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R-Tech Ueno: Termination of License Agreements for Unoprostone

2015年05月07日 AM11:19
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TOKYO

R-Tech Ueno (JASDAQ: 4573)

R-Tech Ueno, Ltd. (RTU) today announced it has signed a termination agreement with Sucampo AG (SAG), one of the subsidiaries of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (Sucampo), which terminates, effective May 6, 2015, all license agreements for unoprostone.

(1) Background and Outlines

1) We entered into, on April 23th, 2009, Unoprostone NDA Transfer, Patent and Know-how Licensing, and Data Sharing Agreement, as well as Exclusive Manufacturing and Supply Agreement, with Sucampo Pharma Americas, Inc. (subsequently succeeded by SAG) for Unoprostone (Rescula®) eyedrop products for Glaucoma and Ocular Hypertension indications for countries of the United States and Canada. (Refer to our press release dated April 24th, 2009.)

2) We entered into, on March 22th, 2011, Exclusive License Agreement with Sucampo Manufacturing & Research AG (subsequently succeeded by SAG) to develop, manufacture, and commercialize Unoprostone in all countries excluding Japan, the People’s Republic of China, Taiwan, Republic of Korea and North America (United States and Canada). (Refer to our press lease dated March 22th, 2011.)

3) Sucampo, as a result of changing their business strategies, made the decision (regarding which, refer to Sucampo’s press release dated March 9th, 2015), and we agreed, to terminate the agreements. Upon termination, all rights which had been granted to SAG in relation to Unoprostone reverted to, and certain other associated assets owned by SAG were acquired by, RTU. We are expecting, under a new framework, to maximize our operating revenue by pursuing development, manufacture and commercialization of Unoprostone, including expanding indications.

(2) About the contracting party

SAG is one of the wholly-owned subsidiaries of Sucampo.

(3) Effect on our performance

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.

The President of RTU, Yukihiko Mashima, MD, PhD, an ophthalmologist, made the following statements: “Our marketing and development of Unoprostone has been limited to Japan, Korea, Taiwan and China, with other countries around the globe being in the hands of SAG, as our licensee. As a result of the termination of the agreements with SAG, RTU now solely owns and controls all associated rights on a global basis. With the United States NDA for Rescula ophthalmic solution acquired from SAG, we will, in furtherance of the achievements we have made to date in marketing and promotion in Japan, again take an aggressive approach to overseas markets under our global strategies. We will restructure our development strategies on a global basis in relation to the ophthalmic solution currently being developed by us in Japan for the treatment of retinitis pigmentosa, regarding which, please refer to our press release dated March 9th, 2015, taking advantage of the orphan drug designations in the United States and EU acquired from SAG. Further, our acquisition from SAG of patents for the treatment of AMD will enable us to take the initiative to develop, on a global basis, pharmaceutical products to treat geographic atrophy (failing vision) that develops after anti-VEGF treatment, regarding which please refer to our press release dated April 7th, 2014. We now have a chance to develop in Japan new treatments for these two unmet medical needs around the globe. Also included in the assets acquired from SAG are certain patents for the treatment of asthenopia. We will study development of new ophthalmic drugs for relief of stress.

Rescula® eye drops (0.12% Unoprostone), developed by Dr. Ryuji Ueno, MD, PhD, PhD who is a founder of R-Tech Ueno, have been on the Japanese market for 20 years due to efficacy and safe issue. R-Tech Ueno regards a characteristic of safe Unoprostone profile, and will challenge to expand indications of Unoprostone for unmet medical needs with developing new formulations as a life-cycle management.”

For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/150507_pr_en.pdf

CONTACT

R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business
Management Department
info@rtueno.co.jp

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