Dec 14, 2005 Press Release for Alnylam

Alnylam Announces Pandemic Flu as Next Development Program; Obtains Initial Federal Funding to Develop RNAi Therapeutics for Pandemic Influenza and Identifies Dowpharma(SM) as Potential Source for Domestic Manufacturing

Dec 14, 2005

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 14, 2005--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today its decision to advance its pandemic flu project as a development program, adding to the company's growing pipeline of RNAi therapeutics. Alnylam also announced that it has received initial government funding for the program from the Department of Defense's 'Defense Advanced Research Projects Agency' (DARPA). Alnylam expects to submit an investigational new drug (IND) application for an RNAi therapeutic for pandemic flu as early as the end of 2006.

In addition, Alnylam also announced today that Dowpharma(SM) contract manufacturing services, a business unit of The Dow Chemical Company (Midland, Michigan), has signed a letter of support indicating its desire and intent to cooperate with Alnylam relating to the manufacture of an RNAi therapeutic for pandemic flu, creating the opportunity for domestic production.

Alnylam will continue its ongoing research collaborations relating to influenza with the University of Georgia and researchers at St. Jude Children's Research Hospital.

"We believe that RNAi therapeutics can play an important role in effective preparedness for a global influenza pandemic, providing a new option for the treatment and prevention of highly virulent strains of flu," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals. "Our recent success in initiating clinical studies for ALN-RSV01, an RNAi therapeutic for respiratory syncytial virus infection, lays the groundwork for rapidly developing a therapeutic for flu. Moreover, with initial federal funding, the support of Dowpharma, and our relationships with world-leading academic centers, we are building a strong collaborative network in both the private and public sectors to address a potentially major global health issue."

The Alnylam pandemic flu program is focused on the development of an RNAi therapeutic targeting sequences that are highly conserved across all flu genomes, including those of avian origin such as the H5N1 strain. This RNAi therapeutic would be expected to have anti-viral activity against any newly emerging strain of influenza that could cause human disease. The company believes that such an RNAi therapeutic could be stockpiled in advance of a flu pandemic as a complement to vaccines and other anti-virals.

Alnylam will be presenting updates on its research and development programs, including its pandemic flu program, at its R&D Day to be held this morning at 9:00 a.m. ET at Le Parker Meridien in New York City. The event will be webcast live on the "Investors" section of the company's website at www.alnylam.com. A replay of the presentation will be posted on the Alnylam website approximately three hours after the event, and will be archived for 30 days.

About Pandemic Influenza
An influenza pandemic is a global outbreak of disease that occurs when a new flu virus appears in the human population, causes serious illness, and spreads easily from person to person. Experts believe that current vaccines and existing anti-viral agents may not be sufficient to protect against newly emerging strains of influenza virus. Over the last several years, a highly virulent new strain of avian flu (H5N1) has become endemic in the poultry population in Southeast Asia and causes significant mortality in humans that have been infected. The World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) have expressed major concern about the potential for this virus to mutate into a form that could cause a global pandemic of human disease.

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 a breakthrough in biology known as RNA interference, or RNAi. The company, founded in 2002 by scientific pioneers in the field of RNAi, maintains a leadership position in fundamental patents, technology, and know-how relating to RNAi. Alnylam is applying its expertise in RNAi to address multiple therapeutic opportunities that cannot effectively be addressed with small molecules or antibodies, the two current major classes of drugs. The company's expertise in designing and optimizing RNAi therapeutics has enabled Alnylam to form major alliances with leading companies including Merck, Medtronic, and Novartis. The company's global headquarters are in Cambridge, Massachusetts, with an additional operating unit in Kulmbach, Germany. For more information, please visit www.alnylam.com.

Alnylam Forward-Looking Statements
Various statements in this release concerning our future expectations, plans, and prospects, including without limitation our plans with respect to the discovery and development of, and the submission of an IND application for, an RNAi therapeutic for pandemic influenza and our views with respect to the potential for RNAi therapeutics, including without limitation, an RNAi therapeutic for pandemic influenza, the activity of such a therapeutic and the ability to stockpile such a therapeutic, 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. Finally, information in this press release related to funding from DARPA does not necessarily reflect the position or the policy of the U.S. government and no official endorsement should be inferred.

SOURCE: Alnylam Pharmaceuticals, Inc.

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Alnylam Pharmaceuticals, Inc., or
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