New drug indication could reduce need for blood transfusion in some surgeries

Business Wire, Dec 26, 1996

RARITAN, N.J.--(BUSINESS WIRE)--Dec. 26, 1996--

Enables body to act as blood bank by increasing red blood cells

PROCRIT(R) (Epoetin alfa), a leading biotechnology drug currently marketed for the treatment of anemia in certain conditions, is the first drug to receive marketing clearance by the U.S. Food and Drug Administration to reduce the need for blood transfusions in anemic patients scheduled to undergo elective non-cardiac, non-vascular surgery.

PROCRIT stimulates the production of red blood cells prior to surgery to counter the effects of blood loss during some surgical procedures. PROCRIT, which is marketed by Ortho Biotech Inc. and manufactured by Amgen Inc., is a genetically engineered version of the body's natural hormone, erythropoietin. Produced primarily in the kidneys, erythropoietin stimulates the bone marrow to produce red blood cells.

"PROCRIT essentially allows the body to act as its own blood bank by building a reserve of red blood cells," said Thomas P. Sculco, M.D., Director of Orthopedic Surgery, The Hospital for Special Surgery, New York. "If patients have higher red blood cell counts before their surgery, clinical evidence demonstrates they are less likely to need transfusions."

PROCRIT is expected to be used in a variety of elective surgical procedures that often involve blood loss requiring transfusions, including orthopedic procedures, such as hip and knee replacements, which typically are scheduled ahead of time.

Orthopedic surgical procedures represent a major demand on the nation's blood supply. The U.S. Department of Health and Human Services estimates that more than 400,000 hip and knee replacements will be conducted this year, and blood transfusions will be required in many of these procedures.

In a study of 316 patients scheduled for major elective orthopedic surgery, daily pre-, peri-, and post-surgical administration of PROCRIT reduced the need for transfusion of donor blood. In a subgroup of mildly anemic patients, only 16 percent of PROCRIT-treated patients received a transfusion, compared to 45 percent of patients who received placebo. An additional study of 145 patients showed comparable efficacy to the daily schedule with a weekly dose administered prior to and on the day of surgery. All patients received anticoagulant therapy.

"In orthopedic surgery, many of our procedures have significant blood loss," Dr. Sculco added. "PROCRIT is a major advance in our ability to manage that blood loss in select anemic patients who are undergoing these complex procedures."

PROCRIT can be administered once weekly for three weeks before surgery and on the day of surgery by injection under the skin. It also can be administered daily for a 15-day perioperative period. PROCRIT will be marketed for use in the treatment of anemic patients with hemoglobin levels between 10-13 grams per deciliter (greater than 10g/dL to less than or equal to 13g/dL). Hemoglobin is the iron-containing substance in red blood cells that delivers oxygen throughout the body.

The most common side effects with PROCRIT were fever, nausea and constipation, which were comparable to the incidence of side effects of patients taking placebo. Although there was no increase in the incidence of thromboembolic events in this study, the risk of post-operative thrombotic/vascular events cannot be excluded.

PROCRIT(R) is already marketed for treating the anemias associated with chemotherapy in non-myeloid (solid and most hematologic) cancers, AZT-treated HIV-positive patients, and chronic renal failure pre-dialysis. This new indication will be available immediately by prescription.

Ortho Biotech was established in 1990 by Johnson & Johnson as the first biotechnology subsidiary of a major health care company. -0- (Full prescribing information available on request).

CONTACT: Ortho Biotech Inc.

Craig Rothenberg, 908/218-6090

or

Moran Communications

Lindy Moran, 212/966-4187