SciClone Pharmaceuticals Inc. is entering the Japanese marketfor hepatitis B and C with corporate partner Schering-PloughCorp. (NYSE:SGP).
SciClone Pharmaceuticals International Ltd. signed a long-term,semi-exclusive licensing agreement with Schering-Plough K.K.for the development and commercialization of thymosin alpha1 in Japan.
Schering-Plough developed alpha-interferon in Japan, ThomasMoore, SciClone's chief executive officer and chairman, saidfrom his San Mateo, Calif., office on Wednesday, and can usethe channels it has established there to develop thymosin alpha1.
Schering-Plough K.K. will develop, register and marketthymosin 1 alpha in Japan in return for paying SciClone initialand milestone payments and buying bulk drug substance fromSciClone. Contingent upon successful research and developmentresults, development costs and payments to SciClone couldreach $35 million.
SciClone is seeking a second partner in Japan that wouldprobably provide as much or more money and may work withSchering-Plough and SciClone on clinical trials, marketing andinvestigation of other indications, such as cancer adjuvant orimmune suppression situations, Moore told BioWorld.
Japanese pharmaceutical regulations require registering a drugfor one indication and taking it through an approval processbefore registering for another indication on the same drug. Thesecond partner might register the same drug under a differentbrand name for a different indication, he said.
Once approved, pharmaceuticals in Japan have seven yearsmarketing exclusivity, he added, and so using a second partnerfor another indication could help secure broader exclusivemarketing.
Treatment with alpha interferon requires initial hospitalization,he continued. Thymosin alpha 1 would probably be pricedsimilarly to alpha interferon, but treatment doesn't requirehospitalization. Thymosin alpha 1 has been shown in U.S.clinical trials to be effective in halting the progression ofchronic active hepatitis B disease and returning liver functionto normal in approximately 75 percent of patients, withvirtually no reported side effects.
Schering-Plough K.K. will purchase all product from a SciClonebusiness unit and will have access to ownership of newdevelopments in Japan, while SciClone will hold all rightsoutside the U.S. and Europe, where about 90 percent of theworld's hepatitis cases occur.
Hepatitis is a major problem in Japan, with an estimated 3million hepatitis B and C carriers. Alpha interferon is the onlyapproved treatment, Moore said, with sales of more than $1billion -- about $360 million of that going to Schering-Plough.
SciClone (NASDAQ:SCLN) expects to conclude clinical trials inTaiwan and Mexico this year, and has subsidiaries in Japan,Taiwan and Singapore, which is the regional office formarketing to eight other countries in Asia.
SciClone's stock was up 88 cents a share on Wednesday, closingat $20.25.
-- Nancy Garcia Associate Editor
(c) 1997 American Health Consultants. All rights reserved.