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ºÚÁÏÍø Signs License Agreement with Biocompatibles International for Drug-Eluting Bead Products for Embolisation

ºÚÁÏÍø., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “ºÚÁÏÍø”) announced today that the Company has concluded a license agreement with Biocompatibles International plc (Headquarters: Farnham, United Kingdom, CEO: Simon Crispin, “Biocompatibles”) for the development and commercialisation of Drug-Eluting Bead Products for embolisation in Japan.

Under the conditions of the agreement, ºÚÁÏÍø shall obtain the exclusive rights to develop and commercialise Polyvinyl Alcohol Hydrogel Microsphere (hereinafter, “the Product”) and its related product, developed by Biocompatibles.

The Product is a drug-eluting bead developed by Biocompatibles, which facilitates the loading and sustained release of a chemotherapeutic drug. As the beads are microscopic and uniformly spherical, most appropriately-sized particle for the targeted blood vessel to be embolised can be selected. The Product is currently marketed in more than 40 countries around the world, mainly in Europe and the United States, and is used as an embolisation material during vascular embolisation of malignant hypervascularised tumours, primarily hepatocellular carcinoma (HCC). While the Product has yet to be introduced in Japan, it was recommended at the Japanese Ministry of Health, Labour and Welfare’s Panel of experts meeting on early introduction of highly needed medical devices convened in January of this year that the Product be made available on the Japanese market in the near future.

It is estimated that the total annual number of patients with HCC in Japan is approximately 67,000, with about 40,000 people being newly diagnosed each year. Transcatheter arterial chemoembolization (TACE) is one treatment option performed on about 30 percent of patients with HCC.

ºÚÁÏÍø defines oncology as one of its most important therapeutic areas of focus. With the conclusion of this agreement, ºÚÁÏÍø will expedite the development of the Product, which is much anticipated in Japan, to contribute to the treatment of malignant hypervascularised tumours.

[Please refer to the following notes]

Contacts:

PR Department
ºÚÁÏÍø., Ltd.

81-3-3817-5120

< Notes to Editors >

Malignant Hypervascularised Tumour

A malignant hypervascularised tumour most commonly refers to hepatic cancer, renal cancer, soft -tissue osteosarcoma, and other malignant tumours that are nourished via a sophisticated vascular network developed in tumour tissue.

Embolisation

An endovascular procedure performed using angiography, in which an embolisation material is injected into the targeted blood vessel through a catheter. It is less-invasive compared to other surgical procedures. In recent years, it has become a more popular option for the treatment of malignant hypervascularised tumours and cerebral arteriovenous malformations.

In the case of malignant hypervascularised tumours, embolisation is used to cut off the blood flow and nutrient supply to the tumour in order to kill it, by embolising the blood vessel that nourishes it. While there are two kinds of therapies used in the treatment of HCC, Trans-arterial embolisation (TAE) which does not use chemotherapeutic drugs and Transcatheter arterial chemoembolisation (TACE) which does, TACE is currently most commonly performed.

Polyvinyl Alcohol Hydrogel Microsphere

A drug-eluting bead product developed by Biocompatibles, which facilitates the loading and sustained release of a chemotherapeutic drug. As the beads are microscopic and uniformly spherical, most appropriately-sized particle for the targeted blood vessel to be embolised can be selected. The Product (Brand Name in Europe: DC Bead™, Brand Name in the U.S.: LC Bead™) is currently marketed in more than 40 countries around the world, mainly in Europe and the U.S., and is used as an embolisation material during vascular embolisation of malignant hypervascularised tumours, primarily HCC.