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).