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Our unparalleled intellectual property (IP) position, success in creating a robust product platform, and advances in delivery are widely recognized by leading, innovative pharmaceutical and biotechnology companies. This recognition is reflected by the major strategic alliances that we have formed. These innovative alliances are true win-win partnerships that drive our business forward while enabling our partners to develop and commercialize RNAi therapeutics worldwide. They are a keystone element of our strategy to build a leading biopharmaceutical company that creates important therapeutics and , in turn, value for our stockholders.
- Arrowhead Research Corporation
In January 2012, Alnylam granted Arrowhead a license under its intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus (HBV). Alnylam is eligible to receive from Arrowhead milestone payments and royalties on sales of product resulting from the license. In addition, Alnylam has received a license from Arrowhead to utilize their Dynamic Polyconjugate (DPC) delivery technology for an RNAi therapeutic product. Alnylam expects to deploy this technology for an undisclosed target in its Alnylam 5x15 pipeline which is focused on genetically defined targets and diseases. Arrowhead is eligible to receive from Alnylam milestone payments and royalties on sales of product resulting from the license.
- Ascletis Pharmaceuticals
In July 2012, Ascletis received an exclusive license from Alnylam to develop and commercialize ALN-VSP in China including Hong Kong, Macau, and Taiwan. The focus will be on advancing ALN-VSP into a Phase II study for the treatment of HCC. Alnylam will retain all rights in the rest of the world, and is eligible to receive milestones and royalties based on product sales. In addition, Alnylam may use the data generated in China by Ascletis under this strategic collaboration for development of ALN-VSP in the rest of the world.
In August 2012, Regulus entered into a strategic alliance with AstraZeneca to discover, develop, and commercialize microRNA therapeutics for three exclusive targets which are currently in pre-clinical development. These targets are focused on cardiovascular and metabolic diseases and oncology.
- Biogen Idec
In September 2006, Alnylam and Biogen Idec, Inc. formed a collaboration to develop RNAi therapeutics for the treatment of progressive multifocal leukoencephalopathy (PML). PML is caused by infection of the central nervous system with a virus called "JC virus" and can occur in certain immune-suppressed patients, including those receiving immunomodulatory therapies. Alnylam and Biogen Idec will initially conduct investigative research into the potential of using RNAi technology to develop therapeutics to treat PML. Under terms of the collaboration, Biogen Idec, Inc. funds all research and development activities.
In August 2012, Regulus entered into a collaboration with Biogen Idec to identify microRNAs as biomarkers for multiple sclerosis (MS). Under the terms of the agreement, Biogen Idec will make an investment in Regulus in addition to upfront and milestone payments. The key objective of the collaboration is to identify microRNA biomarkers in the blood of patients with MS.
- Genzyme, a Sanofi company
In October 2012, Alnylam and Genzyme, a Sanofi company, formed an exclusive alliance to develop and commercialize RNAi therapeutics targeting transthyretin (TTR) for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries. Genzyme will advance our ALN-TTR program with their proven capabilities in the Japanese and broader Asian market, while we maintain responsibility to develop and commercialize ALN-TTR in the U.S., Europe, and rest of world. The agreement also includes development milestone payments and tiered royalties expected to yield an effective rate in the mid-teens to mid-twenties on Genzyme's sales of ALN-TTR products in their territory.
- GlaxoSmithKline plc
In November 2011, we announced a collaboration with GlaxoSmithKline focused on our VaxiRNA™ technology for certain GSK vaccine products. The GSK collaboration is initially focused on influenza vaccine production in cell culture systems, for which GSK will provide funding and certain milestone payments to Alnylam. If successfully applied in the manufacture of commercial product, Alnylam will receive payments on unit product sales. In addition, GSK has obtained an option for VaxiRNA applications toward two additional vaccine products
In April 2008, GSK and Regulus Therapeutics formed the first ever microRNA-focused strategic alliance to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. The alliance provides GSK with options for exclusive worldwide licenses to develop and commercializes candidates directed at four different microRNA targets. Regulus is responsible for the discovery and development of these microRNA antagonists through completion of clinical proof of concept.
- Isis Pharmaceuticals, Inc.
In March 2004, Alnylam entered into a broad, strategic collaboration and license agreement with Isis, a leading developer of single-stranded antisense oligonucleotide drugs. The agreement enhances Alnylam's intellectual property position with respect to RNAi-based therapeutics and its ability to develop and commercialize 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.
- Kyowa Hakko Kiran Co., Ltd.
In June 2008, Alnylam and Kyowa Hakko formed an exclusive alliance to develop and commercialize ALN-RSV01, a RNAi therapeutic in clinical development for the treatment of respiratory syncytial virus (RSV) infection, in Japan and other major markets in Asia. The partnership also includes additional RSV-specific RNAi therapeutic compounds that comprise the ALN-RSV program. In the rest of the world outside of Asia, ALN-RSV is partnered with Cubist Pharmaceuticals as a milestone- and royalty-bearing license arrangement, and a 50-50 co-development and profit share arrangement in North America.
- The Medicines Company
AIn February 2013, The Medicines Company and Alnylam announced an exclusive global alliance to advance the ALN-PCS program. The collaboration includes program includes ALN-PCS02 an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program while funded by The Medicines Company for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. The Medicines Company will then lead and fund development from Phase II forward and commercialize the ALN-PCS program if successful.
- Medtronic, Inc.
ALN-HTT is the drug under development as part of a drug-device combination therapy for the treatment of Huntington's disease being advanced in collaboration with Medtronic, Inc. and CHDI Foundation, Inc. As part of its alignment of resources on its ATTR and hemophilia programs, Alnylam has elected to exercise its option under its agreement with Medtronic to opt-out of the 50-50 expense/profit share arrangement of the ALN-HTT program. If Medtronic decides to continue the ALN-HTT program, Alnylam would continue to supply ALN-HTT drug product for the program and would be entitled to receive milestones and royalty payments on future annual net sales.
In August 2012, Alnylam and Monsanto formed a strategic alliance to advance biological technologies in the field of agriculture. The new alliance brings Alnylam's broad RNAi-based intellectual property (IP) and proprietary technologies to Monsanto's new BioDirect™ technology, which aims to deliver innovative biological solutions for farmers. Under the terms of the agreement, Monsanto receives worldwide, exclusive rights to use Alnylam's platform technology and IP in the field of agriculture, including the ability to grant sublicenses. The agreement also includes the transfer of technology from Alnylam to Monsanto and a collaborative research project. Moreover, Monsanto becomes Alnylam's strategic partner in agriculture for a 10-year period.
- Novartis AG
In September 2005, Alnylam and Novartis Institute for BioMedical Research (NIBR), the research institute of Novartis AG, formed a landmark RNAi therapeutics alliance. The 5 year collaboration, completed in 2010, was created discover, develop, and commercialize RNAi therapeutics for 31 gene targets exclusively selected by Novartis. In return, for any RNAi therapeutic products Novartis develops against these targets, Alnylam is entitled to receive significant milestone payments upon achievement of certain specified development and annual net sales events.
In June 2010, Regulus entered into a global, strategic alliance with sanofi–aventis to discover, develop, and commercialize microRNA therapeutics. The alliance will initially focus on the therapeutic area of fibrosis. Regulus a nd sanofi–aventis will collaborate on up to four microRNA targets, including Regulus' lead fibrosis program targeting microRNA-21. Sanofi–aventis will provide annual research support for three years with the option to extend two additional years. Regulus is eligible to receive royalties on microRNA therapeutic products commercialized by sanofi aventis. Sanofi-aventis will support 100 percent of the costs of clinical development and commercialization of each program. In addition, sanofi–aventis also receives an option for a broader technology alliance that provides Regulus certain rights to participate in development and commercialization of resulting products. Alnylam and Isis are each eligible to receive 7.5 percent of all potential milestone payments, in addition to royalties on product sales.
- Takeda Pharmaceutical Company Limited
In May 2008, Alnylam and Takeda formed a strategic platform alliance that provides Takeda with broad, worldwide, non-exclusive access to and enablement with Alnylam's RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets. In addition, Alnylam retains the right to opt-in as late as the beginning of Phase III to co-develop and co-commercialize four Takeda RNAi therapeutic programs in the U.S. market on a 50-50 basis. This landmark alliance is the first major RNAi therapeutics partnership between a Japanese pharmaceutical company and a U.S. biotechnology company and represents a new frontier in the advancement of RNAi therapeutics to patients on a global basis.