Developing RNAi Therapeutics For Pandemic Flu - Novartis And Alnylam Announce New Collaboration

Main Category: Bird Flu / Avian Flu
Also Included In: Pharma Industry / Biotech Industry
Article Date: 21 Feb 2006 - 16:00 PDT

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Novartis and Alnylam Pharmaceuticals, Inc announced that they have formed a new collaboration to develop RNAi therapeutics for pandemic flu. This collaboration is in addition to the collaboration formed by the two companies in September 2005, and significantly reinforces the development program for pandemic flu announced by Alnylam in December 2005. In the newly formed collaboration, Alnylam and Novartis will advance RNAi therapeutics for pandemic flu to initial clinical testing and, if successful, regulatory approval. This new alliance leverages Alnylam's expertise in RNAi and Novartis' capabilities and experience in bringing innovative therapeutics to patients. Financial terms were not disclosed.

"We are delighted to work with our colleagues at Alnylam to devise new therapies for influenza. The influenza virus, through rapid mutation and potential inter-species transfer, represents an epidemic threat to the citizens of all countries. Multiple therapies are likely to be required both to prevent and to treat influenza," said Mark Fishman, M.D., President of the Novartis Institutes for BioMedical Research. "An RNAi therapeutic could be an innovative modality, crippling the virus through incapacitating several genes. In addition, such drugs might be adapted to new strains as they emerge. Of course, the technology is young and is just now being tested in early clinical trials, but our hope is that it will open new therapeutic frontiers."

In December 2005 Alnylam announced that it had selected its pandemic flu program as a development program. The company also announced that it had received initial government funding for the program from the Department of Defense's 'Defense Advanced Research Projects Agency' (DARPA). The focus of the program is the development of an RNAi therapeutic targeting sequences both specific for particular strains and conserved across all flu strains, including those of avian origin. This RNAi therapeutic would be expected to have anti-viral activity against any newly emerging strain of influenza capable of causing human disease and leading to a pandemic, including any variant of the H5N1 strain.

"Having experienced the benefits of collaborating with Novartis over the last several months, we are delighted to partner with them in tackling what may be the biggest public health threat facing the world today," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals. "Working together with Novartis and government agencies, we are confident in our ability to harness the power of RNAi to help prepare for the possibility of a global influenza pandemic. This new collaboration significantly enhances the efforts we announced in December 2005 to advance our RNAi therapeutic program in pandemic flu toward the clinic."

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, has spread to parts of Europe and Africa, and has caused 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 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 http://www.alnylam.com.

Alnylam Forward-Looking Statements

Various statements in this release concerning our future expectations, plans, and prospects, including our plans with respect to the discovery and development of an RNAi therapeutic for pandemic influenza and our views with respect to the potential for RNAi therapeutics, including an RNAi therapeutic for pandemic influenza, 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.

Alnylam

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