Liposome Technology Inc. (LTI) announced thatthe United Kingdom's Medicines Control Agency(MCA) has been satisfied by certain re-evaluatedclinical information on LTI's Amphocil. The MenloPark, Calif., company and its U.K. marketingpartner, Zeneca Pharmaceuticals, are thereforerecommencing with commercialization of thedrug.Amphocil, a lipid-based formulation ofamphotericin B, was approved in the U.K. inAugust for the treatment of fungal infections inwhich toxicity or renal failure precludes use ofconventional amphotericin B, or in cases whereprior systemic anti-fungal therapy has failed. LTIhalted marketing of the drug in late Decemberwhen it decided to reclassify 14 of the 104patients with fungal infection included in theclinical data submitted to U.K. regulators forapproval. Seven patients who were consideredcured by Amphocil in the initial submission werelater deemed non-evaluable because it wasunclear that they had fungal infections.Revised Data Doesn't Affect AprovalAccording to LTI, the MCA has now declaredthat the revised data does not affect the priorapproval of Amphocil.LTI also announced that it has expanded itsdistribution agreement with Zeneca. Under anAugust 1993 agreement, the U.K.pharmaceutical company had exclusive rights tomarket and distribute Amphocil in all majorEuropean markets. Zeneca now has worldwidemarketing and distribution rights to the anti-fungal, excluding the U.S., Canada, Japan and afew smaller markets. LTI will continue tomanufacture Amphocil and sell it to Zeneca.Amphocil is undergoing Phase III clinical testingin the U.S. LTI's stock (NASDAQ:LTIZ) closed at$8.75 per share on Thursday, down 13 cents.
-- Karl A. Thiel Business Editor
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