Isis and Alnylam Announce Issued U.S. Patent Broadly Covering Chemical Modifications of Oligonucleotide Therapeutics
Monday November 27, 8:00 am ET
New Patent Covers Oligonucleotide Compositions with Chemical Modifications to Improve Potency, Stability, and Selectivity
CARLSBAD, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Isis Pharmaceuticals, Inc. (Nasdaq: ISIS - News) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News) announced today that a key patent was issued by the United States Patent and Trademark Office (USPTO). The U.S. patent (U.S. Patent No. 7,138,517 or " '517 patent") broadly covers certain chemical modifications of oligonucleotides used to introduce "drug-like" properties in antisense oligonucleotides, including small interfering RNAs (siRNAs), the molecules that mediate RNA interference (RNAi). The issued patent is owned by Isis and is licensed exclusively to Alnylam for double-stranded RNAi therapeutic applications pursuant to the terms of their 2004 collaboration and license agreement.
"Our intellectual property estate continues to yield issued patents stemming from our pioneering efforts in the discovery and development of RNA-based therapies, including RNAi and other antisense mechanisms," said C. Frank Bennett, Ph.D., Senior Vice President, Research for Isis. "This new patent is particularly important for the emerging field of RNAi therapeutics, where our strategic alliance with Alnylam has aligned our intellectual property assets with what we believe is the leading company in the field."
"We deeply value our relationship with Isis and recognize the significance of their early contributions to and continued leadership in the field of oligonucleotide therapeutics. Indeed, our alliance with Isis represents a key component of Alnylam's overall patent estate for the development and commercialization of RNAi therapeutics," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam. "This newly issued patent broadly covers certain chemical modifications that are used to improve potency, stability, and selectivity of siRNAs, including so-called 'no-ribose' or 'siNA' derivatives."
The new '517 patent stems from the Cook patent series that includes three previously issued U.S. patents (U.S. Patent Nos. 5,670,633; 6,005,087; and 6,531,584), and its claims broadly cover oligonucleotide compositions containing more than one 2'-ribose modifications such as 2'-O-methyl and 2'-fluoro groups. These chemical modifications can be used to improve potency and stability of siRNAs (Journal of Medicinal Chemistry 2005, 48, 901-904) and can also be used to optimize their selectivity.
About Isis Intellectual Property (IP) Licensed to Alnylam for RNAi Therapeutics
Isis Pharmaceuticals, Inc. controls more than 150 issued patents pertaining to chemical modification of oligonucleotides for therapeutic applications. These patents have been exclusively licensed to Alnylam for double-stranded RNAi therapeutics and include, but are not limited to:
The Crooke Patents: U.S. 5,898,031 and U.S. 6,107,094 cover compositions, methods, and uses of modified oligonucleotides to inactivate a target mRNA mediated by a double-stranded RNase;
Phosphorothioate and 2'-O-methyl modifications (Buhr, U.S. Patent No. 6,476,205); and,
2'-Ribose modifications (Cook, U.S. Patent Nos. 5,670,633; 6,005,087; 6,531,584; and 7,138,517).
About Alnylam Intellectual Property (IP)
Alnylam's IP estate includes issued or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of synthetic RNAi therapeutic products. As it applies to the U.S. and Europe, these include:
The Tuschl II '704 patent (U.S. Patent No. 7,056,704) issued in June 2006 and exclusively licensed to Alnylam, which broadly covers methods of making siRNAs to silence any and all disease targets;
The Tuschl II '196 patent (U.S. Patent No. 7,078,196) issued in July 2006 and exclusively licensed to Alnylam, which broadly covers methods of making siRNAs with or without chemical modifications;
The Kreutzer-Limmer I '623 patent (EP 1144623) granted in August 2002, upheld in June 2006 and owned by Alnylam, covering methods, medicaments, and uses of siRNAs having, among other structural features, a length of 15-21 base pairs;
The Kreutzer-Limmer I '945 patent (EP 1214945) granted in June 2005 and owned by Alnylam, covering compositions, methods, and uses of siRNAs with a length between 15 and 49 nucleotides;
Additional fundamental patents and patent applications licensed to Alnylam on an exclusive or non-exclusive basis, including those of Fire and Mello (U.S. Patent No. 6,506,559) and Glover et al. (EP 1230375); and,
Several divisional patent applications pending of the aforementioned issued or granted patents and additional patent applications pending including Tuschl I.
About RNA Interference (RNAi)
RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause highly targeted gene silencing.
About Isis Pharmaceuticals, Inc.
Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 14 drugs in development. Isis' drug development programs are aimed at treating cardiovascular, metabolic and inflammatory diseases. Isis' partners are focused in disease areas such as ocular, viral and neurodegenerative diseases, and cancer. In its Ibis Biosciences(TM) division, Isis is developing and commercializing the Ibis T5000(TM) Biosensor System, a revolutionary system to identify infectious organisms. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of approximately 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.
About Alnylam
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is building a pipeline of RNAi therapeutics; its lead program is in Phase I human clinical trials for the treatment of respiratory syncytial virus (RSV) infection, which is the leading cause of hospitalization in infants in the U.S. The company's leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, and Biogen Idec. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts, and has an additional operating unit in Kulmbach, Germany. Alnylam is honored to be the "emerging/mid-cap" company recipient of the 2006 James D. Watson Helix Award, the biotechnology industry's award for outstanding achievement. For more information, visit www.alnylam.com. |
