VANCOUVER, BC and CAMBRIDGE, MA, March 7 /PRNewswire-FirstCall/ - Inex Pharmaceuticals Corporation and Alnylam Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) has allowed claims in a patent application that covers nucleic acid-lipid compositions, including cationic liposomes, a family of specialized lipid molecules. Cationic liposomes enable the delivery of oligonucleotides, including small interfering RNAs (siRNAs), the molecules that mediate RNAi. The USPTO issued a “Notice of Allowance” for patent application 09/431,594, which is derived from the “Wheeler” patent series and includes a number of patents licensed exclusively to INEX through agreements with the University of British Columbia, and which Inex has exclusively licensed to Alnylam for RNAi therapeutics. Following a “Notice of Allowance,” the companies would expect final issuance of the patent within six months.
Cationic liposomes have been used as formulations to achieve systemic delivery of RNAi therapeutics in animal models including non-human primates (Zimmermann et al. (2006) Nature 441, 111-114). The newly allowed Wheeler patent covers cationic liposome compositions that contain oligonucleotides, including double-stranded RNAs such as siRNAs. In addition to the newly allowed patent, INEX and Alnylam have exclusive access to additional issued patents for delivery of oligonucleotides with cationic liposomes, including certain issued patents in the Wheeler patent series (U.S. Patent Nos. 5,976,567 and 6,815,432) and “Semple” patent series (U.S. Patent # 6,858,225).
“Our broad and significant collaboration with Alnylam formed just this past January unites INEX’s leadership in liposomal delivery technology with Alnylam’s leadership in RNAi therapeutics,” said Timothy M. Ruane, President and Chief Executive Officer of INEX. “The strength of INEX’s intellectual property was an important strategic component for this collaboration, and we’re gratified that the USPTO continues to recognize the Wheeler patent series for delivery of oligonucleotide therapeutics, including double-stranded RNAs such as siRNAs.”
“In a number of published reports from Alnylam and several other groups, systemic delivery of RNAi therapeutics has advanced significantly over the last few years with the use of liposome technology. Accordingly, we have focused on extending our leading intellectual property position in RNAi therapeutics by accessing needed patents covering certain delivery formulations,” said Robert Millman, Ph.D., Chief Intellectual Property Counsel for Alnylam. “Given both the newly allowed claims and previously issued patents, we believe that the Wheeler and Semple patent series represent the broadest intellectual property estate covering lipid-based delivery technologies for RNAi therapeutics.”
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 INEX
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.
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, 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 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.
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 strength of Alnylam’s intellectual property position, 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.
CONTACT: Cynthia Clayton (Investors), Alnylam Pharmaceuticals, Inc., (617) 551-8207; Ian Mortimer (Investors), Inex Pharmaceuticals Corporation, (604) 419-3200; Kathryn Morris (Media), KMorrisPR, (845) 635-9828; Karen Cook Boas (Media), James Hoggan and Associates, (604) 739-7500
Inex Pharmaceuticals Corporation
CONTACT: Cynthia Clayton (Investors), Alnylam Pharmaceuticals, Inc., (617)551-8207; Ian Mortimer (Investors), Inex Pharmaceuticals Corporation, (604)419-3200; Kathryn Morris (Media), KMorrisPR, (845) 635-9828; Karen CookBoas (Media), James Hoggan and Associates, (604) 739-7500
