Maxim Plans To File Maxamine Malignant Melanoma NDA By Mid-2000
Maxim is targeting a mid-2000 NDA filing for its malignant melanoma immunotherapy Maxamine, which will be followed by European regulatory applications, Maxim CEO Larry Stambaugh told a Burns McClellan/Petkevich & Partners analyst meeting in London Oct. 6.
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Phase III study of histamine dihydrochloride in combination with interleukin-2 for the treatment of malignant melanoma presented June 2 at a melanoma meeting in Pittsburgh. Maxamine significantly improved survival compared to IL-2 monotherapy in a prespecified subset of patients with liver metastases. For the 129 patients with liver metastases, median survival was 287 days in the Maxamine group, compared to 154 days for the control group. In the total group of 305 patients, median survival was 272 days, compared to 245 days for the control group, not a statistically significant difference. Patients who completed two courses of therapy did have a statistically significant difference in survival from the control group, however, as did patients who were at treatment centers experienced with the regimen. The company plans to file an NDA mid-summer (1"The Pink Sheet" Oct. 18, p. 16)
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011