Bio-Technology General Corp. said Friday that it received exclusivemarketing rights for most of the world to three anti-cancer drugswhose chemical equivalents have a combined market of more than$500 million.The deal is with Shenzhen Boda Natural Product Co. Ltd. ofShenzhen, China, and covers the chemical equivalents of Taxol(paclitaxel) and VePesid (etoposide), marketed in the U.S. by Bristol-Myers Squibb Co., and doxorubicin, marketed by at least fourcompanies, primarily Pharmacia Inc. under the name Adriamycin.Bio-Technology General (BTG), based in Iselin, N.J., has exclusiverights to sell the drugs in North America, Europe and the Pacific Rim,and non-exclusive rights in China. Shenzhen Boda already is sellingetoposide and doxorubicin in Latin America and will retain rightsthere, Sim Fass, president and CEO of BTG, told BioWorld."This is one of those bonanza opportunities that come your way andhopefully can change your fate," Fass said. "We see this as a uniqueopportunity at a time when the biotech industry is going through thewringer."BTG will be responsible for gaining regulatory approvals and securingcommercial outlets. Shenzhen Boda will sell the products to BTG andget undisclosed royalties.BTG initially will focus on gaining quick approval in Thailand,Indonesia, the Philippines and Taiwan, where approval applicationsare expected to be submitted by the end of the year. "We expectapproval could be forthcoming in those countries in six to ninemonths," Fass said, "so we could be selling in those Pacific Rimcountries by the end of 1995."He said BTG probably would seek a major pharmaceutical partnerinterested in distributing the products in Europe. Fass said it will bedetermined later how to proceed in the U.S., whether to file for genericequivalency or if clinical work will be needed. Fass said ShenzhenBoda already has submitted drug master files in the U.S. for etoposideand doxorubicin."We believe Shenzhen Boda has the capacity to manufacture up to 100kilograms per year of paclitaxel" from yew trees, Fass said, addingthat is the equivalent of 3.3 million doses, which have been selling at$300 per dose. He said the Shenzhen Boda has access to yew tressthrough the Chinese government.Fass wouldn't reveal the pricing strategy other than that it "would bevery competitive to what is being sold today."BTG benefited from the relationships its special consultant, JackKantor, has with those in high levels of the Chinese government. "Theopportunity was given to Mr. Kantor to find the appropriateconnections," Fass said. "Through him we fortunately benefited."Fass said Shenzhen Boda manufactures 48 different anti-cancer drugs,and BTG plans to add others to the distribution agreement. The plan isfor BTG, which has four drugs approved in various markets and justreported its second profitable quarter, to use the early revenue from thePacific Rim sales to help fund approval attempts elsewhere, and for therevenue to help fund genetically engineered and other products BTGcurrently has in development.Paclitaxel, or Taxol, is approved in the U.S. to treat metastatic ovarianand metastatic breast cancers, and is being tested in other cancers.Etoposide usually is used in combination with other drugs to treatvarious cancers. BTG estimated both paclitaxel and etoposide haveworldwide markets of $250 million, while doxorubicin, used incombination with other chemotherapeutic agents, has a market ofmore than $100 million. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.