Today's NEWS!!..
Inex provides liposomal licence to Alnylam
2007-01-09 08:39 ET - News Release
Mr. Timothy Ruane reports
ALNYLAM AND INEX FORM STRATEGIC TECHNOLOGY ALLIANCE TO DISCOVER AND DEVELOP RNAI THERAPEUTICS WITH LIPID-BASED DELIVERY FORMULATIONS
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, has taken a worldwide exclusive licence to Inex Pharmaceuticals Corp.'s liposomal delivery formulation technology for the discovery, development and commercialization of RNAi therapeutics, and the companies have expanded their technology research and manufacturing alliance on lipid-based delivery technology. In addition, Inex will receive three InterfeRx licence options, subject to Alnylam review and third party obligations, to develop its own RNAi therapeutic products. Inex will also receive exclusive access to Alnylam's intellectual property to develop oligonucleotide drugs that act through an immune stimulation mechanism, outside the RNAi pathway.
"This new, exclusive licence 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 licences," 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 research and development financing 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 using Inex technology, of which $9.5-million is 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 licences, subject to Alnylam review and Alnylam third party obligations. Finally, Alnylam has granted Inex an exclusive licence 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 consists 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.
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 United States. 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, Mass., and has an additional operating unit in Kulmbach, Germany. For more information, visit the company website.
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