The Liposome Company Inc., gained an expanded indicationMonday from the FDA for its intravenous antifungal drug Abelcet.The drug _ amphotericin B complexed with two lipids _ may nowbe marketed as a treatment for a host of sometimes fatal fungalinfections in patients who fail to respond to standard amphotericin Bor those who cannot tolerate the drug.
"We are very pleased to have gotten this broadening of indication,"said Brooks Boveroux, vice president of investor relations forLiposome in Princeton, N.J. "We are also pleased that the FDAresponded so quickly."
In November 1995, the company gained approval to market Abelcetas a treatment for the fungal infection aspergillosis in patientsrefractory or intolerant to amphotericin B. Aspergillosis usuallyoccurs in people who have compromised immune systems caused bycancer, transplants, and AIDS. Aspergillosis has a 90 percent fatalityrate.
Abelcet combats these infections by allowing doctors to administerlarger doses. The lipids complexed to the amphotericin B sequesterthe drug in an inactive state. When Abelcet reaches an area ofinfection or inflammation, enzymes known as phospholipases cleavethe lipids away from the amphotericin B allowing it to become activeat specific infection sites. As a result, the Abelcet does not damagethe kidneys which is one of the major toxicities of ordinaryamphotericin B.
Abelcet, however, is an expensive treatment running approximately$500 per day or nearly 10 times the cost of amphotericin B.Nevertheless, Liposome sold more than $18 million of Abelcet in theU.S. in its first six months on the market.
In April, the company submitted a request to expand the drug'sindication to include all types of invasive fungal infections refractoryto amphotericin B. The request included invasive candida infectionswhich represent 70 percent of all invasive fungal infections.
Abelcet has been approved in the U.K., Iceland, Spain, Portugal,Sweden, Greece, Cyprus, Luxembourg, Finland and Ireland.
Marc Ostro, managing director and senior biotech analyst with UnionBank of Switzerland, projected that The Liposome Company willearn $54 million worldwide in 1996, $122.8 million in 1997 and$174 million in 1998 from Abelcet. Ostro sees a bright future forLiposome.
"Sequus Pharmaceuticals Inc. [of Menlo Park, Calif.] will likely havea liposomal antifungal on the market soon," Ostro said. "However, itwill only be approved in aspergillosis and will be competing with aproduct that has been entrenched in the market for a year with abroader labeling."
Liposome's stock (NASDAQ:LIPO) closed at $21.437 up $0.687 onthe news. n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.