Healthcare Industry News:  Ortho Biotech Products 

Biopharmaceuticals Oncology

 News Release - June 3, 2006

Study Explores Use of PROCRIT(R) (Epoetin Alfa) Once Every Two Weeks As Initiation Treatment for Chemotherapy-Related Anemia

Study Results Presented at ASCO Annual Meeting

ATLANTA, June 3 (HSMN NewsFeed) -- New study results presented today suggest that 80,000 units of PROCRIT® (Epoetin alfa) administered once every two weeks demonstrated comparable changes in hemoglobin (red blood cell) levels and safety in treating chemotherapy-related anemia in patients with non- myeloid malignancies compared to 40,000 units of PROCRIT once weekly, the current recommended dosage. This study, the first of its kind to evaluate an extended initiation dose of Epoetin alfa in this patient population, was presented today at the 2006 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is expected to be published in the June issue of Current Medical Research and Opinion.

The randomized, open-label, multicenter study compared the response of study patients to 80,000 units of PROCRIT dosed once every two weeks with 40,000 units once weekly. The primary endpoint was the comparison of baseline-to-final hemoglobin levels between the two treatment groups. Secondary endpoints included the assessment of hemoglobin response, time to hemoglobin response, transfusion requirements and safety.

"PROCRIT dosed once weekly is proven and widely accepted for the management of chemotherapy-related anemia," explained the study's lead investigator, David H. Henry, MD, Clinical Professor of Medicine at the Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA. "These findings suggest dosing PROCRIT every two weeks produces similar hemoglobin changes and safety results as once weekly administration. The possibility of administering PROCRIT at a two week dosing interval merits further investigation."

A total of 310 patients with non-myeloid malignancy were enrolled in the study. At entry, patients had hemoglobin levels less than or equal to 11 grams per deciliter (g/dL) of blood and were scheduled to undergo chemotherapy for a minimum of 12 weeks. The patients were randomly assigned to receive one of the two dosing regimens subcutaneously for up to 12 weeks, with dose modifications to maintain hemoglobin levels at approximately 12 g/dL of blood. Breast, lung and colorectal cancer were the most common tumor types at study entry. Almost 50 percent of patients in each group received platinum- containing chemotherapeutic agents.

The average change in hemoglobin levels from the start to the end of the study in the group dosed with 80,000 units every two weeks was 1.6 g/dL of blood. This was statistically comparable to the increase of 1.8 g/dL of blood achieved by the group dosed with 40,000 units weekly. Additionally, of the patients dosed once every two weeks, 9.6 percent required a transfusion between Day 29 and the end of the study compared with 11.1 percent in the patients dosed weekly.

Seventeen patients in each treatment group were withdrawn from the study due to an adverse event, most of which were related to the patient's underlying cancer or chemotherapy. Adverse events were generally consistent with those expected for a population of patients with cancer undergoing chemotherapy. The most frequently reported adverse events were diarrhea, nausea and fatigue. Clinically relevant thrombotic vascular events occurred in eight percent of patients in each group. Nineteen patients died during the study or within 30 days of the last dose of study drug, all of which were deemed by the investigators to be unrelated to the study drug.

Ortho Biotech Products, L.P., the marketer of PROCRIT, supported the study. Dr. Henry, lead investigator of the study, is a consultant to Ortho Biotech Clinical Affairs, L.L.C.

About Chemotherapy-Related Anemia

Anemia is a side effect experienced by 50 to 67 percent of cancer patients undergoing chemotherapy. This potentially life-threatening condition occurs when the body does not have enough red blood cells, which carry oxygen. Oxygen acts like fuel for the body, providing energy for muscles and organs to work. Common symptoms include tiredness, shortness of breath, dizziness, decreased ability to concentrate and sleeplessness.

About PROCRIT® (Epoetin alfa)

PROCRIT is for the treatment of chemotherapy-related anemia in patients with most types of cancer. PROCRIT is available by prescription only and is injected by your doctor or nurse.

Important Safety Information

PROCRIT is not for patients with uncontrolled high blood pressure. High blood pressure has been noted rarely in cancer patients treated with PROCRIT and blood pressure should be monitored carefully. Drugs like PROCRIT may increase the risk of blood clots. In studies, the most common side effects included fever, diarrhea, nausea, vomiting, edema, shortness of breath, tingling and upper respiratory infection.

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About Ortho Biotech Products, L.P.

In 1990, Ortho Biotech Products, L.P. was established in Raritan, N.J. Since that time, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Ortho Biotech, located in Bridgewater, N.J., is an established market leader in Epoetin alfa therapy for anemia management.

Source: Ortho Biotech Products

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