For Immediate Release

2016.02.10

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/

Daiichi Sankyo Joint Development Product Designated Under 'SAKIGAKE Designation System'

TOKYO, Japan (February 10, 2016) - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the oncolytic virus therapy for cancer (G47Δ) jointly developed with Dr. Tomoki Todo, a professor at the University of Tokyo's Institute of Medical Science (hereafter, Professor Todo), has been designated under the SAKIGAKE Designation System for medical equipment and in vitro diagnostic pharmaceuticals and regenerative medicine products, which was launched this year.

Professor Todo initiated the GCP based second-phase G47Δ clinical trial targeting glioblastoma in 2015. G47Δ has performed well in the study, and non-clinical researches and clinical researches for other carcinomas have already begun. Based on data obtained thus far, it has also been suggested that there is a possibility of expanding indications to other types of cancer. In the future, Daiichi Sankyo intends to collaborate with Professor Todo on the further development of this cancer treatment method.

Daiichi Sankyo remains committed to meeting the needs of more patients and medical professionals through drug development and contributing to medical care by providing new treatment options.

1 G47Δcancer treatment characteristics

G47Δ is the third generation of the detoxification gene recombinant herpes simplex virus type I, designed to grow only in cancer cells. Use of this new advanced cancer treatment method (hereafter, the treatment) may fundamentally alter the system of cancer treatment. Several oncolytic virus therapies are currently being developed. However, this oncolytic virus therapy has already shown far superior safety and efficacy in non-clinical researches and clinical researches.

2 SAKIGAKE Designation System

SAKIGAKE Designation System is a core policy of the 'Strategy of SAKIGAKE ' (compiled by the Ministry of Health, Labour and Welfare in June, 2014) aimed at early introduction of innovative medicines, medical devices, etc. that are initially developed in Japan. The system's objective is to designate drugs with prominent effectiveness against serious and life-threatening diseases in order to provide them to patients in Japan ahead of the rest of the world. Drugs are designated at a comparatively early stage of development and are given priority for clinical trial consultation and review. The system is being carried out on a trial basis this year.

3 Targeted disease

Glioma are primary brain tumors arising from glia cells, which are the supporting tissue for nerve cells, and the reason for their development is yet unknown. In the aforementioned clinical trials undertaken by Professor Todo, the most malignant glioblastoma within glioma are targeted. It is estimated that about 1,000 people annually in Japan suffer from glioblastoma. When subjected to standard therapies, glioblastoma show a high rate of recurrence and an extremely poor prognosis. Since most patients die within five years and there are no established treatments, this cancer is a highly unmet medical need.

Daiichi Sankyo Co. Ltd. issued this content on 10 February 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 10 February 2016 06:07:10 UTC

Original Document: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006404.html