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Alnylam Receives Grant of New Patent Broadly Covering RNAi Therapeutics

^{Published on 2009-02-10 05:23:02, Last Modified on 2009-02-10 05:25:33 - Market Wire}
 

CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the first grant for the Kay & McCaffrey patent. The patent is an early, "fundamental" patent in the RNAi therapeutics field based on the groundbreaking research by Drs. Anton McCaffrey and Mark Kay (McCaffrey et al. (2002) Nature418, 38-39) who were amongst the first to demonstrate the ability to harness RNA interference in a living mammal. The Kay & McCaffrey patent is licensed exclusively to Alnylam through an agreement with Stanford University.

The Kay & McCaffrey patent (AU 2002326410) was granted after examination by the Australian Patent Office with 38 claims that broadly cover methods and compositions of RNAi therapeutics, including a method of reducing expression of a coding sequence in a target mammalian cell with a double-stranded RNA of between 15 and 25 nucleotides in length. In addition, the patent includes claims covering small interfering RNAs (siRNAs, the molecules that mediate RNAi) and short hairpin RNAs. The Kay & McCaffrey patent series, with these and additional claim sets, is pending in other jurisdictions, including the U.S., EU, and Japan.

"We are delighted to add the Kay & McCaffrey patent to the broader portfolio of Alnylam held patents that comprise intellectual property (IP) which we believe is fundamental for the development and commercialization of all RNAi therapeutics," said Barry Greene, President and Chief Operating Officer of Alnylam Pharmaceuticals. "This new grant, the first for the Kay & McCaffrey series, expands the scope of our fundamental IP estate that also includes issued or granted patents from the Crooke, Kreutzer-Limmer, and Tuschl II estates. Of course, we have a clear track record of leveraging our patent portfolio to enable the field and provide freedom to operate for RNAi therapeutics, as evidenced by more than 25 licensing agreements which have yielded over $660 million in realized cash funding. With this and the continued expansion of our IP estate, we expect our business development execution to only continue in the future."

Alnylam's IP position is comprised of fundamental, chemistry and delivery, and target IP that the company believes is necessary for the development and commercialization of RNAi therapeutics. In aggregate Alnylam owns or has in-licensed over 1,800 active patent cases, of which over 700 have issued or been granted worldwide, and 317 have issued or been granted in the U.S., Europe, or Japan, the world's largest pharmaceutical markets; together, these define the company's IP estate for RNAi therapeutics. In addition to the Kay & McCaffrey patent, Alnylam's fundamental IP estate includes exclusive licenses to the Crooke, Glover, Tuschl II, and Kreutzer-Limmer patent families, as well as the Li & Kirby, Pachuk I, and Giordano patent families obtained from its acquisition of the patent assets from Nucleonics, Inc. It also includes a co-exclusive license to the Tuschl I and Hannon patent families and a non-exclusive license to the Fire & Mello patent.

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, 6,107,094, 7,432,249, 7,432,250 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 '719 patent (EP 1550719), owned by Alnylam and where the company has received a notification of ‘intent to grant', which covers siRNAs comprising 15-21 nucleotides in length stabilized by chemical linkages;
• 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;
• the Kay & McCaffrey patent (AU patent application no. 2002326410) granted in February 2009 in Australia and exclusively licensed to Alnylam from Stanford University, which broadly covers methods and composition for RNAi therapeutics including siRNAs and shRNAs; 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 & Mello (U.S. Patent No. 6,506,559), Glover, Li & Kirby, Pachuk, Tuschl, Hannon, and Giordano.

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 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), which is owned by Alnylam.

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 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 and is partnered with Cubist and Kyowa Hakko. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including liver cancers, hypercholesterolemia, Huntington's disease, and TTR amyloidosis. 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, Kyowa Hakko, and Cubist. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam established "RNAi 2010" in January 2008 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, 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, please visit [ http://www.alnylam.com ].

Alnylam Forward-Looking Statement

Various statements in this release concerning Alnylam's future expectations, plans and prospects, 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 the company's ability to successfully obtain and maintain intellectual property, including patents, covering the RNAi technology 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.