Alnylam Grants Quark License to Develop and Commercialize RNAi Therapeutic Products
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Alnylam Pharmaceuticals, Inc. has announced that it has granted Quark Biotech, Inc.™ licenses to discover, develop, and commercialize RNAi therapeutics targeting the p53 and RTP801 genes for certain diseases.
Quark has filed investigational new drug (IND) applications for RNAi therapeutics for both targets, in the case of p53 for the treatment of renal failure, and in the case of RTP801 for the treatment of ocular diseases, specifically macular degeneration.
Simultaneously, Quark has agreed to withdraw its support of opposition to the Kreutzer-Limmer patent series currently granted in Europe.
"We are very pleased to provide Quark with a license to Alnylam intellectual property for its innovative RNAi therapeutic programs," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam.
"With these two licenses, we have now granted six InterfeRx licenses to date, and 12 licenses in total for therapeutic RNAi applications."
"With the recent strengthening of our patent estate, we expect that companies working in the area of RNAi therapeutics will continue to seek licenses to our intellectual property."
"In fact, we anticipate that into next year, a significant number of clinical-stage RNAi therapeutic programs will be licensed under Alnylam intellectual property."
"RNAi therapeutics represent a promising approach as a new class of drugs for unmet medical needs wherever the disease targets are otherwise practically un-druggable with today’s medicines," said Dr. Daniel Zurr, Chief Executive Officer of Quark.
"Quark’s creative way to discover new targets and concepts for treatment of devastating diseases, combined with an RNAi approach, have yielded very encouraging early results with our p53 and RTP801 drugs."
"We are dedicated to help society with innovative medicines by moving from novel gene targets to unique compounds and eventually commercial products."
"In our comprehensive review of the intellectual property landscape for the commercialization of RNAi therapeutics, it was clear that a license to Alnylam patents is required for these exciting programs, and we’re pleased to have access to these assets."
Alnylam has built a portfolio of issued or granted patents in the world’s major pharmaceutical markets that claim fundamental features for all RNAi therapeutics, including the structural and functional properties of synthetic RNAi therapeutic products.
The recognized potential of RNAi to provide the basis for a class of drugs to treat a broad range of human diseases has created a high level of interest among biopharmaceutical companies in gaining access to this intellectual property.
Alnylam created the InterfeRx licensing program to grant licenses under this intellectual property to biotechnology and pharmaceutical companies wishing to pursue RNAi therapeutics against specific targets outside Alnylam’s core strategic interests.
In addition to Quark, Alnylam’s InterfeRx licensees include Calando Pharmaceuticals, Nastech Pharmaceutical Company, GeneCare Research Institute Co., and, under an option agreement, Benitec Ltd.
Quark’s RNAi therapeutic that targets p53 is being developed to reduce tubular damage and preserve kidney function.
The concept of the temporary and reversible inhibition of p53 to prevent apoptosis in normal cells following ischemia-reperfusion injury was first described by Quark in 1999 in the journal Science and is covered by broad issued U.S. patents.
Extensive animal studies have shown that the drug protects the animals from ischemia/reperfusion-induced acute kidney injury.
Quark’s second RNAi therapeutic targets the gene RTP801. Quark reported the discovery of RTP801 in 2002 and was granted several U.S. patents covering the gene, its encoded protein and their inhibition to treat serious diseases.
The inhibition of the RTP801 target has been shown to have beneficial effect in a number of oxidative (hypoxic) injury–related disease models.
Extensive animal studies have shown that the drug protects the animals from the three hallmarks of macular degeneration: retinal neuronal death, blood vessel regeneration, and vascular leakiness.
