Aug 09, 2005 Press Release for Alnylam

Alnylam Receives Allowance for Broad New European Patent Covering RNAi Therapeutics; New "Kreutzer-Limmer II" Patent Covers RNAi Therapeutics towards over 125 Disease Targets

Aug 09, 2005

Alnylam Receives Allowance for Broad New European Patent Covering RNAi Therapeutics; New "Kreutzer-Limmer II'' Patent Covers RNAi Therapeutics towards over 125 Disease Targets

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 9, 2005--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the allowance of broad claims from the European Patent Office for a new patent (EP Patent No. 1352061) covering small interfering RNAs (siRNAs), the molecules that mediate RNA interference (RNAi). The new "Kreutzer-Limmer II" patent, which Alnylam acquired in the July 2003 merger with Ribopharma AG, includes allowed claims that cover therapeutic compositions, methods, and uses of siRNAs and derivatives directed toward over 125 disease targets.

"The new Kreutzer-Limmer II patent extends Alnylam's clear leadership in fundamental and chemistry IP to the application of RNAi therapeutics toward specific disease targets," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals. "The allowance of these new claims in the world's second largest pharmaceutical market is part of the continued progress in the advancement of Alnylam's IP estate in RNAi. At the same time, this continued leadership is being recognized by others and is being translated into value today through formation of alliances and license agreements with 14 separate companies to date."

The new patent includes 103 allowed claims on therapeutic compositions, methods, and uses comprising siRNAs that are complementary to all mRNA sequences in over 125 disease target genes. These genes include targets that are part of ongoing Alnylam development and pre-clinical programs, such as those involved in the VEGF pathway and those expressed by viral pathogens including RSV and influenza virus. In addition, the claimed targets include oncogenes, cytokines, cell adhesion receptors, angiogenesis targets, apoptosis and cell cycle targets, and additional viral disease targets such as HCV and HIV.

In addition to the Kreutzer-Limmer II patent on RNAi targets, Alnylam's intellectual property estate is comprised of certain "fundamental" patents and patent applications that claim the broad structural and functional properties of synthetic RNAi products. These include the Kreutzer-Limmer I patents, also acquired through the Ribopharma merger: EP Patent No. 1144623, covering siRNAs having a sequence complementary to a target gene of up to 25 nucleotides in length; and EP Patent No. 1214945, 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 include those of Crooke (US Patent No.'s 5,898,031 and 6,107,094), Fire and Mello (US Patent No. 6,506,559), Glover et al. (EP Patent No. 1230375), Tuschl et al. ("Tuschl 1" and "Tuschl 2", patents pending), amongst others.

Alnylam has leveraged its intellectual property assets through broad R&D alliances with Merck and Co., Inc. and Medtronic, Inc., target-by-target therapeutic licenses through Alnylam's InterfeRx^™ program with Nastech, Inc., GeneCare Research Institute Co., Ltd. and Benitec Ltd., and license agreements in the research reagent and services markets with multiple companies including Invitrogen Corporation, Sigma-Aldrich Corporation, Ambion, Inc., and others.

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 and regulate such genes selectively through RNAi could provide a means to treat a wide range of human diseases. The discovery of RNAi has been heralded by many as a major breakthrough, and the journal Science named RNAi the top scientific achievement of 2002, as well as one of the top 10 scientific advances of 2003.

About Alnylam
Alnylam is a biopharmaceutical company seeking to develop and commercialize novel therapeutics based on RNA interference, or RNAi. Growing from its foundation as the world's first company focused on RNAi therapeutics, the company's leadership in the field of RNAi is supported by its preeminent founders and advisors and its strengths in fundamental patents, technology, and know-how that underlie the commercialization of RNAi therapeutics. Alnylam is developing a pipeline of RNAi products using Direct RNAi^™ to treat ocular, central nervous system, and respiratory diseases and Systemic RNAi^™ to treat a broad range of diseases, including oncology, metabolic, and autoimmune diseases. The company's global headquarters are in Cambridge, Massachusetts. For additional information, please visit www.alnylam.com.

Alnylam Forward Looking Statements
Various statements in this release concerning our future expectations, plans, prospects and future operating results 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: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales and distribution of our products; the successful development of products, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; obtaining, maintaining and protecting intellectual property utilized by our products; and our short operating history; as well as those risks more fully discussed in the "Certain Factors That May Affect Future Results" section of our most recent Form 10-Q filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.

SOURCE: Alnylam Pharmaceuticals, Inc.

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Alnylam Pharmaceuticals, Inc
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