Eisai To Market U.K.'s Biocompatibles' Drug-Eluting Beads In Japan; Dips Toes In Device R&D; Risk

 Full story reprinted from PharmAsia News - July 30, 2009

TOKYO - In a rare arrangement for a Japanese pharma, Eisai said July 28 it signed a licensing agreement with Biocompatibles International to develop and market the U.K. company's drug-eluting bead products DC Bead and Precision Bead in Japan. Read more...

 Eisai To Market U.K.'s Biocompatibles' Drug-Eluting Beads In Japan; Dips Toes In Device R&D Risk

 Full story reprinted from PharmAsia News - July 30, 2009 

TOKYO - In a rare arrangement for a Japanese pharma, Eisai said July 28 it signed a licensing agreement with Biocompatibles International to develop and market the U.K. company's drug-eluting bead products DC Bead and Precision Bead in Japan. Eisai spokesman Tadaharu Mitsui told PharmAsia News Japanese drug makers in principle are not interested in entering the device industry since they are reluctant to have the added risk of device development. Eisai will have the first right of refusal for related products, which use polyvinyl alcohol hydrogel microspheres for sustained release of chemotherapy drugs. Mitsui said DC Bead, most commonly loaded with doxorubicin for treatment of hepatocellular carcinoma, was recommended by Japan's Ministry of Health, Labor and Welfare as a priority medical device in January 2009 and that MHLW safety approval as well as Chuikyo's decision about National Health Insurance pricing are expected soon. Mitsui said the agreement is in line with the company's oncology focus, and Eisai has no particular ambition of expanding into the device arena. Biocompatibles International will receive an initial £3 million ($4.9 million), followed by possible milestone payments and royalties on net sales. The option agreement was originally announced in May 2008, but Eisai chose not to exercise its option until it established the regulatory requirements for DC Bead. Because of MHLW's priority approval, Eisai is only required to conduct a "limited safety study in Japanese patients," Biocompatibles said. DC Bead is currently marketed in over 35 countries, and is used as an embolization material during vascular embolization of malignant hypervascularized tumors. Precision Bead is a drug-eluting bead loaded with doxorubicin. Biocompatibles estimates there are roughly 40,000 new cases of HCC in Japan each year - compared to 15,000 new cases in the U.S. each year - and HCC is the third-highest cause of cancer death in Japan. Once MHLW approval is given, Eisai will explore using the beads for additional indications, Mitsui said. - Toshio Aritake

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