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Jan 13, 2014

Alnylam Strengthens RNAi Position

  • Alnylam inked two RNAi-related deals in the last 12 hours that solidify its leading RNAi therapeutic development position.

    On Sunday night, Alnyam Pharmaceuticals reported the acquisition of Merck’s subsidiary Sirna Therapeutics and its intellectual property and RNAi assets including preclinical therapeutic candidates, chemistry, siRNA-conjugate and other delivery technologies. Alnylam will give Merck $175 million in cash and equity up front. In addition, Merck is eligible to receive up to $105 million in developmental and sales milestone payments per product, as well as single-digit royalties, associated with the progress of certain preclinical candidates discovered by Merck. Merck is also eligible to receive up to $10 million in milestone payments and single-digit royalties on Alnylam products covered by Sirna Therapeutics’ patent estate.

    Not 12 hours later, on Monday morning, just in time for the opening of the JP Morgan annual meeting, Alnylam reported a major investment from Sanofi and an expanded commitment to rare disease research with Genzyme, a Sanofi company. Most significant is Genzyme’s purchase of $700 million of Alnylam stock (8.8 million shares at $80/share). Through this transaction Genzyme becomes an approximately 12% owner of Alynlam. According to the companies, the new Alnylam-Genzyme alliance is valued at well over $1 billion, including equity, R&D funding, and potential milestone payments.

    "In this new alliance, Alnylam benefits enormously from Genzyme's proven global capabilities, enabling us to accelerate and expand market access for our ‘Alnylam 5x15' products. At the same time, we retain our product rights in North America and Western Europe, where we remain committed to develop and commercialize our RNAi therapeutics pipeline. We also retain full global product rights for all RNAi therapeutic products outside the genetic medicine field. In addition, this new collaboration significantly expands our balance sheet to over $1 billion in cash to increase our investment in new RNAi therapeutic programs, while securing a cash runway that we believe will allow us to develop and launch multiple products," said John Maraganore, Ph.D., CEO of Alnylam, in a statement.

    Alnylam and Genzyme began collaborating in 2012 when they formed a partnership to develop and commercialize Alnylam's lead product, patisiran, which is in Phase III development for the treatment of transthyretin (TTR)-familial amyloid polyneuropathy.

    The expanded relationship between Genzyme and Alnylam includes the following components: First, Genzyme will obtain expanded rights to patisiran. Under the original agreement, Genzyme had rights to commercialize patisiran in Japan and the broader Asia-Pacific region. Under the expanded agreement, Genzyme will now commercialize patisiran in all territories outside of North America and Western Europe, which are retained by Alnylam for their commercialization.

    Second, Genzyme will obtain rights to commercialize worldwide three products in Alnylam's pipeline. Specifically, (1) Genzyme and Alnylam will co-develop and co-commercialize ALN-TTRsc, a product currently in Phase II development for the treatment of familial amyloid cardiomyopathy, in North America and Western Europe, while Genzyme commercializes the product in the rest of world; (2) Genzyme will have the rights to two additional products after the completion of early clinical trials and will be able to choose between full global rights or co-commercialization rights, depending on the product.

    Third, Genzyme will have the option up until 2020, with the possibility of extension through the end of 2021,to develop and commercialize outside of North America and Western Europe all products being developed to treat rare genetic diseases from Alnylam's pipeline. Alnylam retains its rights to co-develop and co-commercialize its genetic medicine pipeline in North America and Western Europe.

    In addition, Alnylam will receive R&D funding, starting on January 1, 2015, for programs where Genzyme has elected to opt-in for development and commercialization. Further, Alnylam is eligible to receive milestones and royalties.

    As part of its “Alnylam 5x15” strategy, as updated in early 2014, the company expects to have six to seven genetic medicine product candidates in clinical development - including at least two programs in Phase III and five to six programs with human proof of concept - by the end of 2015.



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