Alnylam is capitalizing on the strength of its intellectual property (IP) estate by offering target-specific therapeutic licenses in areas outside Alnylam's strategic focus through its InterfeRx™ program. In addition, Alnylam is using its IP position to consolidate additional IP in the RNAi field.
In March 2004, Alnylam entered into a collaboration and license agreement with Isis, a leading developer of single-stranded antisense oligonucleotide drugs. The agreement further enhances Alnylam's intellectual property position with respect to RNAi-based therapeutics and its ability to develop and commericalize RNAi therapeutics. Isis granted Alnylam licenses to its current and future patents and patent applications relating to oligonucleotide chemistry and to RNA-targeting mechanisms for the research, development and commercialization of RNAi therapeutics.
In August 2004, Alnylam and Idera (formerly Hybridon) entered into an agreement providing Alnylam with an exclusive license to Idera's rights to target Vascular Endothelial Groth Factor (VEGF) for ocular indications with RNA interference molecules (RNAi). Idera has a series of patents and patent applications relating to the therapeutic use of oligonucleotides, including antisense and RNA interference compounds, which inhibit the production of the protein VEGF.
In January 2005, Alnylam granted GeneCare Research Institute Co., Ltd., a Japanese biotechnology firm, an exclusive license through the InterfeRxTM licensing program to discover, develop, and commercialize RNAi therapeutics directed against two DNA helicase genes associated with cancer. In addition, Alnylam retains the right to negotiate co-development and co-promotion arrangements for such products in the United States.
In April 2005, Alnylam and Benitec, a leading developer of DNA-directed RNA interference therapeutics, announced a licensing agreement covering fundamental IP in the field of RNAi. Under the agreement, Alnylam will provide Benitec and its licensees an option to non-exclusively license Alnylam-controlled IP in the field of expressed RNAi: targeted gene silencing mediated by short interfering RNAs (siRNAs) generated from DNA constructs introduced into cells. Benitec also provides Alnylam to non-exclusively license Benitec IP for expressed RNAi and synthetic siRNAs.
In August 2005, Alnylam granted Nastech Pharmaceutical Company an exclusive InterfeRxTM license to discover, develop and commercialize RNAi therapeutics directed against TNF-alpha, a protein associated with inflammatory diseases including rheumatoid arthritis.
In March 2006, Alnylam and Tekmira have entered into a research collaboration under which the two companies will explore the potential of various liposomal formulations for delivery of RNAi therapeutics.
In January 2007, Alnylam took a worldwide exclusive license to Tekmira's liposomal delivery formulation technology for the discovery, development, and commercialization of RNAi therapeutics, and the companies expanded their technology research and manufacturing alliance on lipid-based delivery technology. In addition, Tekmira will receive three InterfeRx™ license options, subject to Alnylam review and third-party obligations, to develop its own RNAi therapeutic products.
In May 2006, Alnylam obtained rights to RNAi delivery technology developed in the laboratory of Professor Judy Lieberman from the CBR Institute for Biomedical Research, a Harvard Medical School Affiliate. The in-licensed technology may enable small interfering RNAs – or siRNAs, the molecules that mediate RNAi – to be targeted with an engineered monoclonal antibody to tumors and other cell types, thereby broadening the scope of Alnylam's delivery technologies for RNAi therapeutics. The in-licensed technology, which was highlighted in an article published in the journal Nature Biotechnology in 2005, represents another potential approach for delivery of RNAi therapeutics with systemic administration
In August 2006, Alnylam granted Calando Pharmaceuticals (a majority-owned subsidiary of Arrowhead Research Corporation) an InterfeRx license to discover, develop, and commercialize an RNAi therapeutic utilizing a synthetic siRNA, together exclusively with Calando's proprietary delivery technology, that is directed towards a cancer target. As part of the agreement, Calando also has an option to acquire an InterfeRx license for a second target gene.
In September 2006, Alnylam granted granted Quark Biotech, Inc. InterfeRx licenses to discover, develop, and commercialize RNAi therapeutics targeting the p53 and RTP801 genes for certain diseases. Quark has filed investigational new drug (IND) applications for RNAi therapeutics for both targets, in the case of p53 for the treatment of renal failure, and in the case of RTP801 for the treatment of ocular diseases, specifically macular degeneration.