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Alnylam Announces Grant of New Patent Covering RNAi Therapeutics in the United Kingdom

- New Woppmann et al. Patent Broadly Covers Design Features and Chemical Modifications of Small Interfering RNAs (siRNAs)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 28, 2008--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United Kingdom Patent Office has granted a patent (UK 2417727 or "'727 patent") for the Woppmann et al. patent series, entitled "Double-stranded ribonucleic acid with increased effectiveness in an organism." The newly granted patent includes 32 claims broadly covering compositions and methods, including pharmaceutical compositions, for small interfering RNAs (siRNAs), the molecules that mediate RNAi. The claims cover siRNA molecules of any length that contain "overhang" and "blunt end" design features, including siRNAs containing chemical modifications and certain novel motifs.

"Our intellectual property estate for RNAi therapeutics continues to grow substantially as evidenced by this new patent grant, the first in a distinct patent series that describes important design features for RNAi therapeutics. With this progress, we are extending the scope of our comprehensive 'first-mover' consolidation of early filed RNAi fundamental patents and patent applications," said Barry Greene, President and Chief Operating Officer of Alnylam. "We expect that many additional patents owned or licensed exclusively to Alnylam will be awarded this year and in the years to come, broadening the sphere of our patent portfolio for siRNAs in markets across the world."

"This first grant of the Woppmannet al. patent covers a broad range of design features, including 'overhangs,' 'blunt ends,' and certain nucleotide motifs, that may be important for optimizing siRNAs for pharmaceutical uses," commented Donna Ward, Ph.D., Vice President of Intellectual Property of Alnylam. "We look forward to the continued examination of this patent in other territories."

The claims for the '727 patent cover compositions and methods for siRNAs, including, in general terms:

    --  a double-stranded RNA of any length having effectiveness in
        inhibiting a target gene by RNAi;

    --  with "overhang" and "blunt-end" design features and certain
        nucleotide pair motifs;

    --  with or without chemical modifications, with no limitations as
        to the number of such modifications;

    --  including pharmaceutical compositions of the claimed siRNAs
        for inhibiting the expression of a target gene by means of
        RNAi; and/or,

    --  methods for the selection of such an siRNA molecule or methods
        for inhibiting the expression of a target gene in a cell.

The claims of the Woppmann et al. '727 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 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)
        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 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 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

    --  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 Patent No. 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;

    --  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 patents and patent
        applications covering inventions by 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, and Roche. 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

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 expected 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.

CONTACT: Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207
Yates Public Relations
Kathryn Morris, 845-635-9828

SOURCE: Alnylam Pharmaceuticals, Inc.