NeXstar Pharmaceuticals Inc. received approval in theU.K. of DaunoXome, a liposomal form of thechemotherapeutic, daunorubicin, for AIDS-relatedadvanced Kaposi's sarcoma.
Despite the U.K. approval, NeXstar's stock(NASDAQ:NXTR) dropped 9 percent Monday, closing at$12.13, down $1.25.
NeXstar officials have been conducting their road showin connection with the sale of 3 million common shares.When the Boulder, Colo.-based company registered withthe Securities and Exchange Commission in Septemberfor the stock offering, NeXstar was trading at $15. Theequity financing, in part, is targeted to support the U.S.launch of DaunoXome.
In July, NeXstar received an approvable letter from theFDA for the drug, the first liposome-based product toreach that advanced stage in the U.S. regulatory process.An approvable letter usually is the last step prior toreceiving market clearance.
Joe Alper, NeXstar's director of corporatecommunications, said the FDA inspected the company'smanufacturing facility in September and NeXstar is in theprocess of answering some routine questions posed by theagency. The company expects an approval in both theU.S. and Canada in December or January.
The U.S. market for DaunoXome, Alper said, is about$50 million to $60 million a year.
The approval in Great Britain is the second forDaunoXome in Europe, where total sales are estimated atabout $30 million per year. Sweden was first to approvethe drug in June. DaunoXome is expected to be on themarket in the U.K. by November.
NeXstar also has filed for approval in France and 11 othercountries in Europe. Alper said the U.K., France andGermany are expected to account for most ofDaunoXome's European sales.
Liposomes are considered safer than using thechemotherapy drug alone. NeXstar's liposome is acombination of a phospholipid and cholesterol. It isdesigned to concentrate the anti-cancer drug in the area ofthe tumor and keep the chemical agent in the patient'ssystem longer.
NeXstar sells another liposome product, Ambisome, inEurope. Ambisome is a liposomal form of the antifungalagent, amphotericin B. The drug is in Phase III trials inthe U.S. and is being developed in a collaboration withJapan-based Fujisawa USA Inc. n
-- Charles Craig
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