April 27, 2015 To those concerned R-Tech Ueno, Ltd. (JASDAQ・Code4573) Head Office: 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo Representative: Yukihiko Mashima,Representative Director & President Contact: Koji Nakamura, Business Management Department TEL: 03-(3596) 8011 Announcement on Acquisition of the Right to Develop and Commercialize DE-105 from Santen Pharmaceutical Co., Ltd. This is to announce that R-Tech Ueno, Ltd. (Head Office: Chiyoda-ku, Tokyo, CEO and President: Yukihiko Mashima, hereinafter referred to as "R-Tech Ueno") today has acquired the right to develop and commercialize DE-105 (*Note 1) from Santen Pharmaceutical Co., Ltd. (Head Office: Kita-ku, Osaka, CEO and President: Akira Kurokawa, hereinafter referred to as "Santen"). DE-105 is a treatment targeting at persistent corneal epithelial defects (*Note 2) that Santen has been developing. By acquisition of this right, R-Tech Ueno undertakes development of this agent towards commercialization going forward. Moreover, we have also concluded an agreement with the inventor of DE-105, Professor Emeritus Teruo Nishida (Graduate School of Medicine,Yamaguchi University) (*Note 3) to invite him as medical advisor of R-Tech Ueno. This arrangement enables us to promote development taking advantage of our strength; collaboration between industry and academia. Our president Yukihiko Mashima, MD & PhD, who is also an ophthalmologist, made the following comments. "DE-105 is an ophthalmic solution of neurotrophic factor peptide, discovered and developed from academia. It has been developed as a treatment for severe persistent corneal epithelial defects caused by corneal sensory nerve disorder (currently at the stage of Phase I clinical trial in the United States and Phase II clinical trial in Japan). Damage to corneal sensory nerves causes various corneal and conjunctival epithelial disorders (persistent corneal epithelial defects, post-LASIK corneal epithelial defects, severe dry eye, disorder associated with decreased corneal sensitivity caused by long-term contact lens wear, etc.); however, treatment utilizing existing ophthalmic solutions have not been satisfying treatments so far. Going forward, we will develop this agent as a curative treatment for various corneal and conjunctival epithelial disorders targeting at not only persistent corneal epithelial defects but also other diseases. The subject of acquisition this time not only includes the patents of DE-105 application in the fields of ophthalmology, dermatology, gastrointestinal medicine but also the right of development overseas as well as in Japan. In the U.S, Phase I clinical trial has already been completed, and we plan to actively undertake global development in collaboration with Professor Emeritus Teruo Nishida, who is the inventor of DE-105 and a global prominent clinical scientist. Potential effects of this arrangement on our business performance are minimal. Nevertheless, we will reflect such in the full-year earnings forecast for the fiscal year ending March 31, 2016. End. (*Note 1) DE-105 With its effect to repair the corneal epithelial defects by extension promoting action of corneal epithelial cells and its safety, DE-105 is expected to cure persistent corneal epithelial defects that is intractable by existing treatment. With such expectation, Santen has completed Phase I clinical trials in the United States and Phase II clinical trials in Japan. This ophthalmic solution is a neurotrophic factor peptide formulation that Professor Emeritus Teruo Nishida at Yamaguchi University Graduate School of Medicine (Ophthalmology) has invented. (*Note 2) persistent corneal epithelial defects A condition where the corneal epithelial defects is persistent for some reasons. Epithelial defects are usually determined to be persistent if not cured for a week or longer. The state of epithelial defects bears the risk of infection at any time. Persistent defects may cause melting of parenchyma of cornea and may exacerbate to corneal ulcer. Furthermore, if chronicity or severity is advanced, it may lead to corneal perforation or endophthalmitis. Accordingly, epithelium needs to be re-covered at an early stage (epithelial defects repair). There are various diseases that cause persistent corneal epithelial defects. Most of such diseases are corneal nerve defects; however, there are other diseases such as autoimmune disorder (arthritis), corneal epithelial stem cell deficiency, corneal epithelial dystrophy, and allergic diseases (atopic dermatitis, vernal conjunctivitis), etc. (*Note 3) Professor Emeritus Teruo Nishida at Yamaguchi University Professor Teruo Nishida (Professor Emeritus , Yamaguchi University) graduated Osaka University School of Medicine in 1971. He successsively held the positions at the Institute for Protein Research at Osaka University, Ophthalmology Assistant at Osaka University School of Medicine, Ophthalmology Lecturer at Kinki University School of Medicine. Thereafter in October 1993, he was appointed as a professor of Ophthalmology at Yamaguchi University Graduate School of Medicine. After his retirement as a professor in 2010, he served as Trustee/Vice President of Yamaguchi University (national university corporation), and he is currently Professor Emeritus of the same university. He has been commited to study on treatment of ectocornea injury over years, and his study on conglutinant effect of fibronectin for ectocornea injury was recognized as pioneer study. Thereafter, he proceeded with fundamental research of physiological effects of neurogenic factor in corneal epithelium, and the clinical study of nerve paralysis keratopathy of intractable diseases. As a result of such study, he discovered neurotransmitter substance P and insulin-like growth factor-1, both of which have the corneal epithelium promoting activity. His discovery paved a path for clinical application of intractable corneal epithelial disease therapeutics. In 2001, he was granted Castroviejo Medal (The Cornea Society, the U.S.), an award given to one researcher in the world every year, who made outstandingly significant achievement in the field of cornea. He is the second Japanese researcher who won this award. Furthermore, he has received many other national and international prizes including Western Japan Culture Prize in 2002 (Nishinippon Shimbun: Western Japan Newspaper), Alcon Research Institute Annual Award (ALCON Research Institute, USA) in 2004, Peter Halberg Lecture (International Medical Contact Lens Council, the United States) in 2006, the Japanese Ophthalmological Society Award (Japanese Ophthalmological Society) and Medical Award of the Japan Medical Association (Japan Medical Association) in 2007, Chugoku RegionCulture Award (Chugoku Shimbun: Chugoku Region Newspaper) in 2008, and Saiichi Mishima Award (Asia Cornea Society, Singapore) in 2012. · About R-Tech Ueno R-Tech Ueno is a bio venture company established in September 1989 for the purpose of R&D and marketing of drugs. Under the leadership of the President Mashima, who is also a medical doctor, the company is developing new drugs along with the theme “Physician-Oriented New Drug Innovation”, targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent. We aim to become a “global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) that develops and markets pharmaceutical products from doctors' point of view.” We are promoting the development of new drugs for unmet medical needs for which the government recommends and provides assistance such as orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).
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