September 25, 2024
SBI Pharma Co., Ltd.

SBI Pharma Co., Ltd. (Location: Minato-ku, Tokyo; President and CEO: Yoshitaka Kitao; hereafter, “SBI Pharma”), a subsidiary of SBI Holdings Co., Ltd., which is a subsidiary of SBI Holdings Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President: Hitoshi Shiomura; hereinafter “Nobel Pharma”), is a photodynamic diagnostic agent for malignant glioma “Arabel Internal Use Agent”) I would like to inform you that approval for manufacturing and sales of “1.5g” (hereafter “Arabel”) in Japan will be carried over as of 10/1.

In Japan, Nobel Pharma conducted clinical trials as a joint project with SBI Pharma, and manufacturing and sales approval was obtained in 2013/3. Recently, Photonamic GmbH & Co., a subsidiary of the developer SBI Holdings Based on an agreement with KG (headquarters: Pinneberg, Germany, representative: Ulrich Kosciessa, Ph.D., hereinafter “Photonic”), it was decided to inherit manufacturing and sales approval. Furthermore, after succession, SBI Pharma will promote proper use and carry out sales promotions as the manufacturer and seller.

Due to this succession of manufacturing and sales approvals, SBI Pharma has decided to centrally handle intraoperative diagnostic agents using 5-ALA in Japan along with “Alaglio Granule Package 1.5g” and “Alaglio Internal Use 1.5g” (seller: Nippon Kayaku Co., Ltd.) (*2), which are intraoperative diagnostic agents for bladder cancer that have undergone recent usage changes.

Going forward, SBI Pharma will continue to make efforts to contribute to everyone's health and prosperity every day, and will continue to make further efforts so that more patients and health care workers working on cancer treatment can make beneficial use of Arabell.

■About Arabel Internal Use 1.5g
Arabel is a photodynamic diagnostic agent (generic name: aminolevulinic acid hydrochloride) used during removal surgery for malignant glioma, which is a type of brain tumor, and is sold worldwide in over 45 countries around the world, including Europe and the United States, through partners from Photonamic.
In Japan, clinical trials were conducted as a joint project between SBI Pharma and Nobel Pharma, and the efficacy and safety of dissolving Arabel in tumor removal surgery for malignant glioma was confirmed by dissolving it in water 3 hours (range: 2 to 4 hours) before introduction of anesthesia during surgery, and shining a specific wavelength of light on the affected area during surgery to make the tumor area glow red, making it easy to identify with normal tissue.

■About glioma (shin kei koshu)
Gliomas are glial cell tumors located in the brain, and most of them are malignant tumors with poor prognosis. Gliomas account for approximately 30% of primary brain tumors and are classified into several types based on the morphology of the cells that make up tumors. Among them, astrocytoma is the most common, and it can be broadly divided into 4 stages (grade I to IV) depending on the degree of malignancy. Grade IV in particular is called glioblastoma and is the most malignant tumor with an extremely poor prognosis. Surgical surgery (craniotomy) is usually performed as a standard treatment for glioma, but it is difficult to remove all tumors by surgery, and in many cases radiation therapy or chemotherapy is performed after surgery.

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