DALLAS, April 4, 2008 Data from five studies sponsored byOrtho Biotech Products, L.P. will be presented at the National KidneyFoundation (NKF) 2008 Spring Clinical Meetings from April 2 - 6, 2008; threeutilization studies involve PROCRIT(R) (Epoetin alfa).
The data include studies that compare drug utilization patterns and costsof PROCRIT (EPO) and darbepoetin alfa (DARB), evaluate medical costs relatedto chronic kidney disease (CKD) patients with hypertension or diabetes, andshow the impact on hemoglobin (Hb) control using a software-based managementtool. These retrospective analyses used data from actual clinical practice.
Data on Drug Utilization Patterns and Costs of Epoetin Alfa andDarbepoetin Alfa
Data on Medical Costs Related to Chronic Kidney Disease Patients withHypertension or Diabetes
Data on the Impact on Hemoglobin Control Using a Software-Based ManagementTool
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types ofcancer receiving chemotherapy, with chronic renal failure who are on dialysisand those who are not on dialysis, who are being treated with zidovudine forHIV infection, and to reduce the need for transfusion in anemic patients whoare scheduled for elective noncardiac, nonvascular surgery. Depending on thecountry in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR andTHROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and seriouscardiovascular events when administered erythropoiesis-stimulating agents(ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve andmaintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses inpatients not receiving prophylactic anticoagulation. Consider deep venousthrombosis prophylaxis.
PROCRIT is contraindicated in patients with uncontrolled hypertension orwith known hypersensitivity to albumin (human) or mammalian cell-derivedproducts.
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 companydevoted to helping improve the lives of patients with cancer and with anemiadue to multiple causes, including chronic kidney disease. Since it wasfounded in 1990, Ortho Biotech and its worldwide affiliates have earned aglobal reputation for researching, manufacturing and marketing innovativeproducts that enhance patients' health. Located in Bridgewater, N.J., OrthoBiotech is an established market leader in Epoetin alfa therapy for anemiamanagement. The company also markets treatments for recurrent ovarian cancer,rejection of transplanted organs and other serious illnesses. For moreinformation, visit www.orthobiotech.com.-- Abstract: Assessment of Drug Utilization Patterns and Costs for Erythropoietic Stimulating Agents in Patients with Chronic Kidney Disease Patrick Lefebvre, M.A., Groupe d'analyse, Ltee, Montreal, Quebec, Canada A retrospective analysis of medical claims was conducted using the Ingenix Impact National Managed Care Database to examine recent EPO and DARB treatment patterns and corresponding drug costs in newly-initiated CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving dialysis. Mean cumulative dose was used to calculate drug costs based on October 2007 wholesale acquisition unit prices. -- Abstract: Drug Utilization and Cost Considerations of Predialysis