AMGEN's NEUPOGEN SUPPLEMENTAL PLA FOR SEVERE CHRONIC NEUTROPENIA

Executive Summary

AMGEN's NEUPOGEN SUPPLEMENTAL PLA FOR SEVERE CHRONIC NEUTROPENIA is expected to be filed during 1992, company officials said. During a Dec. 3 presentation to the Mabon Securities Research Conference in New York City, Amgen Chief Financial Officer Lowell Sears commented that studies for use of the granulocyte colony stimulating factor for "severe and chronic neutropenia, this is both congenital and idiopathic, [are] in Phase III and in fact we are readying that for filing with the regulatory authorities." Neupogen was approved in February for treating neutropenia that results from myelosuppressive chemotherapy ("The Pink Sheet" Feb. 25, p. 5). Phase III studies are continuing for use of the G-CSF product for bone marrow transplantation (BMT), nonchemotherapy-induced febrile neutropenia and myelodysplastic syndromes. Sears said the "largest market opportunity is in infectious disease; we have commenced trials there. We have Phase I/II trials under way in burn patients, head injury, trauma and community-acquired pneumonia." Neupogen also is in Phase II for AIDS use. While Sears remarked that Amgen has "only begun to penetrate the adjunct chemotherapy indication" with Neupogen, company utilization figures suggest the product is gaining a foothold in treatment settings for the additional indications still under study. About 85% of Neupogen utilization is "in the oncology setting, the adjunct to chemotherapy," Sears said. "Outside of that, we are seeing utilization, although we're not promoting the drug for these uses . . . in the area of AIDS, BMT, the infectious disease uses." As of mid-September, Amgen data show, 80% of U.S. oncologists had prescribed Neupogen at least once as had "nearly 80%" of infectious disease specialists, Sears said. While most of the latter physicians were also prescribing the product for cancer patients, Sears said it is "quite good" that infection specialists are getting "hands-on" experience with the product. Sears reported that Amgen already is "seeing a substantial use of Neupogen in BMT; in our surveys we have roughly a 50% market share of BMT without it being on our label specifically," he said. While stressing that the Neupogen C-CSF product is not "directly comparable" to GM-CSF products, Sears also said that when "we look at the hospital market share of colony stimulating factors . . . we have roughly an 86% market share. That has been a stable to slightly increasing share over time." Neupogen sales were about $ 145 mil. through Sept. 30. Amgen is anticipating a continued 7% to 8% annual increase in the number of patients utilizing its recombinant erythropoietin product Epogen for renal dialysis-induced anemia - more if the company persuades FDA to raise the hematocrit target levels for use of the product. Epogen was approved in June 1989 with product labeling indicating its use for bringing end-stage renal disease (ESRD) patients' hematocrit levels up to a range of 30%-33% of red blood cell count. Sears said that under the current indication, about 75% of Medicare ESRD-program patients are "EPO-eligible based on their hematocrit or red blood cell count." If Amgen is "successful in increasing the hematocrit level, then the penetrable patient population would increase somewhat faster, as much as 90% of the total dialysis patient population." Sears also noted an increase in the dosages of Epogen used, with an upturn occurring in early 1991 as a result of Medicare payment changes. Medicare initially had set a flat rate for EPO,but Congress, concerned that the policy both overpaid dialysis centers and encouraged the underdosing of patients, directed that rates be based on the amount of the product actually used ("The Pink Sheet" July 15, T&G-10). Sears said this payment change "has increased the dosage," although the amount of increase is beginning "to taper off."