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TMCNet:  R-Tech Ueno: Adoption of the Unoprostone Ophthalmic Solution in the 3rd A-STEP Public Recruitment in FY2012

[February 01, 2013]

R-Tech Ueno: Adoption of the Unoprostone Ophthalmic Solution in the 3rd A-STEP Public Recruitment in FY2012

TOKYO --(Business Wire)--

R-Tech Ueno (JASDAQ:4573) is pleased to announce that the unoprostone (development code: UF-021) ophthalmic solution currently in development as a treatment of retinitis pigmentosa Note 1 (product name: OcusevaTM) has been adopted in the Adaptable and Seamless Technology Transfer Program through Target (News - Alert)-Driven R&D (A-STEP) public recruitment as "Full-scale R&D Stage - Practical Application Type (Contract Development) Note 2" by the Japan Science and Technology Agency (JST) and that we have concluded an agreement on new technology contract development, etc. with JST today.
Approved project in the FY2012 third public recruitment (JST website):
http://www.jst.go.jp/a-step/kadai/h24-3honkaku.html

The UF-021 ophthalmic solution adopted in this program is a new prescription ophthalmic solution containing isopropyl unoprostone as the active ingredient which R-Tech Ueno has been developing as a treatment of retinitis pigmentosa. Retinitis pigmentosa is a serious inherited condition designated as an intractable disease causing impaired visual function and leading to visual loss, for which no effective treatment has been established yet. The UF-021 ophthalmic solution prevents vision impairment and vision loss by improving retinal sensitivity of the central retina through the protection of the cones, a type of the photoreceptors, and its safety and efficacy have been already confirmed in phase I and II clinical trials. In this development program, R-Tech Ueno will conduct phase III clinical trials to verify its efficacy, aiming to provide a treatment of retinitis pigmentosa in clinical practice.

This adoption will have no impact on the forecast of business results for the fiscal year ending March 2013.

With regard to this adoption, the President of R-Tech Ueno, Yukihiko Mashima, MD., PhD. commented, "We are very pleased that the UF-021 ophthalmic solution has been adopted in A-STEP as Full-scale R&D Stage - Practical Application Type (Contract Development) by the JST. I have seen and treated many patients with retinitis pigmentosa as an ophthalmologist; however, no effective treatment has been established yet for this intractable disease, retinitis pigmentosa. R-Tech Ueno, a pharmaceutical venture business, is ver proud of being able to get national support for the development of a treatment of this intractable disease. We plan to conduct phase III clinical trials to verify the efficacy and safety of the UF-021 ophthalmic solution. Once approval has been obtained, the ophthalmic solution will be the world's first treatment of retinitis pigmentosa developed and produced in Japan. Seeking for approval, we are now preparing for the first phase III clinical trial in Japan in this spring. We continue our efforts to seek for early approval for the treatment of retinitis pigmentosa aiming to improve quality of life of patients with the disease."


(note1) About Retinitis Pigmentosa

Retinitis pigmentosa is a hereditary disease and its prevalence rate is said to be about 1 in 5000 people in the world and 1 in 4000 - 8000 people in Japan. When this number is applied to the population of Japan, 128 million people, the number of patients with retinitis pigmentosa can be estimated as 16,000 - 32,000 people which makes this disease an orphan disease. On the other hand, when projecting the number of patients with retinitis pigmentosa in the world from the world population, 6.75 billion people (2008), it can be estimated as 1.35 million people. When retinitis pigmentosa progresses, patients suffer progressive night blindness, where it becomes difficult to see in dim light, or visual field constriction and then deterioration of vision. In the end stage, they may suffer from severe visual loss or even blindness. It is designated as an intractable disease and appropriate therapeutic drugs or therapeutic methods have not been established at the moment. According to the report by the "Research Study Group Regarding Retinochoroidal and Optic Atrophy", a specified disease treatment research program of the Ministry of Health, Labour and Welfare (MHLW) in 2005, retinitis pigmentosa is the 3rd cause for impaired vision and especially in patients aged 60 or under it is the leading cause for impaired vision.

Accreditation of Retinitis Pigmentosa as a Specified Disease
Some diseases are very difficult to treat, they chronically develop, leave after-effects and make it extremely difficult or impossible for the patient to return to society, require a high medical cost, cause a heavy burden both domestically and mentally such as financial problems and nursing care and furthermore, as they are rare diseases they need to be studied on a nationwide scale. MHLW designates such diseases as intractable diseases. Currently, 130 diseases are designated as intractable diseases. Retinitis pigmentosa is a research target of the clinical research study area of the Research for Overcoming Intractable Diseases, MHLW. Disease number 33. Additionally, among the 130 intractable diseases, 56 are accredited as "specified diseases" and receive public fund assistance for medical expenses. Retinitis pigmentosa is one of the "specified diseases" and is covered by public fund assistance for medical expenses. Diseases subsidized for medical expenses of designated intractable diseases: disease number 37.
Reference: Japan Intractable Disease Information Center www.nanbyou.or.jp/sikkan/114_i.htm

(Note 2) A-STEP "Practical Application Type (Contract Development)"

A-STEP is a technology transfer support program for the R&D phase to aim at practical application of research results created at universities and public research institutions. This program provides a participating institution with a total R&D funding of up to 2 billion yen for up to 7 years. If the development is successful, the participating institution repays the total amount of the provided funding by paying royalties based on product sales. If the development is not successful, the participating institution repays 10% of the provided funding.
Reference: A-STEP www.jst.go.jp/pr/info/info912/sankou1.html

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 CEO, also a medical doctor, the company is developing new drugs on the theme "Physician-Oriented New Drug Innovation", targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent.
We aim at becoming a "global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and developing and selling pharmaceutical products through the eyes of doctors." We are promoting the development of new drugs for unmet medical needs for which the government provides recommendations and assistance, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).


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