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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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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
06:08 EDTALNYAlnylam 4.737M share Secondary priced at $95.00
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