British Biotech plc signed a potential $74 million licensingagreement with Tanabe Seiyaku Co. Ltd. to develop and marketmarimastat, British Biotech's oral anti-cancer drug, in Japan.
Tanabe will pay British Biotech $7 million up front. The remaining$67 million will be paid in milestone payments linked todevelopment of the drug.
Tanabe, of Osaka, Japan, will finance development costs, includingall clinical trials and registration. In return for exclusive marketingrights in Japan, Tanabe agreed to a revenue-sharing arrangement thatpays a percentage of sales to British Biotech, of Oxford, U.K. BritishBiotech will supply the materials and will retain marketing rights tomarimastat across North America and Europe.
Katie Arbor, head of corporate communications for British Biotech,told BioWorld Today her company didn't think it was appropriate atthis stage of its development to set up a product development andmarketing operation in Japan. "However, it is a very importantmarket for us and we have been negotiating with several Japanesepharmaceutical companies," she said.
"Tanabe is the 8th largest pharmaceutical company in Japan," Arboradded. "Its modern success has been built on the cardiovascular drug,Cardizem, which is sold worldwide. It is still the world's 18th bestselling drug."
In 1996, Tanabe has signed agreements with Signal PharmaceuticalsInc., of San Diego; Lynx Therapeutics Inc., of Hayward, Calif.;Centocor Inc., of Malvern, Pa.; and Pharmacia & Upjohn, ofKalamazoo, Mich.
Tanabe's track record of taking drugs through development in Japan,Arbor said, was another attractive feature for British Biotech. "Youcan't submit American data in Japan and get the drug registered onthe back of that," she pointed out. "The way to go is to work with aJapanese company that is familiar with the system."
The agreement also specifies that Tanabe be given the right of firstrefusal to negotiate rights to develop and market marimastat in Asiancountries outside of Japan.
Marimastat is a broad-spectrum agent with potent inhibitory actionsagainst the known classes of matrix metalloproteinases, enzymesimplicated in breaking down tissues which surround malignanttumors. Marimastat therapy, according to the company, preventstissue breakdown and contains malignancy.
The Phase II trial program comprised a series of open-label studies indifferent types of cancer, using a 28-day treatment protocol. In someof the tumor types _ mainly ovarian, pancreatic, colorectal andprostatic cancers _ cancer specific antigens were used to monitortumor progression. The company reported the effect of marimastat inreducing the rate of rise of cancer antigens had been confirmed.
Marimastat is in North American and European Phase III trials inpancreatic cancer (400 patients), small cell lung cancer (200 patients)and glioblastoma (300 patients) and gastric (300 patients). Thesetrials will take about two years to complete.
Arbor said Tanabe will start trials in Japan in cancer patients in 1997.
British Biotech's stock (NASDAQ:BBIOY) closed Thursday, up$0.375 to $38.875. n
-- Frances Bishopp
(c) 1997 American Health Consultants. All rights reserved.