Healthcare Industry News:  Ortho Biotech 

Biopharmaceuticals

 News Release - December 8, 2006

Majority of Cancer-Related Anemia Patients Treated With PROCRIT(R) (Epoetin Alfa) Once Every Three Weeks Achieved Target Hemoglobin

ORLANDO, Fla., Dec. 8 (HSMN NewsFeed) -- New investigational study results report that 80,000 units of PROCRIT® (Epoetin alfa) administered once every three weeks may increase hemoglobin (Hb) levels and improve quality of life in patients with non-myeloid malignancies who are not receiving chemotherapy or radiation therapy.(1) The study is published in the November supplement of the medical journal Blood as part of the American Society of Hematology (ASH) 48th Annual Meeting and Exposition.

PROCRIT is approved by the FDA for reducing transfusion requirements in non-myeloid cancer patients with anemia due to chemotherapy. The recommended starting dose for patients with chemotherapy-related anemia is 40,000 units once weekly.

In this study, 75.5% of patients (37/49) treated with PROCRIT achieved a hematopoietic response (HR), defined as an increase in Hb of 2 grams per deciliter (g/dL) of blood and/or achieving a target Hb 12 g/dL during the study, independent of blood transfusion within 28 days. PROCRIT-treated patients also demonstrated significant improvements from baseline in quality of life based on measures of energy level, improvements in daily activities, and overall quality of life.

"Once-weekly PROCRIT is a proven and widely accepted therapy for the management of chemotherapy-related anemia. But, as many as 40 percent of cancer patients who are not receiving chemotherapy or radiation treatment also experience anemia as it is not diagnosed or treated," said Daniel Shasha, MD, Assistant Professor, Department of Radiation Oncology at Beth Israel Medical Center, New York. "These investigational findings suggest dosing PROCRIT every three weeks may increase hemoglobin in many of these patients."

Study Methodology

The trial evaluated HR rates to PROCRIT 80,000 units dosed once every three weeks in 49 patients with non-myeloid malignancies. The most common tumor types were breast (n=12, 24.5%) and prostate (n=12, 24.5%). Inclusion criteria included a baseline Hb <11 g/dL, no chemotherapy administration within eight weeks or radiation therapy within four weeks of entering the study, and no plans to receive these therapies during the study period. The average age was 71 and average baseline Hb was 10.3 g/dL.

Treatment was administered at Weeks 1, 4, 7, and 10 with follow-up continuing to week 13. PROCRIT treatment was reduced for a Hb greater than 12 g/dL or a Hb increase greater than 1.5 g/dL in any three-week period. Dose was withheld for a Hb greater than 13 g/dL, then reduced when Hb was less than or equal to 12 g/dL.

Study Results

Overall, 75.5% of patients achieved HR. The mean time to the first HR was 5.76 weeks. In addition, 79.6% (39/49) of patients achieved a 1 g/dL increase in Hb from baseline in an average of 3.77 weeks. From Day 29 to end of study, 2/49 (4.1%) patients received a red blood cell transfusion. In 24 of 51 patients (47.1%), at least one dose was reduced or withheld.

PROCRIT was generally well tolerated among patients. Adverse events that were reported in over 5 percent of the population included arthralgia (joint pain), back pain and vomiting. One non-clinically relevant thrombotic vascular event of chest pain was reported.

Ortho Biotech Products, L.P., markets PROCRIT and supported the study. Dr. Shasha, principal investigator of the study, is a consultant to Ortho Biotech Clinical Affairs, L.L.C.

About Anemia

Anemia, a 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 and for the treatment of anemia in chronic kidney disease patients who are not on dialysis. PROCRIT is available by prescription only and is injected by a doctor or nurse. PROCRIT has been prescribed for more than 10 years to treat anemia in patients with chronic kidney disease not on dialysis.

Important Safety Information

PROCRIT is not for patients with uncontrolled high blood pressure. High blood pressure has been noted in patients treated with PROCRIT and blood pressure should be monitored carefully. Drugs like PROCRIT may increase the risk of blood clots and seizures. Loss of response to PROCRIT could be a sign of a very rare but serious condition. In studies, the most common side effects were high blood pressure, headache, joint pain, and nausea. Please visit www.procrit.com for important product information.

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, NJ, 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.

(1) Please see study methodology and results sections for details on study design and considerations for interpreting results. Shasha, D., Dawkins, F., Wilhelm, F. "Epoetin alfa 80,000 U Every Three Weeks (Q3W) in Anemic Cancer Patients Not Receiving Chemotherapy or Radiation Therapy." Abstract published in the November supplement of the medical journal Blood as part of the 2006 American Society of Hematology (ASH) annual meeting.


Source: Ortho Biotech Products

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