Liposome Technology Inc. (LTI) has received approval to market itsanti-fungal drug Amphocil in the United Kingdom, the companyannounced Monday.

The Medicines Control Agency (MCA) approved the anti-fungal drug,which is a liposomal formulation of the broad-spectrum drugamphotericin B, on Aug. 20. The approval is for treating fungalinfections in cases where toxicity or renal failure precludes the use ofconventional amphotericin B or in cases where prior systemic anti-fungal therapy has failed.

The approval comes a mere eight months after LTI (NASDAQ:LTIZ)filed its marketing authorization application (MAA) in the U.K., inDecember 1992, said Peter Leigh, LTI's vice president and chieffinancial officer.

The U.K. approval, which is the first product approval of any sort forLTI of Menlo Park, Calif., follows close on the heels of last week'sagreement with Zeneca Pharmaceuticals under which Zeneca has theexclusive rights to market and distribute Amphocil in Europe.

"We have already initiated plans with Zeneca to prepare for productlaunch in the U.K. market," said Nick Arvanitidis, LTI's chiefexecutive officer.

"It's realistic to expect that actual product launch will take place inthe first quarter of 1994," Leigh told BioWorld. The product will bemanufactured in the U.S. at LTI's facility, which has been makingproduct for somewhat less than a year, and then shipped bulk invials to Zeneca, which will perform the final labeling and shipping,Leigh said. Zeneca will decide how to price Amphocil.

LTI's drug will have to compete for market share in the U.K. withAmBisome, the lipid-based form of amphotericin B made by VestarInc. (NASDAQ:VSTR) of San Dimas, Calif. Vestar, which has beenmarketing its product in Europe since 1989, reported European salesof $28 million last year, according to Michael Walsh, an analyst whofollows LTI for Robertson Stephens & Co.

Assuming that injectable, liposomal versions of amphotericin B aredifferent enough from uncomplexed drugs to constitute a separateclass of drug, Walsh predicted that the total market for theseproducts in Europe will be $100 million in three to four years, withLTI getting $30 million to $40 million of that.

"But a second player can steal market share by product pricing andsales and marketing strategies," he added. For one thing, Vestar isselling AmBisome at a "high price," Walsh said. And for another, LTI'sproduct has an advantage in that it is a one-step reconstitutionprocess, whereas Vestar's requires three steps.

Richard van den Broek, an analyst with Oppenheimer & Co., said thathe expects LTI to grab a share of the market and ultimately expandit due in large part to its relationship with Zeneca, a $6 billion U.K.-based international company recently independent from its parent,ICI Pharmaceuticals.

Van den Broek sees the U.K. approval as a "vote of confidence" forLTI. It demonstrates that LTI is "moving in the right direction ... andprovides the company with a nice bit of momentum, paving the wayfor (other product) milestones this year," he said.

LTI's stock was up 25 cents a share on Monday, closing at $9.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.