Nitto Denko to use its specialty delivery vehicle, targeting technology for fibrosis with novel therapeutic concepts together with Quark proprietary RNAi technology, novel structures with FTO and siRNA clinical development expertise to file for an IND for a new anti-fibrotic drug

Nitto Denko Corporation, Japan's leading diversified materials manufacturer and Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced the initiation of a collaboration and license agreement for the development of siRNA therapeutics for the treatment of fibrotic diseases.

The collaboration is designed to develop siRNA drugs using Quark's RNAi technologies and novel structures providing freedom to operate in the siRNA intellectual property space and Nitto Denko's drug delivery technologies for novel therapeutic concepts, currently owned by Nitto Denko. This refers to the concepts developed in a groundbreaking research by Prof. Yoshiro Niitsu of Sapporo Medical University, School of Medicine, Sapporo, as published in Nature Biotechnology Vol. 26 Issue 4 Pg. 431-42 (Apr 2008).

The collaboration will have an initial budget of double-digit million US dollars to achieve the first IND at the US FDA by early 2012.

"We are very pleased to collaborate with Nitto Denko in developing siRNA drugs. This collaboration is a perfect marriage between the core competencies of the two companies; we shall be using our technologies, intellectual property and capabilities to quickly bring drug candidates to clinical stage and Nitto will provide its delivery technologies and therapeutic strategy as well as their world class capabilities in oligonucleotide production," said Daniel Zurr, Ph.D., Quark's CEO.

Mr. Kageshi Maruyama, Nitto Denko's Officer, commented: "We are delighted to initiate this siRNA program. We believe siRNA is going to make a very important impact to the field of pharmaceuticals discovery and development. With its production facilities and extensive research, Nitto Denko is geared to have a very active participation in this market. We are pleased to work with Quark, we selected Quark due to the superior characteristics of its siRNA structure and chemical modifications, distinguished for the fact that have caused no immune response and look forward to utilizing this technology to create innovative medicines."

"I am very confident that siRNA drugs directed simultaneously to one or more specific target genes are the appropriate approach for therapies for a number of fibrotic diseases that are currently a totally unmet medical need," commented Prof. Niitsu. "Our research has demonstrated that the adequate siRNA, appropriately delivered to the liver caused regression of liver fibrosis and significantly prolonged survival time in siRNA treated animals. It is very likely that this approach is suitable to fibrotic diseases in other organs as well."

About Nitto Denko

Nitto Denko Corporation is Japan's leading diversified materials manufacturer with total sales of over 600 billion yen. In the field of life sciences, Nitto is a major world supplier of polymeric formulations for drug delivery and of solid support for siRNA synthesis. Nitto has a leading market share of the amidite block, the major raw material for siRNA manufacture and has recently announced the launch of its next-generation high-loading polymeric solid support product "NittoPhase®HL" for oligonucleotide synthesis, the latest development to the unparalleled polymer synthesis and R&D capabilities of Nitto Denko. Nitto Denko biotechnology research focuses on gene and drug delivery, tissue engineering, imaging and other related technologies.

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc., the world leader in novel RNAi discovery and development, has the largest clinical-stage siRNA pipeline in the industry. The Company's fully integrated drug development platform spans therapeutic target identification to drug development. Quark's approach to delivery allows targeting of tissues and organs including the eye, kidney, ear, lung, spinal cord and brain.

Quark's pipeline is led by PF-04523655, currently in two Phase II clinical trials for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). In 2006 the siRNA therapeutic candidate was licensed to Pfizer, who is conducting both trials in collaboration with Quark. PF-04523655 targets Quark's proprietary gene, RTP801, discovered using its BiFAR™ target discovery platform that identifies clinically relevant critical genes and proteins that reverse the disease phenotype when inhibited. The Company owns a family of patents covering the RTP801 gene, its RNA and protein product sequences, specific antibodies, and gene inhibition across different pathologies.

Quark is also evaluating QPI-1002, the first systemically administered siRNA drug in human clinical trials. Enrollment was successfully completed in Phase I studies of QPI-1002 for the prevention of acute kidney injury (AKI) following major cardiovascular surgery and the prophylaxis of delayed graft function (DGF) after kidney transplantation and Phase II clinical studies are planned to commence shortly. For the structure of these products, Quark has obtained licenses from Silence Therapeutics and from Alnylam Pharmaceuticals.

Quark is currently conducting clinical trials of QPI-1007, its proprietary synthetic siRNA drug candidate for ocular neuroprotection. QPI-1007 utilizes a proprietary structure developed in collaboration with BioSpring GmbH that provides Quark with freedom to operate in the siRNA intellectual property arena and chemical modifications that are designed to preserve RNAi activity while ameliorating potential off-target and immunostimulatory effects of siRNAs.

Quark is also committed to leveraging a broad research pipeline of siRNA drug candidates and novel siRNA structures to develop additional RNAi drug candidates.

Contact:
Quark Pharmaceuticals, Inc.
Juliana Friedman
+972 89 30 5111
jfriedman@quarkpharma.com

The Ruth Group (investors / media)
Sara Pellegrino / Jason Rando
(646) 536-7002 / 7025
spellegrino@theruthgroup.com
jrando@theruthgroup.com

Source: Quark Pharmaceuticals, Inc.

Press Releases

Nitto Denko and Quark Pharmaceuticals to Enter Into Collaboration to Develop a Novel siRNA Anti-fibrotic Drug

Osaka, Japan Jul 15, 2010

Osaka, Japan
Jul 15, 2010