Epoetin Alfa) Data to Be Presented at American Society of Nephrology Annual Meeting

SAN FRANCISCO, November 01, 2007 /PRNewswire/ -- Data from six studies of PROCRIT(R) (Epoetin alfa) will be presented at the 40th annual meeting of the American Society of Nephrology (ASN) on November 2 - 5, 2007.

Several of these studies provide information on issues that have been the subject of recent scientific and regulatory discussions about appropriate use of erythropoiesis-stimulating agents (ESAs). These include data related to cardiovascular outcomes, hemoglobin stability, and hemoglobin response relative to ESA dosing in chronic renal failure (CRF) patients with anemia.

In some cases, the data are from investigational studies and do not reflect current Food and Drug Administration (FDA)-approved PROCRIT indications or recommended dosage and administration.

Please note that all information presented at the ASN is embargoed for media release until one hour after the time of presentation.

    PROCRIT Data To Be Presented at ASN


    -- Impact of Anemia on Cardiovascular Disease-Related Hospitalizations in

       Patients With Pre-Dialysis Chronic Kidney Disease


       Julien Foreix, M.A., Groupe d'analyse, Ltee, Montreal, Quebec


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center (Poster Board Number SU-PO1008)


       This 4,177-patient retrospective open-cohort study investigated whether

       hemoglobin (Hb) levels were associated with reduced risk of

       cardiovascular disease (CVD)-related hospitalizations among anemic

       patients with pre-dialysis chronic kidney disease (CKD).


    -- Analysis of Hemoglobin Decline Following Hemoglobin Increase to >12

       g/dL When Initiating Epoetin Alfa Using Extended Dosing Regimens


       Tracy McGowan, M.D., Ortho Biotech Clinical Affairs


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center (Poster Board Number SU-PO786)


       An open-label, multicenter trial was performed to assess the Hb

       response to Epoetin alfa (EPO) in 109 pre-dialysis CKD patients with

       anemia who were randomized to subcutaneous EPO regimens of 10,000 Units

       (U) weekly (QW), 20,000 U every two weeks (Q2W), 20,000 U every four

       weeks (Q4W) or 40,000 U Q4W for 16 weeks.


    -- Hemoglobin Stability With Extended Dosing of Epoetin Alfa in Pre-

       Dialysis CKD Patients


       Robert Bailey, M.D., Ortho Biotech Clinical Affairs


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center (Poster Board Number SU-PO778)


       EPO data from two recently published clinical trials were utilized for

       this exploratory analysis of 361 subjects: a 16-week maintenance study

       that assessed the efficacy of different extended dosing regimens of EPO

       in maintaining Hb in the 11-13 g/dL range; and a 28-week initiation

       study that assessed the efficacy of an EPO Q2W regimen in achieving and

       maintaining Hb in the 11-12 g/dL range.


    -- Pharmacokinetics and Pharmacodynamic Profiles of Epoetin Alfa (EPO) in

       Anemic Subjects With Chronic Kidney Disease


       Tracy McGowan, M.D., Ortho Biotech Clinical Affairs


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center (Poster Board Number SU-PO787)


       This open-label, randomized study was performed to characterize the

       pharmacokinetic (PK) and pharmacodynamic (PD) profiles of four dosing

       regimens of EPO administered subcutaneously in subjects with anemia of

       CKD.  Forty subjects were randomized equally to one of four dosing

       regimens: 50 IU/kg three times per week, 10,000 IU once weekly, or

       20,000 IU every two weeks for 36 days; or 40,000 IU every four weeks

       for 64 days.


    -- Drug Utilization and Associated Costs of Erythropoietic Stimulating

       Agents in Pre-Dialysis Chronic Kidney Disease Patients


       John J. Barron, PharmD, Ortho Biotech Clinical Affairs


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center (Poster Board Number SU-PO102)


       This retrospective, observational study was performed to analyze

       current dosing patterns and associated costs of EPO and darbepoetin

       alfa (DARB) in pre-dialysis CKD patients.  Dosing frequency, duration

       of therapy, mean cumulative dose and wholesale acquisition prices were

       calculated for each group; 1,044 patients met inclusion criteria.


    -- Drug Utilization and Costs for Erythropoietic Stimulating Agents in a

       Managed Care Population With Hypertension and Chronic Kidney Disease


       Francois Laliberte, M.A, Group d'analyse, Ltee, Montreal, Quebec


       Sunday, November 4; 10:00 am - 12:00 pm; Main Hall, Room 3001, Moscone

       Center  (Poster Board Number SU-PO1020)


       This retrospective analysis of 475 patients receiving an ESA examined

       current utilization and corresponding costs of EPO and DARB in patients

       with hypertension and pre-dialysis CKD.

About PROCRIT (Epoetin alfa)

PROCRIT is indicated 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

    From the Boxed Warnings

    -- Use the lowest dose of PROCRIT that will gradually increase the

       hemoglobin (Hb) concentration to the lowest level sufficient to avoid

       the need for red blood cell (RBC) transfusion.

    -- PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased

       the risk for death and for serious cardiovascular events (including

       serious arterial and venous thromboembolic events, myocardial

       infarction, stroke, congestive heart failure) when administered to

       target a Hb of greater than 12 g/dL.  A rate of hemoglobin rise of

       greater than 1 g/dL over 2 weeks may also contribute to these risks.


    -- Cancer patients: Use of ESAs:

       -- Shortened the time to tumor progression in patients with advanced

          head and neck cancer receiving radiation therapy when administered

          to target a Hb of greater than 12 g/dL.

       -- Shortened overall survival and increased deaths attributed to

          disease progression at 4 months in patients with metastatic breast

          cancer receiving chemotherapy when administered to target a Hb of

          greater than 12 g/dL.

       -- Increased the risk of death when administered to target a Hb of 12

          g/dL in patients with active malignant disease receiving neither

          chemotherapy nor radiation therapy.  ESAs are not indicated for this

          population.


    -- Patients receiving PROCRIT pre-operatively for reduction of allogeneic

       RBC transfusions: A higher incidence of deep venous thrombosis was

       documented in patients receiving PROCRIT who were not receiving

       prophylactic anticoagulation.  Antithrombotic prophylaxis should be

       strongly considered when PROCRIT is used to reduce allogeneic RBC

       transfusions.

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

    -- Monitor Hb regularly during therapy, more frequently following a dosage

       adjustment or until Hb 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.

    -- 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 Warning.

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: Stephanie Fagan, +1-908-541-4029 office, +1-201-572-9581 cell, sfagan@obius.jnj.com

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

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Posted: November 2007

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