NeXstar Pharmaceuticals Inc. got a jump on competitors Friday withthe signing of a development and marketing agreement forAmBisome in Japan with Sumitomo Pharmaceuticals Co. Ltd.
NeXstar already has approval for the liposomal form of the antifungalagent amphotericin B in 25 countries, and plans to file a new drugapplication in the U.S. in October.
The Boulder, Colo., company received a $7 million licensing feefrom Sumitomo and will receive another $3 million upon the filing ofan investigational new drug application in Japan and $4 million uponapproval there. Additionally, NeXstar will get 30 percent of sales inJapan, which includes its manufacturing payments, said Joseph Alper,NeXstar's corporate communications director.
NeXstar will provide product to Sumitomo and access to its data, butthe Osaka, Japan-based company will cover all development andmarketing costs in Japan.
NeXstar stock (NASDAQ:NXTR) gained 63 cents Friday to close at$20.75 after reaching $21.88 earlier in the day.
AmBisome is under development in the U.S. and Canada withFujisawa USA, of Deerfield, Ill., a subsidiary of another Osakacompany, Fujisawa Pharmaceutical Co. Ltd.
Alper said, "Sumitomo really wanted this drug and we really wantedto work with them. Sumitomo felt this fit into its portfolio of drugs inJapan.
"We're encouraged about our prospects in Asia," Alper said. "I thinkit has been an under-appreciated [antifungals] market, partly becausethere's not much amphotericin sold. But it's not sold because it's sotoxic. Asian prescribing practices look down on those kinds ofdrugs."
The U.S. filing is expected to be a broad one, covering first- andsecond-line treatments for confirmed and suspected fungal infectionsin a variety of patient populations. Through six months of 1996AmBisome sales were $36.7 million.
Sumitomo President Masayasu Tekeuchi, in a prepared statement,said, "After carefully reviewing each of the liposomal and lipid-basedpreparations of amphotericin B, we decided that AmBisome was theonly one of these drugs that met the efficacy and safety requirementsof Japanese physicians."
Alper said there has been some use of AmBisome by Asianphysicians. University of Tokyo physicians will present data frompatients with invasive aspergillosis at an upcoming meeting of theJapan Society of Clinical Hematology.
NeXstar is selling AmBisome itself in most countries where it'sapproved. The company has "demonstrated we know how to sell thisdrug" and does not intend to seek additional partnerships, except,perhaps, in some other Asian countries, Alper said.
In June NeXstar, caught up in a down biotechnology market,withdrew a 2.5 million share offering. The company, which had $50million in cash on June 30, didn't really need the money, Alper said,adding that this deal strengthens its cash position further. "We plan tobreak even on an operating basis next quarter and be profitable fromthen on," he said. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.