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IMMUNEX’s GM-CSF AND CETUS' IL-2 WILL BE REVIEWED JULY 30-31

Executive Summary

IMMUNEX's GM-CSF AND CETUS' IL-2 WILL BE REVIEWED JULY 30-31 at the first meeting of FDA's Biological Response Modifiers Advisory Committee. In addition to Immunex's Leukine and Cetus' Proleukin, the panel will review Schering's alpha interferon Intron A (for a new indication) and Genentech's gamma interferon Actimmune. Genentech's product is scheduled first on the July 30 agenda, followed by Proleukin. Day two of the panel's full slate is set aside for Intron A and Leukine. The panel is scheduled to convene at FDA's Parklawn Building, Conference Rooms D&E beginning at 8:30 a.m. each day. Parts of the gamma interferon, IL-2 and granulocyte macrophage-colony stimulating factor (GM-CSF) presentations are closed. Seattle-based Immunex filed the PLA for its yeast-derived GM-CSF on Feb. 21, a short five months before the product is set to come up for advisory committee review. The firm previously reported that it was seeking expedited review status for the product. The panel will review Immunex's application to market Leukine as an I.V. treatment of "graft failure and loss in bone marrow transplantation." Immunex Chairman Stephen Duzan, speaking last year at an analysts meeting, suggested that the company planned to go first for the bone marrow indications because "strategies developed solely around neutropenia are tough at FDA" ("The Pink Sheet" Dec. 11, T&G-13). GM-CSF study results have shown that the therapy in bone marrow transplantation produces shorter treatment with antibiotics, less transplant toxicity and earlier myeloid engraftment, all leading to shorter and less expensive hospital stays. FDA granted orphan status to GM-CSF June 5 for neutropenia associated with bone marrow transplants, for the promotion of early engraftment and for the treatment of graft failure and delay of engraftment. Leukine will be the first therapeutic developed by Immunex to be marketed by the company. Immunex regained U.S. manufacturing and co-marketing rights to GM-CSF in September through a product swap with Behringwerke ("The Pink Sheet" Sept. 25, p. 13). Hoechst Roussel Pharmaceuticals will co-market GM-CSF in the U.S. under another name. Absent from the agenda of the advisory committee in Schering's GM-CSF product Leucomax, for which the company filed a PLA Jan. 31. Schering is not specifying the exact indication it submitted, saying only that it is for "patients with low white blood cell counts." Schering is in negotiations with FDA about receving expedited review for its GM-CSF. The firm's product will be co-marketed in the U.S. by Sandoz, which licensed GM-CSF from Genetics Institute. Schering, however, will be present at the panel meeting to discuss a hepatitis C indication for Intron A; the product is currently approved for hairy cell leukemia, Kaposi's sarcoma and venereal warts. A supplemental filing for the hepatitis C indication was filed last June when Schering also filed for delta hepatitis. A study published in the Nov. 30 New England Journal of Medicine ("The Pink Sheet" Dec. 4, p. 4) reported that Intron A effectively treated half of the study's non-A, non-B hepatitis patients. The company also filed for a chronic hepatitis B indication in September. The hepatitis indications, some of which are already approved overseas, are expected to help boost Intron A's 1990 sales worldwide by $50 mil. to "more than $130 mil.," Schering Chairman and CEO Bob Luciano told the financial community at a June 20 meeting of the New York Health Care Analyst Group. A 1989 A.D. Little report predicted that the market for alpha interferon products would reach $600 mil. by 1997 ("The Pink Sheet" Sept. 11, p. 20). Genetech, announced Dec. 20 that it had filed the PLA for its biosynthetic gamma-1b interferon product Actimmune for chronic granulomatous disease. The company said then that the orphan disease affects about 250 patients in the U.S., for which it had data on 128 ("The Pink Sheet" Jan. 9, In Brief). Other companies with gamma interferons for other indications include Biogen, Amgen and Chiron. Actimmune is also in Phase III as an adjuvant for small-cell lung cancer and malignant melanoma and for trauma-related infections. Cetus has waited the longest of the four companies coming before the panel. The marketing approval application for Cetus' Proleukin IL-2 -- its first in the U.S. -- has been at FDA since late November 1988 for the treatment of metastatic renal cell carcinoma ("The Pink Sheet" Dec. 12, 1988, T&G-2). One month prior to the Cetus filing, FDA had designated IL-2 an orphan product for the kidney cancer indication. Interestingly, Immunex gets royalties from Proleukin sales based on a 1982 agreement with Roche, for which it helped develop IL-2. Cetus and Roche have a cross-licensing agreement for IL-2 forged last year ("The Pink Sheet" Jan. 2, 1989, T&G-5).
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