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January 13, 2014
05:21 EDTALNY, SNYAlnylam, Genzyme form transformational alliance for RNAi therapeutics
Alnylam Pharmaceuticals (ALNY) and Genzyme, a Sanofi company (SNY), announced that they have formed a transformational alliance for the development and commercialization of RNAi therapeutics as genetic medicines. Alnylam will retain product rights in North America and Western Europe, while Genzyme will obtain the right to access Alnylam’s current “5x15”1 and future genetic medicines pipeline in the rest of the world, or ROW, including global product rights for certain programs. In addition, Genzyme becomes a major Alnylam shareholder through an upfront purchase of $700M of newly issued stock at approximately $80/share, representing an approximately 12% ownership position. This alliance significantly bolsters Alnylam’s balance sheet to over $1B in cash, enabling an increased investment in the company’s RNAi therapeutics pipeline and is expected to secure Alnylam’s financial independence through to multiple product launches. Upon the closing of the transaction, Genzyme will opt-in to patisiran, or ALN-TTR02, – an RNAi therapeutic currently in a Phase 3 trial for the treatment of transthyretin, or TTR-mediated amyloidosis, or ATTR patients with Familial Amyloidotic Polyneuropathy – for its ROW territories, while Alnylam retains full product rights in North America and Western Europe. Alnylam and Genzyme have also agreed to expand their current collaboration on ALN-TTRsc – an RNAi therapeutic currently in a Phase 2 trial for the treatment of ATTR patients with TTR amyloid cardiomyopathy – where the parties will co-develop and co-promote ALN-TTRsc in North America and Western Europe; Alnylam will maintain development and commercialization control with ALN-TTRsc and Genzyme will develop and commercialize the product in its ROW territories. The companies believe that this broadened collaboration on ALN-TTRsc will increase the product’s overall value, as significant market development and commercial operational scale is warranted to maximize the opportunity for both familial cardiac amyloidosis senile systemic amyloidosis manifestations of TTR cardiac amyloidosis.
News For ALNY;SNY From The Last 14 Days
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July 31, 2014
19:08 EDTSNYSanofi raises stake in Regeneron to 22.5% from 21.6%
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05:56 EDTSNYSanofi reports Q2 business net income up 13% to EUR 1.54B
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July 30, 2014
16:31 EDTSNYRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
12:33 EDTSNYRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
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08:08 EDTSNYSanofi and Regeneron report positive Phase 2 results of alirocumab
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July 29, 2014
07:20 EDTALNYAlnylam to hold a roundtable
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July 28, 2014
09:02 EDTSNYSanofi, InnerWorkings sign global marketing partnership
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July 22, 2014
08:03 EDTALNYAlnylam receives USPTO Notice of Allowance for Manoharan ’478 patent
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07:22 EDTALNYAlnylam to hold a webinar
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July 21, 2014
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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