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

New study results presented today
suggest that 80,000 units of PROCRIT(R) (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(R) (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.


Please visit procrit for full prescribing information.


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.


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