Alnylam Awarded $38.6 Million U.S. Government Contract to Develop RNAi Therapeutics for Biological Threats
Thursday August 9, 8:00 am ET
- Funding to Support Alnylam Biodefense(TM) and RNAi Technology Development Efforts -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, announced today that it has been awarded a $38.6 million contract over 33 months from the United States Defense Threat Reduction Agency (DTRA) to develop a broad spectrum RNAi anti-viral therapeutic for the treatment of viral hemorrhagic fever. Viral hemorrhagic fevers are considered by federal agencies to be high priority agents that pose a risk to national security because they can be easily disseminated from person to person, result in high mortality rates, and require special action for public health preparedness.
The Alnylam Biodefense initiative has the potential to create near-term value from the company's RNAi therapeutic platform, such as obtaining FDA approval for products in an accelerated timeframe and revenues from government stockpiling. In addition, funding from this initiative allows Alnylam to further extend its capabilities in a manner that can be leveraged across its entire proprietary and partnered pipeline.
"This funding represents continued federal government support of RNAi as a potential therapeutic platform for biodefense and biopreparedness, while allowing us to continue to develop our technology as we advance our pipeline programs," said Barry Greene, Chief Operating Officer of Alnylam. "Combined with our Ebola contract from the National Institutes of Health for $23 million awarded in September 2006 and other sources of federal funding, we have now been granted more than $63 million in federal contracts for Alnylam Biodefense."
The goal of this research program is to develop an RNAi therapeutic for the treatment of hemorrhagic fever virus infection. Alnylam's program will investigate the silencing of endogenous host targets believed to be involved in viral pathogenesis and disease progression. This new contract fully supports all activities from program initiation through Phase I trials. With this program, as with its Ebola program, Alnylam is working with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), an organization uniquely experienced in the handling, safety, and security requirements of specialized biological agents. Alnylam will be producing drug candidates which will be sent to USAMRIID for in vitro and in vivo testing against viral hemorrhagic fevers.
This new federal contract (No. HDTRA1-07-C-0082) is with the DTRA 2007 Medical Science and Technology Chemical and Biological Defense Transformational Medical Technologies Initiative (TMTI), whose mission is to protect the warfighter from conventional or genetically engineered biological threats, known or emergent, by accelerating the seamless discovery and development of broad spectrum medical countermeasures through the use of novel technology platforms and innovative management approaches.
About Alnylam Biodefense(TM)
Alnylam Biodefense was established to build a robust platform for developing RNAi therapeutics targeting threats of bioterrorism. Funding for the company's Ebola virus, pandemic flu, and viral hemorrhagic fever programs represents an example of broad public health and federal interest in the potential of RNAi technology to treat and prevent disease from these, and other serious and life-threatening viruses. Government funding extends Alnylam's anti-viral pipeline, which includes programs for treatment of: respiratory syncytial virus (RSV) infection with ALN-RSV01, which is in Phase II human clinical trials; pandemic influenza with ALN-FLU01 in a partnership with Novartis; and JC virus in a partnership with Biogen Idec.
About RNA Interference (RNAi)
RNAi 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 USAMRIID
The United States Army Medical Research Institute (USAMRIID), located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.
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 influenza, hypercholesterolemia, and liver cancers, amongst other diseases. 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, Novartis, Biogen Idec, and Roche. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts. For more information, visit www.alnylam.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; our ability to fund and the results of further pre-clinical and clinical trials; 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 obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, 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 "Risk Factors" 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.
Contact:
Alnylam Pharmaceuticals, Inc.
Investors:
Cynthia Clayton, 617-551-8207
or
Media:
KMorrisPR
Kathryn Morris, 845-635-9828
--------------------------------------------------------------------------------
Source: Alnylam Pharmaceuticals, Inc.
|
