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News Release - July 30, 2007
Alnylam and Medtronic Advance Collaboration on Drug-Device Combinations with RNAi Therapeutics for CNS DiseasesCollaboration Focuses on RNAi Therapeutic Program for Huntington's Disease
MINNEAPOLIS & CAMBRIDGE, Mass.--(HSMN NewsFeed)--Medtronic, Inc., (NYSE: MDT ) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY ), a leading RNAi therapeutics company, announced today that the companies are advancing their collaboration initiated in February, 2005, following positive pre-clinical data generated under the initial joint technology development phase of the program.
Under the terms of the agreement, Alnylam and Medtronic will focus on developing a drug-device combination for the treatment of Huntington's disease. The product is expected to consist of an RNAi therapeutic targeting the Huntington's disease gene that will be delivered by Medtronic's implantable infusion pump. In addition, the companies may jointly decide to collaborate on the development of similar drug-device combinations using Alnylam's RNAi therapeutics platform and Medtronic's implantable infusion pump for the treatment of other neurodegenerative diseases, such as Parkinson's disease.
The agreement has also been revised as a 50/50 relationship in the United States. Medtronic will commercialize the therapy consisting of the identified RNAi compound and advanced delivery devices. In the United States, Alnylam has the opportunity to invest in clinical development of this therapy through product launch. In Europe, Medtronic is solely responsible for development and commercialization.
"We have been very pleased with the progress made to date by the scientific teams at Alnylam and Medtronic. Pre-clinical data from our Huntington's disease program provide a strong rationale to advance an RNAi therapeutic program forward for this important disease where there are simply no effective therapies for patients today," said John Maraganore, President and Chief Executive Officer of Alnylam.
"We have proven expertise in delivering targeted therapies throughout the body, while Alnylam brings leadership in the evolving science of RNAi technology," said Stephen Oesterle, M.D., Medtronic senior vice president, medicine and technology. "Together, we are well positioned to explore drug-device combinations with a goal of discovering better ways to treat serious neurodegenerative diseases."
Alnylam has reported on data in its Huntington's disease program in a number of scientific meetings. Most recently, at the Keystone Symposium "RNAi for Target Validation and as a Therapeutic" in January, 2007, Alnylam collaborators presented in vivo data demonstrating that an siRNA targeting the huntingtin gene inhibited the progression of Huntington's disease in a mouse model. These results showed both a reduction of neuronal pathology and an improvement in abnormal behavior, where pathological protein aggregates were decreased by about 70 percent and two types of abnormal behavior - clasping and footslips - were ameliorated by approximately 50 percent and 70 percent, respectively. In addition, levels of the huntingtin protein that mediates Huntington's disease were reduced by about 70 percent.
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. It represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today and 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.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its website is www.medtronic.com.
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.
Medtronic Forward-Looking Statements
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
Alnylam Forward-Looking Statements
Various statements in this release concerning our future expectations, plans, and prospects, including without limitation statements with respect to development of a novel drug-device combination for the treatment of Huntington's disease and future payments to Alnylam under the collaboration with Medtronic, 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.
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