Procrit (Epoetin Alfa) Data to be Presented at American Society of Hematology Annual Meeting

ATLANTA, December 06, 2007 /PRNewswire/ -- Data from 11 PROCRIT(R) (Epoetin alfa) studies will be presented at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition December 8 - 11, 2007.

    The data will provide important insights including:


    -- the potential impact on the nation's blood supply of limiting the use

       of erythropoiesis-stimulating agents (ESAs) for the treatment of

       chemotherapy-induced anemia (CIA);

    -- the use of PROCRIT in extended dosing regimens;

    -- the use of PROCRIT for treatment of transfusion-dependent anemia in

       patients with myelodysplastic syndromes (MDS);

    -- PROCRIT and real-world practice patterns;

    -- PROCRIT in managed care settings; and

    -- observational data from the Dosing Outcomes Study of Erythropoiesis-

       Stimulating Therapies (DOSE) Registry.

In some cases, the data are from investigational studies and do not reflect current U.S. Food and Drug Administration (FDA)-approved PROCRIT indications or recommended dosage and administration. Please note that all information presented at ASH is embargoed for media release until the data are made available to the public on the ASH Web site.

Data on the Potential Impact on Blood Supply of Limiting ESA Use for Chemotherapy Patients

    -- Poster: Impact of Limiting Erythropoiesis-Stimulating Agent Use for

       Chemotherapy-Induced Anemia on the United States Blood Supply


       Francis Vekeman, M.A., Groupe d'analyse, Ltee, Montreal, Quebec, Canada


       Presentation: Monday, December 10, 2007; 5:00pm - 7:00pm; Hall B3 and

       B4 in the Georgia World Congress Center (Poster Board Number 115,

       Publication Number 2896)


       A modeling simulation was employed to estimate the impact of limiting

       the use of ESAs for CIA on the U.S. blood supply.  The model used a

       top-down approach to compare the number of red blood cell units

       transfused in ESA-treated patients to the number of red blood cell

       units that would be transfused if ESAs were discontinued or limited in

       the same population.


    Data on PROCRIT Investigational Extended Dosing Regimens


    -- Abstract: Early vs. Standard Intervention With an Extended Epoetin alfa

       (EPO) Dose Regimen of 120,000 Units (U) Every 3 Weeks (Q3W) in

       Chemotherapy (CT)-Induced Anemia: Results for Elderly vs. Younger

       Patients in a Randomized Clinical Trial


       Veena Charu, M.D., Pacific Cancer Medical Center, Inc., Anaheim, CA


       Publication Number 3769

       A retrospective subset analysis of a prospective, randomized, open-

       label, multi-center study compared key efficacy and safety results of

       elderly (n=62) and younger (n=73) patients with non-myeloid malignancy.

       Patients with chemotherapy planned for greater than or equal to 9 weeks

       and baseline hemoglobin greater than or equal to 11 and less than or

       equal to 12 grams per deciliter (g/dL) were randomized either to

       "early" intervention with Epoetin alfa or to "standard" intervention

       with Epoetin alfa when hemoglobin decreased to <11 g/dL.


    -- Abstract: Erythroid Response to Epoetin alfa (EPO) 120,000 Units (U)

       Every Three Weeks (Q3W) Initiated Early or at a Standard Threshold in

       Chemotherapy-Induced Anemia (CIA)


       Veena Charu, M.D., Pacific Cancer Medical Center, Inc., Anaheim, CA


       Publication Number 3770

       A retrospective analysis of observed hematologic profiles from a 16-

       week, open-label, randomized study enrolled patients with non-myeloid

       malignancy, baseline hemoglobin greater than or equal to 11 and less

       than or equal to 12 g/dL, and chemotherapy planned for greater than or

       equal to 9 weeks to evaluate whether hemoglobin levels could be

       adequately maintained with Q3W Epoetin alfa initiation treatment.

       Patients were randomized according to study protocol to "early" or

       "standard" intervention groups (n=68 in each group).


    -- Abstract: Investigation of Epoetin alfa (EPO) 80,000 Units (U) Every 4

       Weeks (Q4W) vs. 40,000 U Every 2 Weeks (Q2W) in Patients with Cancer

       Not Receiving Chemotherapy (CT) or Radiation Therapy (RT): Final

       Results


       Daniel Shasha, M.D., Beth Israel Medical Center, New York, NY


       Publication Number 3775

       This prospective, randomized, open-label, multi-center pilot study with

       100 patients with an active non-myeloid malignancy, baseline hemoglobin

       level less than or equal to 11 g/dL, and not receiving or planning to

       receive CT or RT during the course of the study, was designed to

       investigate two novel dosing regimens in this population.  Based on

       recent safety concerns from studies with another ESA in cancer patients

       not receiving CT or RT, enrollment in this study was stopped prior to

       the planned enrollment.

Data on PROCRIT for the Investigational Treatment of Transfusion-Dependent Anemia in MDS Patients

    -- Poster: Treatment of MDS Related Transfusion-Dependent Anemia With

       Epoetin alfa: A Meta-Analysis Perspective


       Suneel Mundle, Ph.D., Ortho Biotech Clinical Affairs, LLC, Bridgewater,

       NJ


       Presentation: Saturday, December 8, 2007; 5:30pm - 7:30pm; Hall B3 and

       B4 in the Georgia World Congress Center (Poster Board Number 625,

       Publication Number 1471)


       A meta-analysis of data extracted from studies found in PubMed,

       American Society of Clinical Oncology (ASCO) and ASH proceedings from

       1990 to 2006 in transfusion-dependent MDS patients (n=578) treated with

       Epoetin alfa plus or minus granulocyte and granulocyte-macrophage

       colony stimulating factors (G/GM-CSF) assessed the efficacy of Epoetin

       alfa in achieving transfusion independence in transfusion-dependent MDS

       patients.


    -- Abstract: Drug Utilization and Cost Considerations of Erythropoiesis-

       Stimulating Agents in Patients with Myelodysplastic Syndromes


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

       Canada


       Publication Number 4611

       A retrospective analysis of medical claims examined Epoetin alfa and

       darbepoetin alfa dosing patterns, ESA treatment costs and red blood

       cell transfusion use in order to characterize real-world utilization of

       ESAs in adult patients with MDS.


    -- Abstract: Assessment of Epoetin alfa in Patients with Myelodysplastic

       Syndrome Utilizing an Electronic Medical Record Database


       Bruce Feinberg, D.O., Georgia Cancer Center Oncology, Decatur, GA


       Publication Number 5180

       A retrospective, observational study, using electronic medical record

       data from a large oncology/hematology practice in the southeastern

       United States, was conducted to gain a better understanding of the

       demographics, real-world treatment patterns and clinical outcomes for

       patients with MDS receiving Epoetin alfa.


    Data on PROCRIT and Real-World Practice Patterns


    -- Poster: Erythropoiesis-Stimulating Agents for Chemotherapy Induced

       Anemia: Analysis of an Electronic Medical Record Database within a

       Large Oncology/Hematology Practice


       Bruce Feinberg, D.O., Georgia Cancer Center Oncology, Decatur, GA


       Presentation: Saturday, December 8, 2007; 5:30pm - 7:30pm, Hall B3 and

       B4 in the Georgia World Congress Center (Poster Board Number 117,

       Publication Number 963)


       A retrospective, observational study using electronic medical record

       data from a large oncology/hematology practice in the southeastern

       United States was conducted to gain a better understanding of real-

       world treatment patterns and clinical outcomes in patients with cancer

       receiving chemotherapy and ESA therapy.


    Data on PROCRIT in Managed Care Settings


    -- Abstract: Drug Utilization Patterns and Cost Considerations for

       Erythropoiesis Stimulating Agents in Cancer Chemotherapy Patients in a

       Managed Care Setting


       Alyson Mandel, Ph.D., Medical Practice Data Corporation, Claverack, NY


       Publication Number 5157

       A retrospective, observational analysis of ESA utilization in more than

       4,100 chemotherapy patients using adjudicated medical claims between

       2004 and 2006 from seven health plans was conducted to understand

       current utilization patterns.  The study examined real-world dosing and

       drug costs for ESAs (Epoetin alfa and darbepoetin alfa) in cancer

       patients receiving chemotherapy.


    -- Abstract: Medical Visit Patterns in Cancer Chemotherapy Patients

       Receiving Erythropoiesis Stimulating Agents in a Managed Care Setting


       Alyson Mandel, Ph.D., Medical Practice Data Corporation, Claverack, NY


       Publication Number 5156

       A retrospective analysis of medical claims between January 2004 and

       December 2005 using the Integrated Health Care Information Systems

       national database and representing more than 35 health plans was

       conducted to describe visit patterns and identify the proportion of

       medical visits made exclusively for ESA treatment in cancer

       chemotherapy patients.


    Observational Data from the DOSE Registry

    -- Abstract: Hemoglobin Levels Prior To Blood Transfusions In Oncology

       Patients Receiving Chemotherapy and Erythropoiesis-Stimulating Agents

       (ESAs): Observational Data from the DOSE Registry


       Kay Larholt, Sc.D., Abt Associates, Lexington, MA


       Publication Number 4019

       A retrospective analysis of real-world data from ESA-treated oncology

       patients obtained from an ongoing prospective, observational registry,

       Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies

       (DOSE), to characterize hemoglobin levels or transfusion triggers.

       Data were collected from participating hospital- and community-based

       outpatient practices between December 2003 and July 2007.

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: Stephanie Fagan, for Ortho Biotech, +1-908-541-4029, or cell,+1-201-572-9581, 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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