Liposome Technology Inc. said Thursday that it has submittedmarketing authorization applications (MAA) for Amphocil in 10European Union (EU) countries, as well as non-EU countries Finlandand Sweden.Last month Liposome launched Amphocil, its lipid-based formulationof amphotericin B, in the U.K., where it was approved in August totreat systemic fungal infections in cases where toxicity or renal failureprecludes the use of conventional amphotericin B, or cases where anti-fungal treatment has failed.The Menlo Park, Calif., company has an agreement with U.K.-basedZeneca Pharmaceuticals for the marketing and distribution ofAmphocil, a colloidal dispersion of submicron-sized particlesconsisting of amphotericin B and sodium cholesteryl. Liposome willmanufacture Amphocil, and sell it to Zeneca, which has rights to theanti-fungal everywhere except North America, Japan and countrieswhere Liposome already had agents before the Zeneca deal _ Ireland,Austria and Israel.Peter Leigh, Liposome's vice president and chief financial officer, toldBioWorld he expects some of the European approvals to come in thefirst half of 1995. He estimated severe systemic fungal diseases afflictsome 250,000 people worldwide, about one-third of whom are inWestern Europe, one-third in the U.S. and the other third in the rest ofthe world. Leigh said the market is increasing rapidly because theinfections are strongly correlated with transplants, particularly bonemarrow.Liposome already has received more than $5 million in signing feesand milestone payments relating to the U.K. approval from Zeneca, andwould receive a similar amount upon further European approvals.Liposome also will get a percentage of sales over the life of the 15-yearagreement."The real value of this transaction to LTI is in the sales we make toZeneca," Leigh said. "That's where the real money is in this deal, if theproduct has the potential we think it has," which he said has beenestimated at between $75 million and $150 million in Europe.Liposome's product will compete for market share in the U.K. _ andlater in other European countries _ with AmBisome, a lipid-basedform of amphotericin B made by Vestar Inc. of San Dimas, Calif.,which it has been marketing since 1989. It is selling about $35 millionworth of product in approved European countries, Leigh said.The alliance with Zeneca, and its large, hospital-based sales force,should ultimately prove enough to overtake Vestar, which markets itsown product, Leigh said. "But the growth will come primarily fromexpansion of the market."In the U.S., Liposome has ongoing Phase III trials of Amphocil in theU.S., one of which is a double-blind study comparing Amphocil toamphotericin B in treating aspergillosis. Those studies are expected toform the basis for filing of a new drug application to the FDA.
-- Jim Shrine
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