R-Tech Ueno: Basic Agreement on the Licensing of Data of Recombinant Human Serum Albumin

TOKYO--(BUSINESS WIRE)-- R-Tech Ueno (JASDAQ:4573) and the Chemo-Sero-Therapeutic Research Institute (hereinafter referred to as Kaketsuken) reached basic agreement today on the licensing of data of recombinant human serum albumin as described below:

(1) Background
R-Tech Ueno on October 18th, 2011 reached basic agreement to have supply of recombinant human serum albumin (R-Tech Ueno development code: RU-101) from Novozymes Biopharma DK A/S (hereinafter referred to as Novozymes) in order to restart soon the development of the ophthalmic solution for the treatment of dry eye.

This recombinant human serum albumin is manufactured and supplied exclusively by Kaketsuken at Kikuchi-shi, Kumamoto, Japan, which is Novozymes' partner supplier.

R-Tech Ueno and Kaketsuken now reached basic agreement today on the licensing of data including safety data of recombinant human serum albumin that is required for the development of the ophthalmic solution for the treatment of dry eye.

This basic agreement enables us to promote the interrupted development of the ophthalmic solution for the treatment of dry eye, and it is planned to actively prepare for clinical trials in the United States.

(2) Contract summary
Based on this basic agreement, R-Tech Ueno is licensed by Kaketsuken to use the data including safety data of recombinant human albumin in the marketing application of the ophthalmic solution for the treatment of dry eye.


(3) Profile of partner

Name   The Chemo-Sero-Therapeutic Research Institute
Address 1-6-1 Okubo, Kumamoto-shi, Kumamoto, Japan
Name of representative Akinobu Funatsu (Director General)
Description of business Research, development, manufacture and supply of biological drugs including vaccines and plasma derivatives
Sales   33.7 billion yen

* Sales is as of the end of March 2011.


(4) Impact on business performance
The contract does not require amendment of the earnings forecast for the first two quarters (accumulated and full-year) released on May 13, 2011.

Yukihiko Mashima, President of R-tech Ueno, says: "I am very pleased that we have the agreement with Kaketsuken on the licensing of data. Kaketsuken is acknowledged for the research and development of vaccines and plasma derivatives, and is a reliable business partner in the promotion of the development of a therapeutic agent for moderate or severe dry eye, which is our major pipeline. We are going to make the most of the data to be supplied by Kaketsuken, preparing for the initiation of clinical trials in the United States as soon as possible, focusing on speedy marketing approval for dry eye patients."

About RU-101
RU-101 is a project that is aimed at the development of ophthalmic solutions for the treatment of corneal epithelial diseases including dry eye, focusing on serum component albumin. Dry eye is a chronic and multifactor ophthalmic disease characterized by disorders of the lacrimal layer and the eye surface. R-Tech Ueno has confirmed that serum albumin enhances the production of mucin, one of the components of tears, in an experiment in conjunctival epithelial cells, and also has intellectual property rights concerning the treatment of dry eye with albumin.

About R-Tech Ueno, Ltd.
R-Tech Ueno, Ltd. is a drug discovery venture company. It was established in September 1989 for the purpose of R&D, manufacturing and selling of drugs and offering R&D assistance services.
Under the leadership of the President, Yukihiko Mashima, who is also a medical doctor, the company aims at "becoming a global pharmaceutical company specializing in specific fields and developing and selling pharmaceutical products through the eyes of doctors" under the theme of "Physician-Oriented New Drug Innovation."
Targeting ophthalmologic and dermatologic diseases for which there has been no effective therapeutic agent, R-Tech Ueno is promoting development of new drugs in the fields of unmet medical needs, orphan drugs and anti-aging drugs (lifestyle drugs), which the government recommends and supports.

About Kaketsuken
Kaketsuken was established in 1945 and has been contributed to the fields of prevention and treatment of infectious diseases in and outside Japan via the development and supply of biological drugs including vaccines and blood products. At present, Kaketsuken produces a wide variety of plasma derivatives, vaccines for human use and for animal use and antitoxins, and conducts research and development for the development of new products including biotechnology products.
Moreover, the plant in which recombinant albumin is manufactured was completed in 2005 (first phase construction), and recombinant albumin is supplied via Novozymes to be used such as in drug stabilizers and media.


R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Business Management Department
[email protected]

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