Amgen's NEUPOGEN Filgrastim approved for new use in cost-saving cell transplant procedure for cancer treatment; fourth indication shortens hospitalization and patient time at risk.

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 28, 1995--Amgen (NASDAQ:AMGN) today announced that NEUPOGEN (R) (Filgrastim), the company's recombinant granulocyte colony-stimulating factor, has been approved for its fourth indication and the third received in 18 months. The Food and Drug Administration (FDA) has cleared the use of NEUPOGEN to support peripheral blood progenitor cell (PBPC) transplantation. NEUPOGEN-mobilized PBPC transplantation for cancer patients is rapidly replacing bone marrow transplant (BMT) procedures. It provides faster patient recovery, and according to a recent study, does so at approximately 30 percent lower cost.

Physicians are increasingly using NEUPOGEN-mobilized PBPCs in place of BMT because they provide more rapid recovery of patients' white blood cells (neutrophils), red blood cells and cells that prevent bleeding (platelets) following some forms of intensive chemotherapy that suppress the body's ability to form these blood cells.

The faster blood cell recovery resulting from NEUPOGEN shortens the period of time patients are at risk for potentially severe systemic infections, anemia and bleeding complications due to low cell counts. Because cells are mobilized out of the bone marrow to the blood in PBPC transplants, cell collections for this procedure are also much less invasive than bone marrow transplants.

NEUPOGEN-mobilized PBPCs were shown to significantly reduce both the time of hospitalization and the number of platelet transfusions typically needed with bone marrow transplant. There was also significantly faster neutrophil and platelet recovery and the number of days of red blood cell and platelet transfusion were lower than with bone marrow transplants. In all clinical trials of NEUPOGEN for the mobilization of PBPCs, NEUPOGEN was also administered to patients after reinfusion of collected cells. In PBPC clinical trials, NEUPOGEN was generally well tolerated.

"We are pleased that the FDA has recognized the clinical benefits of NEUPOGEN in PBPC transplants and granted its approval," said Gordon Binder, chairman and chief executive officer. "Today's approval is testament to the role of NEUPOGEN in continuing to expand the frontiers of cancer treatment. We will continue to develop additional applications in oncology, HIV and a variety of infectious diseases to benefit patients with serious medical conditions."

PBPC Replacing More Costly BMT

In 1994, approximately 17,000 cell transplants were performed in the United States. Nine thousand of these procedures were PBPC transplants which represented a 30 percent to 35 percent increase from 1993. This increase is primarily attributable to both an increase in the numbers of patients who can benefit from cell transplants and a 50 percent conversion from BMTs.

Previously, cell transplants were performed by surgically removing progenitor cells from the pelvis of either the patient or a donor and then transplanting the blood cells to the patient following myeloablative chemotherapy. However, blood collections for bone marrow transplants are highly invasive and uncomfortable and the procedure requires prolonged hospitalization and can cost $150,000 or more.

"PBPC support has improved the field of stem cell transplant because it enables many patients to tolerate higher doses of chemotherapy which are needed to treat some forms of high risk cancer effectively," said Dr. Elizabeth J. Shpall, associate director, Bone Marrow Transplant Program, University of Colorado Health Sciences Center. "A procedure that provides improved clinical benefits for patients at a lower cost is a true medical advance."

With the PBPC transplant procedure, progenitor cells are removed from the blood instead of from the marrow, a less invasive procedure which can allow patients to recover outside of the hospital setting. Under normal conditions, only small numbers of these blood-forming PBPCs are present in the blood. However, NEUPOGEN increases the release of cells from the bone marrow into the circulation which then can be "harvested" from the blood and stored. After patients have undergone high-dose chemotherapy to kill tumor cells, they receive infusions of the stored NEUPOGEN-mobilized PBPCs. As a result of PBPC infusion, platelets, neutrophils and red blood cells recover more quickly and there is less need for platelet transfusion. Moreover, for many patients, faster blood cell recovery results in fewer days in the hospital.

PBPC-transplant procedures also have been shown to provide a cost advantage over BMT. Results of a 1994 randomized trial comparing BMT using NEUPOGEN and PBPC using NEUPOGEN showed that PBPC patients had significantly shorter hospitalization, time to neutrophil restoration (11 versus 14 days), time to platelet recovery (16 versus 23 days) and fewer platelet transfusion days (six versus 10 days). In this trial, resource utilization data were collected prospectively in order to evaluate the economic implications of PBPC transplantation. The economic analysis of this study, presented at last May's annual meeting of the American Society of Clinical Oncology (ASCO), revealed that the mean price associated with the PBPC procedure is 30 percent lower than the mean price of the BMT procedure.

Last January, the European Committee on Proprietary Medicinal Products (CPMP) recommended approval of NEUPOGEN for PBPC transplantation in the European Union. Nearly all of the individual countries have since formally approved this use, including France, the United Kingdom, Ireland, Spain, Luxembourg, Austria, the Netherlands, Sweden, Switzerland, Germany, Belgium and Denmark.

NEUPOGEN has been marketed in the United States as an adjunct to chemotherapy since 1991. It is used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever and, in June 1994, was approved to reduce the duration of neutropenia following allogeneic and autologous bone marrow transplantation. NEUPOGEN was also licensed in December 1994 to prevent infections in people with severe chronic neutropenia (SCN), a rare, potentially life-threatening blood disorder in which the body fails to manufacture sufficient infection-fighting white blood cells.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advanced cellular and molecular biology.

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