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News Breaks
January 13, 2014
05:39 EDTSNY, REGNRegeneron announces amendment to investor agreement with Sanofi
Regeneron Pharmaceuticals (REGN) announced that it has amended and restated its investor agreement with Sanofi (SNY), which was originally entered into in December 2007. Under the terms of the amended and restated agreement, Sanofi retains its right to acquire up to 30% of Regeneron's outstanding common stock and Class A stock and gains the right to nominate a single independent director to the Regeneron Board of Directors upon reaching 20% ownership of Regeneron's outstanding common stock and Class A stock. The new independent director must be approved by Regeneron's board based on Sanofi's proposals and not have any current or previous relationship with Sanofi. All shares of Regeneron's common stock owned by Sanofi now or in the future are subject to an amended "Lock-Up" provision that prohibits any sales through at least December 20, 2020 and imposes certain restrictions on the manner of sales thereafter. In addition, Sanofi has agreed to be bound by an amended voting agreement which specifies that Sanofi must vote its shares as recommended by Regeneron's board except in certain defined circumstances, and revised "standstill" provisions that continue to prohibit Sanofi from seeking to directly or indirectly exert control over Regeneron or acquiring more than 30% of Regeneron's outstanding common stock and Class A stock, except under certain specified conditions. Sanofi's current ownership of Regeneron is 15.8M shares, representing approximately 16% of Regeneron's outstanding common stock and Class A stock.
News For REGN;SNY From The Last 14 Days
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January 30, 2015
06:55 EDTSNYSanofi having hard time finding new CEO, Reuters reports
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06:34 EDTREGNObama to propose $215M for major medical program, CNBC says
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January 29, 2015
09:07 EDTREGNHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
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January 26, 2015
05:14 EDTREGN, SNYRegeneron, 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 23, 2015
07:39 EDTREGNRegeneron announces EYLEA Injection recommended for approval in EU
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTREGN, SNYLeerink 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.

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