Liposome Technology Inc. (LTI) announced Tuesday that it hasfiled a product license application (PLA) in the United Kingdomfor its lipid-complexed amphotericin B product, Amphocil.
The PLA represents the Menlo Park, Calif., company's first bidto market Amphocil anywhere in the world.
LTI has requested approval of Amphocil for the treatment oflife-threatening fungal infections in cases where toxicity orrenal failure precludes the use of conventional amphotericin B,or in cases where prior anti-fungal therapy has failed.
"It's my understanding that the approval process in the U.K.can take anywhere from six months to a year," Peter Leigh,LTI's vice president of finance, told BioWorld. Leigh said thatapplications to market Amphocil in other countries within theEuropean Common Market will follow in the first quarter ofthis year.
Vestar Inc. (NASDAQ:VSTR) of San Dimas, Calif., and TheLiposome Company Inc. (NASDAQ:LIPO) of Princeton, N.J., arealso major players in the area of lipid-based drug deliverytechnology. Vestar's formulation of amphotericin B, Ambisome,is currently being sold in at least 21 European countries andgenerates annualized sales of more than $25 million. TheLiposome Company plans to file an application for itsamphotericin B formulation by the fourth quarter of this year.
Amphotericin B is a potent anti-fungal agent, but it is highlytoxic to humans. When formulated or, in some cases, "coated" inlipid compounds, it becomes far less toxic and can beadministered at higher doses. All three companies are workingon technologies to diminish the drug's toxicity whilemaintaining its efficacy.
According to Leigh, Amphocil may offer at least one advantageover Ambisome. "Reconstituting Amphocil is a one-stepprocess; it comes freeze-dried in a vial, and when you addwater it dissolves, not unlike Alka Seltzer," said Leigh. "TheVestar product has to be cooled, heated and then re-cooled in areconstitution process that can take from 30 to 35 minutes. Ina busy hospital setting, we think this could be a significantmarketing advantage."
But Michael Hart, Vestar's chief financial officer, said thatdifferences in reconstitution procedures of the two drugs is"insignificant to the hospital and to the patient."
"The real story here is that Ambisome is an approved product.We have 60 to 70 percent market share in the U.K.," Hart said."Amphocil now becomes a 'me-too' product in the U.K. Andhistorically, European regulatory agencies are slower inreviewing 'me-too' products."
Liposome Technology (NASDAQ:LTIZ) stock closed Tuesday at$10.38, up 25 cents per share.
-- Lisa Piercey Business Editor
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