TLC Applies to Market ABLC in Europe
The Liposome Company Inc. (TLC) announced Tuesday at theconference that it has filed marketing applications foramphotericin B lipid complex (ABLC) in six European countries.
ABLC is a therapeutic for the prevention of fungal infections inpatients undergoing bone marrow transplants. TLC(NASDAQ:LIPO) of Princeton, N.J., is currently enrolling patientsfor a Phase II/III trial in the U.S.
In this study, thirty patients undergoing bone marrowtransplant will receive the drug to evaluate its safety.Subsequently, 400 patients will be randomized to receiveeither ABLC or placebo following bone marrow transplant. Thestudy will compare rates of fungal infections in the twopopulations. Phase III trials planned for 1994 will include anevaluation of the drug in the treatment of the most commontypes of life-threatening fungal infections.
Charles Baker, TLC's chairman and chief executive officer, alsosaid at H&Q that the company plans to file marketingapplications for ABLC in 10 additional countries this year.Baker told BioWorld that TLC filed the applications over thepast several weeks, but he would not specify which countriesthey were filed in, saying only that they were made in thecountries with the largest sales potential.
ABLC is the first therapeutic agent for which TLC has soughtmarketing approval, Baker said. The company startedoperations in 1982. A liposomal formulation of amphotericin B,AmBisome has been marketed in Europe by Vestar Inc.(NASDAQ:VSTR) since 1989, and Amphocil, a similar agentdeveloped by Liposome Technology Inc. (NASDAQ:LTIZ), wasapproved in the United Kingdom in August 1993. Baker saidthe therapeutic and chemical profile of ABLC is distinct fromthese agents.
TLC is also enrolling patients for a Phase I/II multicenter trialof TLC C-53, a liposomal prostaglandin under development forthe treatment of acute respiratory distress syndrome (ARDS).The 24-patient trial will essentially be a dose-optimizationstudy.
TLC's stock was up 38 cents a share on Tuesday, closing at$7.50.