Eisai files for Japanese approval of Biocompatibles' embolic beads
This article was originally published in Scrip
Following the exercise of an option earlier this year, Eisai has now made an approval filing in Japan for a microspheric bead product licensed from Biocompatibles International, for the treatment of hepatocellular carcinoma (HCC).
The DC Bead system (coded E7040 by Eisai) makes use of polyvinyl alcohol hydrogel particles that are injected via catheter into the hepatic artery to provide precise embolisation, blocking the arterial blood flow that feeds the tumour. The beads do not elute any drug, Eisai told Scrip.
The system has already been commercialised (including as LC Bead) in more than 40 countries, and was identified as a high-need medical therapy by Japan's ministry of health, labour and welfare in early 2009.
Eisai exercised an option for exclusive development and commercialisation rights in Japan to two of the UK firm's bead products earlier this year, in a deal that also gave it certain rights to other products in Biocompatibles' pipeline. Biocompatibles received £3 million upfront and will be paid milestones plus double-digit royalties on Eisai's eventual sales of the products (scripintelligence.com, 28 July 2009).
Given the medical need and official support for its development, together with the lack of active drug, the product looks likely to be approved relatively quickly. Consultations with the regulatory authorities had established that only a limited safety study in Japanese patients would be required, Biocompatibles has noted.
HCC has a particularly high incidence in many parts of Asia due to the levels of hepatitis infection, and affects an estimated 67,000 patients annually in Japan, where there are around 40,000 new diagnoses every year. Some 20,000 patients qualify for transcatheter arterial embolisation procedures.
Other treatments marketed for HCC in the country include Bayer Schering Pharma's oral multi-kinase inhibitor Nexavar (sorafenib), Dainippon Sumitomo Pharma's Miripla (miriplatin) and Nippon Kayaku's IA Call (cisplatin), with the latter two products both being delivered via hepatic artery injection. Pfizer's Sutent (sunitinib) is also in late local clinical development for the indication.
The UK specialty pharmaceutical company BTG last month made a £177 million bid to acquire Biocompatibles (scripintelligence.com, 19 November 2010).