LONDON - Scotia Holdings plc, of Stirling, Scotland, said it is in discussions with six potential pharmaceutical partners for Foscan, its photodynamic therapy for the treatment of head and neck cancer, which has FDA orphan drug and fast-track status. A decision on approval is due by July 2000.
Rob Dow, CEO, told BioWorld International, "We are at an advanced stage of negotiations. At present, we are holding our options open on whether to do a global deal, or a split deal across territories."
Scotia is so confident of getting U.S. and European approval that it has begun work on the marketing strategy and commissioned pharmacoeconomic assessments. "Of course there is no such thing as a dead certainty in this area, but the data is pretty solid," Dow said. He added that he expects the marketing partner to be in place in time for the U.S. approval.
Work also has started on trials in four additional indications for Foscan. In pancreatic cancer, eight of 16 patients treated survived for 12 months or longer and some are still alive. With existing treatments, the median survival for these patients is eight months. "The data are so good we have asked to go and see the FDA to see if we can get fast track," Dow said. Further trials in bone, skin and prostate cancer will begin in the second quarter of 2000.
Studies also have begun with a second photodynamic agent, SQN400, in primary hepatoma and liver metastases. "Based on the preclinical work, we have great hope for this product and again intend to discuss the granting of fast-track status with the FDA because there is currently no reasonable treatment for hepatoma."
The company made these announcements when it released results for the financial year ended December 31, 1999, showing losses up 78 percent to #33.2 million from #18.6 million in 1998. Total sales were #6.3 million, down from #18.6 million in 1998. Of the year-earlier figure, #11.2 million came from businesses Scotia has since disposed of. R&D expenditure rose by 15 percent to #26 million, due to increased spending on Foscan.