Alnylam and Inex Form Strategic Technology Alliance to Discover and Develop RNAi Therapeutics with Lipid-Based Delivery Formulations.
"This new, exclusive license further enhances Alnylam's delivery capabilities and intellectual property estate, and continues to strengthen our leadership position in RNAi therapeutics," said Barry Greene, Chief Operating Officer of Alnylam. "We view Inex as having important intellectual property and capabilities in the area of lipid-based drug delivery systems, and believe that access to this technology is important as we advance systemic RNAi therapeutics and continue to build a leading biopharmaceutical company."
"We are pleased to be expanding and strengthening our overall relationship with Alnylam, which provides Inex the opportunity to develop RNAi therapeutics through our InterfeRx licenses," said Timothy M. Ruane, President and Chief Executive Officer of Inex. "We view Alnylam as the leading company in the development of RNAi therapeutics, and by working with Alnylam, Inex and its stakeholders will be best positioned to realize the value of lipid-based delivery technologies in the RNAi field."
Under the terms of the agreement, Inex will receive an upfront payment of $8.0 million in newly issued shares of Alnylam common stock and/or cash, at Alnylam's option. In addition, Inex will receive $4.0 million in R&D funding over the next two years to continue to identify and develop lipid-based delivery systems for Alnylam. Inex will provide contract manufacturing services on an exclusive basis for Alnylam proprietary products in the collaboration and Alnylam will make available a $5.0 million loan for capital equipment expenditures related to manufacturing capabilities. Inex is also eligible to receive $13.0 million in potential milestone payments for each product utilizing Inex technology, of which $9.5 million are due upon regulatory approval and successful commercialization with over $500 million in cumulative product sales, plus royalties on product sales. All figures quoted are in U.S. dollars.
As part of the collaboration, Alnylam has also granted Inex an option for three InterfeRx RNAi therapeutic target licenses, subject to Alnylam review and Alnylam third-party obligations. Finally, Alnylam has granted Inex an exclusive license to Alnylam technology and intellectual property for discovery, development, and commercialization of immune stimulatory oligonucleotides that do not function through an RNAi mechanism.
Liposomal and/or lipid nanoparticle formulations are important technologies for systemic delivery of RNAi therapeutics. Inex's intellectual property estate is comprised of certain key, issued patents, such as those derived from the Wheeler and Semple patent series (U.S. Patent Nos. 5,976,567, 6,815,432, and 6,858,225), that are considered important for the development and commercialization of liposomal and/or lipid nanoparticle formulations of oligonucleotide therapeutics, including small interfering RNAs (siRNAs), the molecules that mediate RNAi. Alnylam published groundbreaking results in March 2006 demonstrating, for the first time, therapeutic gene silencing in primates with systemically delivered RNAi therapeutics; these results were obtained using liposomal formulations. Alnylam intends to advance its RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia to an investigational new drug (IND) application in 2007. The systemically administered RNAi therapeutic is expected to employ a lipid nanoparticle formulation.
"The licensing of Inex's delivery technology is another example of Alnylam's strategy of consolidating intellectual property critical for the development and commercialization of RNAi therapeutics," said Robert Millman, Chief Intellectual Property Counsel of Alnylam. "Exclusive access to such intellectual property relating to delivery formulations complements our leading position in fundamental intellectual property related to RNAi."
About RNA Interference (RNAi)
RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. The discovery of RNAi has been widely acknowledged as a major breakthrough in biology, and the technology was recognized for its potential broad impact in medicine with the award of the 2006 Nobel Prize for Physiology or Medicine. 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 targeted gene silencing.
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, Novartis, and Biogen Idec. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts, and has an additional operating unit in Kulmbach, Germany. For more information, visit www.alnylam.com.
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about Inex and this news release can be found at www.inexpharm.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam's future expectations, plans, and prospects, including with respect to the development and systemic delivery of RNAi therapeutics, the importance of liposomal and/or lipid nanoparticle formulations for systemic delivery and the timing for filing and IND for, and the development of, an RNAi therapeutic targeting PCKS9 for the treatment of hypercholesterolemia, 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: Alnylam's approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; Alnylam's ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by Alnylam's products; Alnylam's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Alnylam's ability to obtain additional funding to support its business activities; Alnylam's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of Alnylam's product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to Alnylam's and others developing products for similar uses; Alnylam's dependence on collaborators; and its short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Alnylam's most recent report on Form 10-Q on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.
INEX Forward-Looking Statements
There are forward-looking statements by INEX contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, INEX's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market INEX's products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. INEX disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
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|Date:||Jan 9, 2007|
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