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Alnylam Announces Grant of Broad Patent Covering RNAi Therapeutics in Germany

Monday, November 26, 2007

New Patent in Kreutzer-Limmer Series Covers Compositions and Uses of siRNAs with a Length of 15 to 49 Nucleotides

Cambridge, MA -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the German Patent Office has granted a patent (DE 10080167 or "’167 patent") for the Kreutzer-Limmer I patent series. The newly granted patent includes 52 claims broadly covering medicaments comprising small interfering RNAs (siRNAs), the molecules that mediate RNAi, as well as medical uses of siRNAs. The covered siRNAs are 15 to 49 nucleotide pairs in length. The new Kreutzer-Limmer patent extends the worldwide scope for issued claims covering siRNA technology to Germany, the largest national pharmaceutical market of the European Union (EU).

The patent series has been licensed to Alnylam’s four pharmaceutical collaboration partners, seven biotechnology companies in Alnylam’s InterfeRx™ program, and 15 companies in the research reagent and services market. The patent is enforceable in Germany against potential infringers using the patented technology without an Alnylam license.

"Our intellectual property estate for RNAi therapeutics remains unparalleled in the industry, and represents an important component of our efforts to bring our innovative medicines to patients," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam. "Importantly, the newly granted ’167 patent covers a broad scope of medicaments containing siRNA structures having a length of 15 to 49 nucleotides which includes the so-called ‘blunt end’ or ‘dicer substrate’ design with or without chemical modifications, as well as other possible features."

"The Kreutzer-Limmer patent series is an early patent in the RNAi field that Alnylam acquired in 2003 through its merger with Ribopharma AG. The patent stems from research performed by the inventors in 1999, representing some of the earliest work on siRNAs," commented Donna Ward, Ph.D., Vice President of Intellectual Property of Alnylam. "Alnylam’s intellectual property estate includes multiple issued, exclusively held patents that relate to the early and fundamental discoveries of RNAi including our Crooke, Kreutzer-Limmer, and Tuschl II patent series that together have been issued in over 15 countries across the world, including the U.S. and EU."

The claims for the ’167 patent cover pharmaceutical compositions and uses of double-stranded RNAs having key elements that are widely recognized as important for the therapeutic activity of siRNAs, including, in general terms:

  • a double stranded RNA with a length of 15 to 49 base pairs;
  • pharmaceutical compositions or uses of such siRNAs to inhibit the expression of mammalian target genes, where such genes are oncogenes, cytokine genes, developmental genes, or infectious disease genes;
  • chemical modifications, with no limitations, to provide stabilization from degradation; and/or,
  • formulations, including liposomes, and modifications, including conjugates, to enable delivery.

The claims of the Kreutzer-Limmer ’167 patent are provided on the company’s website, together with claims from other Alnylam owned or licensed patents.

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 synthetic RNAi therapeutic products. As it applies to the U.S. and EU, these include:

  • the Crooke Patents (U.S. Patent Nos. 5,898,031 and 6,107,094) 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 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 July 2007 and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers compositions, methods, and uses of siRNAs;
  • the Kreutzer-Limmer I ’623 patent (EP 1144623) granted in August 2002, maintained in amended form in June 2006 and owned by Alnylam, covering 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, covering 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, covering pharmaceutical compositions and uses of siRNAs with a length between 15 and 49 nucleotides that target certain broad categories of mammalian genes;
  • 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 (EP 1230375); and,
  • many divisional patent applications pending of the aforementioned issued or granted patents and additional patent applications pending including Tuschl I.

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., covering chemical 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); and,
  • 2’-Ribose modifications of oligonucleotides (Cook, U.S. Patent Nos. 5,670,633; 6,005,087; 6,531,584; and 7,138,517).

In addition to fundamental and chemistry patents, Alnylam is 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 influenza, hypercholesterolemia, and liver cancers, among other diseases. 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, and Roche. The company, founded in 2002, maintains headquarters in Cambridge, Massachusetts. For more information, visit

Alnylam Forward-Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including its views with respect to the timing and the future issuance of patents and the importance and scope of its intellectual property rights, 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 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.

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