IMMUNEX SOLUBLE IL-1 RECEPTOR CLINICALS WILL BEGIN IN 1991

Executive Summary

IMMUNEX SOLUBLE IL-1 RECEPTOR CLINICALS WILL BEGIN IN 1991, Immunex President and Chief Operating Officer Michael Kranda told the Alex. Brown & Sons' health care conference May 9 in Baltimore. "We have produced and are purifying the first human lots of interleukin-1 receptor and will enter clinical trials later this year," Kranda said. The product will be studied first for the treatment of rheumatoid arthritis and prevention of organ transplant rejection. The IL-1 receptor will be the first of Immunex's cytokine receptors to enter the clinic. The company is also working on soluble tumor necrosis factor receptors (for sepsis and septic shock), IL-4 receptors (for immunosuppression, allergy and asthma indications), IL-7 receptors (for immunosupression), and IL-8 receptors (as an anti-inflammatory). Animal studies of the IL-1 receptor marked "the first time that any soluble cytokine receptor had been used therapeutically in an animal model of human disease," Immunex said. A second Immunex compound should enter Phase I this year, Kranda said: PIXY -321, a molecular fusion of IL-3 and GM-CSF (granulocyte macrophage-colony stimulating factor). The drug "can increase both platelet and white blood cell counts," Kranda said. PIXY-321 "a novel approach to combining cytokines," Kranda said. Immunex is using other individual cytokines in combination as well: an IL-1 alpha/GM-CSF combination is in Phase I. Ultimately, because "different cytokines work together in the body," Immunex expects combinations to be the dominant therapy, Kranda indicated. Immunex' first cytokine product, Leukine (sargramostim, GM- CSF) received approval March 5, for the acceleration of myeloid engraftment in autologous bone marrow transplants. Kranda commented on the early results from what he termed a "flawless" launch of the product by Immunex' 42 sales reps. "In the eight weeks since we launched Leukine, we've signed purchase contracts with 21 hospital buying groups," Kranda said. "The hospitals covered under these groups represent one-half of all hospital beds in the U.S." In addition, "hospital formulary presentations and acceptances are building, they're going well," Kranda said. "Our professional services group have responded to literally thousands of inquiries about Leukine from pharmacists and physicians since our launch," he added. "As you attempt to define market share or size," Kranda cautioned the analysts, "bear in mind that it will take months and probably years for the true CSF market picture to develop." Immunex has reported first quarter sales of $ 4.2 mil., including three weeks of Leukine sales. Amgen recently reported that its G- CSF Neupogen posted nearly $ 53 mil. in sales in its first month on the market and has been accepted by 33% of U.S. cancer centers (see related T&G this issue). In addition to evaluating GM-CSF in combination with other cytokines, Immunex is studying Leukine for a host of new indications with the goal of achieving the "broadest possible label," Kranda said. "Results of over 15 clinical studies with GM- CSF" will be presented at the American Society of Clinical Oncology meeting in Houston May 19-21, Kranda noted. While Kranda would neither break out nor project sales figures for Leukine itself, he did predict that Immunex "will break even in 1991 based on cash flow from sales" of the product. Immunex lost $ 9.9 mil. on revenues of $ 34.9 mil. in 1990. Overall, "we have never beeen more secure as a company financially," Kranda said. Immunex has raised more than $ 140 mil. in two public equity offerings in the last year and now has $ 160 mil. in cash on hand. Immunex has "almost no long-term debt," Kranda added.