TOKYO--(BUSINESS WIRE)--R-Tech Ueno, Ltd. (RTU) (JASDAQ:4573) today announced that RTU and Sucampo Manufacturing and Research AG (SMR), a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) (Sucampo), executed a License Agreement to develop, manufacture, and commercialize Unoprostone (Rescula®) in regions excluding Japan, Taiwan, Republic of Korea, the People's Republic of China and North America (the SMR territory).
(1) Background to this Agreement
Upon termination of our License
Agreement with Novartis Pharma AG (refer to the
press release dated July 2nd, 2010), we had sought for a
new licensee to maximize business profit from Unoprostone, and signed
this Agreement.
(2) Overview of the Agreement
Under the terms of this license
agreement, SMR holds exclusive rights to develop, use, make, have made,
export, commercialize, promote, offer for sale and sell Unoprostone in
all countries except in SMR Territory for its approved indication, the
treatment of glaucoma and ocular hypertension. Also under this
agreement, SMR has gained the right to develop Unoprostone for
additional ophthalmic indications as well as rights to all associated
patents and other intellectual property associated with Unoprostone in
SMR territory.
RTU receives an upfront payment of 3 million US
dollars from SMR upon execution of the agreement. RTU will also receive
additional milestone payments based on the achievement of specified
development and commercialization goals.
(3) About the contracting party
SMR is a wholly-owned subsidiary of
Sucampo Pharmaceuticals, Inc.
(4) Effect on our performance
We believe the above Agreement will
not bring effect on our full-year performance forecast released on
August 12th, 2010.
The President of RTU, Yukihiko Mashima, M.D., PhD, said, "In April 2009 we have already licensed the rights for the commercialization of Unoprostone in the North America region to Sucampo, which aims to market Unoprostone as a treatment for atrophic age-related macular degeneration. We are very pleased that this agreement with Sucampo, with its thorough knowledge of Unoprostone, will further enhance Unoprostone value beyond Glaucoma and Ocular Hypertension. We are focused on the development of new drugs for unmet medical needs, and we believe that Unoprostone will contribute to the Quality of Life (QOL) of a wide population of patients."
The Chief Executive Officer and Chairman of Sucampo, Dr. Ryuji Ueno, M.D., Ph.D., Ph.D. , said, "We are very excited about this agreement, as we believe that unoprostone isopropyl has significant potential in several markets. It is already approved in the United States, Japan and some European countries as a treatment for Glaucoma and Ocular Hypertension. We will move forward to reactivate the licenses in Switzerland and the European Union for Glaucoma and Ocular Hypertension as we continue our efforts to achieve a scientifically accurate and updated supplemental new drug application label in the U.S. We will, at the same time, pursue additional indications such as dry AMD and Retinitis Pigmentosa. Unoprostone isopropyl has shown new potential in Retinitis Pigmentosa patients in an RTU-sponsored trial that showed a dose-dependent improvement in retinal sensitivity after only six months of treatment. This alliance insures state of the art global development and commercialization between the Sucampo family of companies and R-Tech Ueno for all current and potential indications. If unoprostone isopropyl is successfully developed for these additional indications, it will increase our ability to fulfill our mission of offering significant new therapeutic options to ophthalmology patients."
About R-Tech Ueno, Ltd.
R-Tech Ueno is a bio venture company established in September 1989 for
the purpose of R&D and marketing of drugs. Under 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
pharmaceutical products through the eyes of doctors and selling." We are
promoting development of new drugs of unmet medical needs (medical needs
that are not fulfilled yet) which the government recommends and assists,
orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).
About Unoprostone
Rescula®(Unoprostone) Eye Drops 0.12% was developed by RTU,
and is the world's first prostone-based treatment for glaucoma and
ocular hypertension. Rescula® Eye Drops 0.12% has a
pharmacological effect as an ion channel opener. There are reports that
Rescula® Eye Drops 0.12% has not only an ocular pressure
decreasing action but also an optic nerve protective action (in vitro)
and an action to improve ocular blood flow in normal tension glaucoma.
It has been approved in 45 countries all over the world since it was
marketed in 1994. In 2009, due to formulation change, the concentration
of the preservative (benzalkonium chloride) which is reported to cause
various adverse reactions has been greatly reduced using our unique
technique.
RTU is promoting the development of a neuroprotective
drug based on Unoprostone (product name Ocuseva TM) Eye drop
0.15%, and a phase II clinical trial was completed. The results of the
phase II clinical trial showed that the product significantly reduced
the number of patients with deteriorating retinal sensitivity in the
central part of the ocular fundus.
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.
About Age-related Macular Degeneration
More than 8 million people are affected by age-related macular degeneration (AMD) in the U.S. AMD is a disease that affects the retina, leading to vision loss. AMD is the No.1 cause of vision loss in adults worldwide. It is estimated that the prevalence in the U.S. will increase by more than 50% by 2020, and that the number of patients will amount to approximately 12 million. Approximately 80 to 90% of the patients have an atrophic form of AMD, for which there is no approved treatment at present.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an international pharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body by enzymic, 15-PGDH, transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development and a member of the Board of Directors. For more information about Sucampo Pharmaceuticals, please visit www.sucampo.com.