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Executive Summary

AMGEN's G-CSF AND IMMUNEX's GM-CSF WILL BE REVIEWED DEC. 13-14 by FDA's Biological Response Modifers Advisory Committee. In addition to a review of Amgen's white blood cell growth factor, Neupogen, and Immunex's yeast-derived granulocyte macrophage-colony stimulating factor, Leukine, the advisory committee agenda includes an update on gene therapy and a closed session on a pending IND. The meeting will be held at FDA's Parklawn Building, Conference Rooms D&E, beginning at 8:30 a.m. each day. Amgen is scheduled to make a presentation to the committee the morning of Dec. 14 on use of Neupogen for the prevention of infection associated with certain chemotherapeutic regimens of non-myeloid malignancies. The PLA for Neupogen, which has been pending at FDA since Dec. 28, 1989, contains data on more than 700 cancer patients from eight clinical centers in the U.S. and Europe. The company estimates that 250,000 patients in the U.S. could benefit from Neupogen treatment during chemotherapy. Amgen has not filed for Treatment IND status for the product. In addition to the U.S. PLA for Neupogen, registrations were made in the European Community in January 1990 by Amgen's co-marketing partner Roche, which also has filed PLAs with the six European Free Trade Association countries (Switzerland, Sweden, Denmark, Norway, Finland and Holland), New Zealand and South Africa. Amgen has said it plans to seek a number of additional indications for Neupogen. The product is in Phase III as a primary therapy for severe chronic and febrile neutropenia, and for acute myelodysplastic syndrome, a pre-leukemic condition that may affect 50,000 U.S. patients; in addition, Neupogen is in Phase II for bone marrow transplantation and as an adjunct to AZT and ganciclovir therapy in AIDS patients. Immunex's product is scheduled for review in the afternoon of Dec. 13 following the gene therapy update that morning. The session will mark the second time that GM-CSF will be reviewed by the committee for the treatment of patients experiencing engraftment failure after bone marrow transplants. On July 31, the committee recommended the I.V. product for Treatment IND status but concluded there were insufficient data available to recommend approval ("The Pink Sheet" Aug. 6, p. 8). Immunex also plans to present data to the advisory panel on Leukine's broader use in expediting engraftment in bone marrow transplants; the data is in the file of the original PLA. Immunex estimates a patient population of approximately 10,000 could benefit from GM-CSF treatment to expedite engraftment. A Treatment IND for Leukine was approved on Sept. 21 for patients experiencing engraftment failure or delay, putting the drug on the fast track for approval ("The Pink Sheet" Oct. 1, T&G-6). Immunex is providing the product free of charge. The company estimates that approximately 300-600 of the roughly 3,000 bone marrow transplant patients per year have engraftment failure and would benefit from GM-CSF treatment. That approval followed an inspection of Immunex's Seattle, Wash. production facility the week of Aug. 20. Immunex had filed for Treatment IND status on July 23, eight days before the product went before the advisory committee. At its July meeting, the committee reviewed Leukine data on more than 100 patients at 25 clinical trial sites. Members found that most of the patients treated with Leukine had higher neutrophil (infection fighting) counts within two weeks of treatment and that survival rates for patients treated with GM-CSF were higher than historical controls. The committee did not recommend a new study but said it would reassess data on file "as quickly as possible." Immunex said it has complied with the committee's request to supply data on additional patients treated since the PLA was filed Feb. 21. Leukine will be the first therapeutic to be marketed by Immunex. The company regained U.S. manufacturing and marketing rights to the product from Behringwerke in a September 1989 product swap. Hoechst Roussel Pharmaceuticals will market co-market Immunex's GM-CSF in the U.S. under a separate brandname, Prokine. EDITOR's NOTE: Immunex alone, and not Hoechst, holds the PLA for its GM-CSF product and has a Treatment IND approval. In an Oct. 22 item on Hoechst-Roussel's GM-CSF, "The Pink Sheet" (T&G-7) incorrectly reported that Hoechst had a pending PLA and shared the Treatment IND with Immunex. The story incorrectly identified Immunex's GM-CSF brandname as Prokine, the Hoechst product's tradename, and also misidentified Amgen's product as GM-CSF when it is G-CSF.



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