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|Alnylam Provides Update on "Glover" Patent|
CAMBRIDGE, Mass.--(BUSINESS WIRE)--July 10, 2008--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the Glover patent (EP 1230375), which is exclusively licensed to Alnylam from Cancer Research Technology Limited (CRT), has completed initial oral opposition proceedings in Europe. Through these proceedings, the Opposition Division of the European Patent Office has overturned the previously granted claims of the patent which covered certain features of RNAi therapeutics. Alnylam intends to appeal any decision which does not result in the patent being maintained in its present form or scope. The Glover patent is one of many issued or granted so-called "fundamental" patents in Alnylam's broad intellectual property (IP) estate for RNAi therapeutics.
"As is well known, the European patent process is lengthy, often involving opposition and appeal procedures that result in varied outcomes, and we consider this outcome just one step for our Glover patent. Moreover, today's ruling does not alter the significant position of Alnylam IP for developing and commercializing RNAi therapeutics, nor does it impact any of our ongoing business development discussions, as the Glover patent was only one of eleven issued or granted fundamental patents held by Alnylam," said Barry Greene, President and Chief Operating Officer of Alnylam. "Alnylam's patent estate remains unparalleled in the industry and we continue to expect that many additional patents owned or licensed exclusively to Alnylam will be awarded through the rest of this year and into the future, broadening the geographic and claim scope of our patent portfolio for all RNAi therapeutics."
About Alnylam Intellectual Property (IP)
Alnylam's IP estate includes issued, allowed, or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products. These include:
-- the Crooke Patents (U.S. Patent Nos. 5,898,031 and 6,107,094 and EP 0928290) issued in over 12 countries and licensed exclusively from Isis Pharmaceuticals, Inc. to Alnylam for RNAi therapeutics, which cover compositions, methods, and uses of modified oligonucleotides to inactivate a target mRNA mediated by a double-stranded RNase, such as "RISC," which is the cellular enzyme complex that mediates RNAi; -- the Kreutzer-Limmer I '623 patent (EP 1144623) granted in August 2002, maintained in amended form in June 2006 and owned by Alnylam, which covers methods, medicaments, and uses of siRNAs having, among other structural features, a length of 15 to 21 base pairs; -- the Kreutzer-Limmer I '945 patent (EP 1214945) granted in June 2005 and owned by Alnylam, which covers compositions, methods, and uses of siRNAs with a length between 15 and 49 nucleotides; -- the Kreutzer-Limmer I '167 patent (DE 10080167) granted in October 2007 and owned by Alnylam, which covers pharmaceutical compositions and uses of siRNAs with a length between 15 and 49 nucleotides that target certain broad categories of mammalian genes; -- the Kreutzer-Limmer I '235 patent (DE 10066235), granted in January 2008 and owned by Alnylam, which covers methods, uses, and medicaments of siRNAs, with a length between 15 and 49 nucleotides, expressed through a vector; -- the Kreutzer-Limmer II '061 patent (EP 1352061), granted in May 2006 and owned by Alnylam, which covers therapeutic compositions, methods, and uses of siRNA and derivatives directed toward over 125 disease targets; -- the Tuschl II '704 patent (U.S. Patent No. 7,056,704) issued in June 2006 and exclusively licensed to Alnylam from the Max Planck Society, 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 from the Max Planck Society, which broadly covers methods of making siRNAs with or without chemical modifications; -- the Tuschl II '044 patent (EP 1407044), granted in January 2008 and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers compositions, methods, and uses of siRNAs; -- the Tuschl II patent (JP 4 095 895) granted in May 2008 in Japan and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers compositions, methods, uses, and systems of siRNAs; and, -- many divisional and continuing patent applications pending of the aforementioned issued or granted patents and additional patent applications pending, including patents and patent applications covering inventions by Fire and Mello (U.S. Patent No. 6,506,559), Glover, Tuschl, Hannon, and Kay.
In addition to fundamental patents, Alnylam is the exclusive licensee in the field of RNAi therapeutics for more than 150 issued chemistry patents owned or controlled by Isis Pharmaceuticals, Inc. broadly covering chemical modifications, including motifs and patterns of modifications of oligonucleotides, including RNAi therapeutics. These patents include:
-- phosphorothioate and 2'-O-methyl modifications of oligonucleotides (Buhr, U.S. Patent No. 6,476,205); -- 2'-Ribose modifications of oligonucleotides (Cook, U.S. Patent Nos. 5,670,633; 6,005,087; 6,531,584; and 7,138,517); -- chemical conjugates of oligonucleotides (Manoharan, U.S. Patent No. 6,153,737); and, -- "overhang," "blunt-end," and nucleotide pairing design motifs (Woppmann et al., UK 2417727).
In addition to fundamental and chemistry patents, Alnylam is also the exclusive licensee in the field of RNAi therapeutics for certain delivery patents, including those owned and controlled by Tekmira Pharmaceuticals, Inc. covering delivery of oligonucleotides, including RNAi therapeutics, with liposomal formulations. These patents include:
-- formulations of oligonucleotides, including siRNAs, in cationic liposomes (Wheeler, U.S. Patent Nos. 5,976,567 and 6,815,432; and Semple, U.S. Patent No. 6,858,225). About RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
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 leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world's top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV) infection. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including hypercholesterolemia, liver cancers, and Huntington's disease. 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 Medtronic, Novartis, Biogen Idec, Roche, Takeda, and Kyowa Hakko Kogyo. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam has established "RNAi 2010" which includes the company's plan to significantly expand the scope of delivery solutions for RNAi therapeutics, have four or more programs in clinical development, and to form four or more new major business collaborations, all by the end of 2010. Alnylam is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA therapeutics. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, visit www.alnylam.com.
About Cancer Research Technology
Cancer Research Technology Limited (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found at www.cancertechnology.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam's future expectations, plans and prospects, including its views with respect to the expected validity, enforceability, importance and scope of its intellectual property rights, including the Glover patent, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Alnylam's approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; obtaining, maintaining and protecting intellectual property; Alnylam's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Alnylam's ability to obtain additional funding to support its business activities; Alnylam's ability to realize future milestones and royalties; Alnylam's dependence on third parties for development, manufacture, marketing, sales and distribution of products; obtaining regulatory approval for products; competition from others using technology similar to Alnylam's and others developing products for similar uses; Alnylam's dependence on collaborators; and Alnylam's short operating history; as well as those risks more fully discussed in the "Risk Factors" section of its most recent quarterly report on Form 10-Q on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.
CONTACT: Alnylam Pharmaceuticals, Inc. Cynthia Clayton, 617-551-8207 (Investors) or Yates Public Relations Kathryn Morris, 845-635-9828 (Media) SOURCE: Alnylam Pharmaceuticals, Inc.