Vestar Inc. announced Wednesday that AmBisome, itsintravenous liposomal formulation of amphotericin B, hasreceived approval for general sale in Mexico and a speciallicense for sale in Italy.
The drug is a broad-spectrum, anti-infective used to treatpotentially fatal systemic fungal infections.
AmBisome sales in Italy will be restricted to hospitals andwill be based on specific therapeutic need. AmBisome wasapproved in December 1990 for general sale in Ireland.Elsewhere in Europe, it was approved for sale under rulessimilar to the Italian license.
San Dimas, Calif.-based Vestar had $10 million in EuropeanAmBisome sales in the first three quarters of this year. Thecompany is expecting general marketing approvals in theUnited Kingdom and Germany within the next six months, saidMichael Hart, chief financial officer.
Hart estimated a $70 million European market for AmBisometo treat severely ill patients with no alternative treatmentwho can't tolerate amphotericin B.
The size of the Mexican market is harder to gauge, Hart said,but it could be $10 million to $12 million.
Vestar's Italian distributor is BioteKfarma, which will also beresponsible for pursuing expanded registration in Italy. InMexico, Remexa will distribute AmBisome.
Vestar stock (NASDAQ:VSTR) closed at $14, up $1.50 onWednesday.
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