Take my data please

Take my data, please The Liposome Co. Inc. and NeXstar Pharmaceuticals Inc. went toe to toe last week touting data that each company hopes will help it gain marketing support for its respective lipid amphotericin B product.

Presenting at the Focus on Fungal Infections meeting last week, LIPO said its data showed a statistically significant overall response to its Abelcet amphotericin B compared to NXTR's AmBisome product, while a comparative study conducted by NXTR concluded that AmBisome was significantly less toxic than the LIPO product ( see B9). In LIPO's 75-patient study in fungal infections, overall response was 63 percent (27 of 43 episodes) with Abelcet compared to 39 percent (15 of 39 episodes) with AmBisome on an intent-to-treat basis (p=0.03). However, Michael Hart, CFO at NXTR (Boulder, Colo.) noted that "in our study with our partner Fujisawa, we have remarkably different results." Hart told BioCentury that in the 244-patient trial, AmBisome was significantly less toxic than Abelcet. "The data suggesting that AmBisome is safer balance the equation," said Don Yarson, vice president of sales, marketing and business development at LIPO (Princeton, N.J.). "Furthermore, the two studies give a glimpse that there could be a difference between the two products." Yarson suggested that the pharmacokinetics of AmBisome and Abelcet could differ, causing amphotericin B to be recognized, released and taken up differently. "It's possible that if AmBisome were less toxic, this characteristic could also make it less efficacious," he said. The question remains whether either company's data will sway physicians. Hart believes that NXTR should have an advantage because physicians will look at the type and quality of available data. "Their trial was a prospective, open-label study in 75 patients," he said. "But ours was a double-blinded study of 244 patients." And since both products offer advantages over conventional amphotericin B, "what really matters in these patients is toxicity and side effects." Yarson disagreed. "Fungal infections are very serious - without treatment patients are likely to die," he said. "So the main leverage point of a product should be efficacy." - Steve Edelson ...