LYPHOMED GALLIUM NITRATE NDA TO BE FILED IN SEPTEMBER

Executive Summary

LYPHOMED GALLIUM NITRATE NDA TO BE FILED IN SEPTEMBER for treatment of cancer-related hyper-calcemia, the company announced July 7. The drug is being developed under a research agreement with patent holder Memorial Sloan-Kettering Cancer Center, which has granted LyphoMed exclusive worldwide manufacturing and marketing rights. "Gallium nitrate substantially reduces bone loss, while currently available therapies are far less effective in treating this condition and are excessively toxic," the release states. "Under the research agreement, LyphoMed will support continuing clinical research on gallium nitrate and will undertake the development of an oral form of the drug." The company said it is also planning to file an NDA for treatment of bone metastases "at a later point in time." The agreement with Sloan-Kettering marks another step in the hospital marketer's move into the brand name drug area through the leveraging of its core micronutrient and generic drug business. LyphoMed already markets one proprietary product, Pentam 300, and has at least five more under development, four as orphan drugs. At an Alex Brown health care seminar in May, LyphoMed Senior VP Richard Weiland predicted that the firm may eventually split into two divisions, one for multi-source and one for brand name products ("The Pink Sheet" May 18, T&G-6). Toward that end, the firm's specialty detail force, now at 12 reps, will be expanded to 30 by year-end. Through agreements with NovoPharm and Vestar, LyphoMed has also moved into two other new areas in 1987, oral products marketed to hospitals and liposome-delivered cancer drugs, respectively.