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ROCHE/IMMUNEX IL-2 MARKETING APPLICATION MAY BE DELAYED

Executive Summary

ROCHE/IMMUNEX IL-2 MARKETING APPLICATION MAY BE DELAYED until mid or late 1988 because of FDA interest in seeing data on the use of interleukin-2 administered alone, Immunex President Stephen Duzan stated at a Hambrecht & Quist conference on health care held in San Francisco Jan. 11-13. Noting that Roche has been doing trials with interleukin-2 alone as well as with the LAK administration procedure, Duzan stated that "it is clear now that the FDA will want to see the results of some of those trials where it is being used as a stand alone therapeutic prior to any kind of an approval of the LAK method." Roche licenses interleukin-2 from Immunex. As a result, Duzan continued, "I think that you could all expect that the product license application filings that were anticipated by both our company and our principal competitor, Cetus, at the first part of this year will now be delayed until the mid point of the second half of the year while trials involving the direct administration of interleukin-2 are brought to conclusion." Duzan added that he does not "necessarily think that that means a delay in approval of the product because we have always said that the approval of the LAK method presented some problems for the FDA, problems which would be eliminated if the direct administration method continues to have positive results." In a separate presentation, Cetus President Robert Fildes said that the company plans to file its interleukin-2 application "in 1988." Fildes maintained that Cetus is "on track" with its submission and that discussion of new FDA requirements for interleukin-2 therapy alone are only rumors. Discussing Roche trials of interleukin-2 alone, Immunex President Duzan noted that "those trials have been underway for some time, and the result is that we are seeing data which is comparable in many cases to that which has been obtained with LAK at higher doses." The "early bits of data from those trials have been presented to the FDA, and they have looked at them," Duzan added. "Our understanding is that our principal competitor in this arena has been doing similar kinds of things." Use of interleukin-2 alone, Duzan explained, "would offer the opportunity, obviously, for treating larger numbers of patients. If we are able to achieve similar results as the LAK methodology, there is potential for far less toxicity [and] the treatment would be easier to administer." Duzan noted that "the strategy by Roche from the beginning was to run trials with LAK, but also to look at interleukin-2 as a stand alone therapeutic and in conjunction with both other immune modifiers and chemotherapeutic drugs." Roche and duPont recently announced a research collaboration to use duPont's SteriCell blood processing system to conduct new clinical trials with interleukin-2/LAK. In a Jan. 21 release, the companies explained that the SteriCell "products allow rapid processing of the patient's own blood cells, which are then mixed with IL-2 to produce lymphokine-activated killer (LAK) cells." This technology, the release states, "may prove to be a safer, more efficient and less costly method of producing LAK cells than previous techniques." Roche plans to start studies with the duPont system" in the near future."
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