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Press Release 2010


Strategic Collaboration Targeting an IND filing of Anti-Fibrosis Drug

Nitto Denko Takes Another Step Forward in siRNA Drug Development

Japan’s leading diversified materials manufacturer Nitto Denko Corporation (Nitto Denko) has taken another step forward toward commercializing its small interfering RNA (siRNA) technology, by entering into a collaboration agreement with Quark Pharmaceuticals, Inc. (Quark) of the U.S., Nitto Denko announced today. 
Headquartered in Fremont, California, Quark is one of the world’s leading siRNA drug development companies specializing in discovering and developing novel RNA interference (RNAi)-based therapeutics. 
Aiming at commercializing a novel drug delivery technology and therapeutic concept developed by Prof. Yoshiro Niitsu of Sapporo Medical University, Japan, for treatment of the fibrosis of organs such as liver cirrhosis, Nitto Denko has conducted joint development work with Prof. Niitsu and his team since 2008, and so far achieved certain results such as verifying the therapeutic effect and clarification of the therapeutic mechanism. 
It is with such a backdrop that Nitto Denko has entered into the agreement with Quark concerning the development of therapeutic drugs for treating fibrotic diseases such as liver cirrhosis, in order to push ahead with the endeavors toward attaining the clinical trial stage. 
More specifically, based on combining Quark’s expert know-how with Nitto Denko’s proprietary drug delivery technology as well as therapeutic concepts for fibrosis, the company aims at filing with the U.S. Food and Drug Administration an Investigational New Drug(IND)application -- the application to begin the clinical trials -- for a novel anti-fibrosis drug by the summer of 2012. 
With the collaboration of Quark who is rich in expertise, Nitto Denko will accelerate its joint development work with Prof. Niitsu, in order to realize the swift commercialization of the therapies for the benefit of millions of fibrosis patients around the world.

Background of Technical Development

With a strong track record in transdermal drug delivery technology, Nitto Denko holds the world’s top-level market shares in bronchodilator skin patches for treating asthma and angina treatment patches. And having added to its Medical-related business a company called Aveva Drug Delivery Systems (formerly Elan Transdermal Technologies), a transdermal drug delivery patch manufacturer located in Miramar, Florida, in 2003, Nitto Denko is actively engaged in the manufacture and sale of transdermal drug delivery patches in the U.S. 
The collaboration with Quark this time will enable Nitto Denko to promote the development of a novel therapeutic drug with a safe and optimal design. Nitto Denko will realize that goal by combining the drug delivery system developed based on its extensive biomaterial research applying its expertise in chemistry, on the one hand, and by incorporating Quark’s siRNA-based drug development capability into the fibrosis therapy first published by Prof. Niitsu and his team, on the other hand. Too, this latest development effort is expected to result in a new core technology of the company’s medical business in the future.

About Quark Pharmaceuticals, Inc.

Headquarters: Fremont, California, U.S.
Established: 1993
Employees: Approximately 100
Business: Quark Pharmaceuticals, Inc is one of the world’s leading pharmaceutical companies specializing in discovering and developing novel siRNA drug development since the 2000’s. With a rich stock of symptoms-related DNA information concerning a wide range of diseases which the company has been accumulating since its establishment, Quark now processes in the pipeline five drugs in the clinical trial stage, including the therapeutics for treating wet age-related macular degeneration, diabetic macular edema and acute renal failure.

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