TOKYO, Japan I December 2, 2019 I Gene Techno Science Co., Ltd. (“GTS”) resolved at the board of directors meeting held on today to execute an agreement for joint development of Aflibercept Biosimilars with Kishi Kasei Co., Ltd. (“Kishi Kasei”) for a commercialization of this product.

1. Purpose and background for concluding this agreement

This agreement aims to secure a future revenue base through the commercialization of this biosimilar product, establish a solid financial base, and gain market share in the field of ophthalmologic diseases.

Aflibercept (product name: Eylea) is marketed as a treatment for age-related macular degeneration in Japan, and the market size is estimated at about 60 billion Japanese yen. As announced on May 14, 2013 by “Joint Research Agreement with Fuso Pharmaceutical Industries (“Fuso Pharmaceutical”) for a High-producing Cell Line for Biopharmaceutical Products”, this biosimilar product is a high-yield protein producing cell lines that was developed through the joint research, and is considered to secure future competitive advantage by reducing manufacturing costs with it high- yield productivity.

Kishi Kasei has the technology and know-how accumulated through the manufacturing and sale of colors for use in foods, cosmetics, medicines, and clinical testing reagents etc. By taking this advantages, Kishi Kasei has been developing and manufacturing drug substances for biological medicines, and achieved high track record. We believe Kishi Kasei is the best partner to build the manufacturing system of the drug substances for this biosimilar product.

Under this development agreement, we will establish a manufacturing process for the drug substance using high-yield protein producing cell lines. In parallel, we will search for a partner to jointly promote drug development, non-clinical studies, clinical studies, manufacturing and marketing approvals, sales, etc., and build business structure for a commercialization of this biosimilar product.

2. Contents of this agreement

Joint development agreement for a series of developments toward the commercialization of this biosimilar product using Aflibercept biosimilar producing cell line jointly developed with Fuso Pharmaceutical.

3. Outline of counterparties to this agreement (as of March 31, 2019)

1.         Company Name Kishi Kasei Co., Ltd.
2.         Name and title of representatives Executive Director     Taimei Kase
Executive Director     Daisuke Maezawa
3.         Established May, 1953
4.         Head Office 1-10-8 Fukuura, Kanazawa-ku, Yokohama-shi, Japan
5.         Main Business Manufacture and marketing of colors for use in foods, cosmetics, medicines, and consumer products; clinical testing reagents and other acidic dyestuffs.
6.         Capital 40,000 thousand Japanese Yen

4. Future outlook

The impact on the business results for the fiscal year ending March 2020 is expected to be minimal.

About Gene Techno Science Co., Ltd.

GTS announced GTS 3.0 “Biotech Engineering Company, striving for value creation” a new business stage starting from this fiscal year, which targeted the pediatric disease in addition to the areas GTS has been engaged in such as the orphan disease and intractable disease. By leveraging the knowhow and expertise about biotechnology acquired in the past business activities, GTS is working on the development and provision of new medicines and therapeutic treatment for the purpose of achieving comprehensive healthcare solutions for the patients suffering from these diseases as well as families and caregivers.

SOURCE: Gene Techno Science Co