Healthcare Industry News:  RNAi therapeutic 

Biopharmaceuticals Licensing

 News Release - May 24, 2006

Alnylam Grants Bioneer License to Kreutzer-Limmer Patents for the RNA Interference (RNAi) Research Products Market

CAMBRIDGE, Mass. & DAEJEON, South Korea--(HSMN NewsFeed)--May 24, 2006--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY ), a leading RNAi therapeutics company, and Bioneer, Inc., a leading synthetic oligonucleotide manufacturer, announced today that Alnylam has granted Bioneer a non-exclusive license to provide RNAi research products under the Kreutzer-Limmer patent family. This patent family, owned exclusively by Alnylam, covers small interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells.

"Granting rights to the Kreutzer-Limmer patent family represents one important component of Alnylam's strategy to build value now and in the future through its intellectual property estate," said Roland Kreutzer, Ph.D., Managing Director of Alnylam Europe AG. "Execution of this license agreement with Bioneer, one of the largest oligonucleotide manufacturers in the world, continues to underscore the value of the Alnylam-owned Kreutzer-Limmer patent family as a critical component of fundamental intellectual property in the field of RNAi. This agreement brings the number of licenses Alnylam has executed granting rights to its intellectual property estate to more than 20, including 12 with research product suppliers. In addition, we believe that a significant portion of sales of siRNAs for research purposes are currently being made under access to Alnylam's intellectual property."

"Taking a license to the Kreutzer-Limmer patent family strengthens our ability to provide synthetic oligonucleotides to our customers," said Nisha Sahay, Ph.D., Director of Marketing of Bioneer, Inc. "This license enables Bioneer to execute on our mission of bringing state-of-the art research tools to the biotech industry worldwide in this exciting post-genomic era."

Alnylam's IP estate includes certain "fundamental" patents and patent applications that claim the broad structural and functional properties of synthetic RNAi products. These include the Kreutzer-Limmer I and II patents, acquired through the Ribopharma merger: EP Patent No. 1144623, covering methods, medicaments and uses of siRNAs with up to 25 nucleotides complementary to a target gene; EP Patent No. 1214945, covering compositions, methods, and uses of siRNAs with a length between 15 and 49 nucleotides; and EP Patent No. 1352061, covering therapeutic compositions, methods, and uses of siRNA and derivatives directed toward over 125 disease targets. Additional fundamental patents licensed to Alnylam on an exclusive or non-exclusive basis include those of Crooke (U.S. Patent Nos. 5,898,031 and 6,107,094), Fire and Mello (U.S. Patent No. 6,506,559), Glover et al. (EP Patent No. 1230375), and the Tuschl II series (derived from WO 02/044321 and including recently allowed applications US 10/832,248 and US 10/832,432, with further patent applications pending). In addition, Alnylam has licenses to other fundamental patents pending, including Tuschl I (derived from WO 01/075164).

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 genes selectively through RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause highly targeted gene silencing.

About Alnylam

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 building a pipeline of RNAi therapeutics; its lead program is in Phase I human clinical trials for the treatment of respiratory syncytial virus (RSV) infection, which is the leading cause of hospitalization in infants in the U.S. 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 Merck, Medtronic, and Novartis. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts, and has an additional operating unit in Kulmbach, Germany. Alnylam is honored to be the "emerging/mid-cap" company recipient of the 2006 James D. Watson Helix Award, the biotechnology industry's award for outstanding achievement. For more information, please visit www.alnylam.com.

About Bioneer

Bioneer is a leading supplier of synthetic oligonucleotides, providing high-quality custom DNA oligos as well as GMP quality siRNA. The company has developed a proprietary super oligo synthesizer capable of producing 384 oligonucleotides in a single cycle, in parallel, by a patented multi matrix valve system. This unique system enables complete automation from order entry, order processing to shipment. Bioneer, Inc., the US/European division of the parent company is in the process of launching an oligonucleotide manufacturing facility in Alameda, California. In addition to serving the oligo market, the company is also actively involved in using its core competencies for the development of new siRNA drugs. Bioneer, established in 1992, is headquartered in South Korea with regional offices in the US and Europe and is supported by a global network of distributors throughout the world. For more information, please visit www.bioneer.com.

Alnylam Forward-Looking Statements

Various statements in this release concerning our 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 risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to enter into additional license agreements; 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; our dependence on collaborators; 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 report on Form 10-Q on file 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

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