Key Developments: Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Sanofi to propose share repurchase program
Sunday, 13 Apr 2014 08:00pm EDT 

Sanofi SA:To propose terms of share repurchase program to annual general meeting.Program would authorize repurchase of up to 10 pct of capital.Maximum price per share 100 euros.Total maximum that could be spent 13,243,208,800 euros.Authorization valid for 18 months.  Full Article

Sanofi SA to Resubmit Lemtrada application for FDA review
Monday, 7 Apr 2014 01:15am EDT 

Sanofi SA:Announced that following constructive discussions with the U.S. Food and Drug Administration (FDA).Company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.The resubmission will provide information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter.  Full Article

Merck and Sanofi Pasteur Gardasil approved in EU-PR Newswire Europe
Sunday, 6 Apr 2014 08:00pm EDT 

Sanofi SA:European Commission grants marketing authorization for quadrivalent Human Papillomavirus (HPV) vaccine Gardasil developed by Sanofi Pasteur and Merck & Co Inc joint venture Sanofi Pasteur MSD - PR Newswire Europe.Authorization is granted for 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.Approval of this new schedule for Gardasil follows positive opinion from European Medicines Agency (EMA) granted in February, based on Canadian study performed by Dobson et al.Study demonstrated that 2-dose 0, 6 month schedule in 9-13 year old girls elicited immune response comparable/non-inferior to that of 3 doses in 16-26 year old women, population where quadrivalent vaccine efficacy has been shown.Results were sustained at 36 months of follow-up.  Full Article

Sanofi SA and Regeneron report positive results with Alirocumab from Phase 2 Japanese study
Tuesday, 1 Apr 2014 08:06am EDT 

Sanofi SA And Regeneron Pharmaceuticals Inc:Says that the first Phase 2 study with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), in Japanese patients met its primary endpoint.The results demonstrated that the mean low-density lipoprotein-cholesterol (LDL-C, or bad cholesterol) percentage reduction from baseline to week 12.The primary efficacy endpoint of the study, was significantly greater in patients randomized to receive one of three doses of alirocumab administered every other week (Q2W) -- 150 milligrams (mg), 75 mg, and 50 mg, in combination with statin therapy, compared to patients receiving placebo.  Full Article

Sanofi SA's Genzyme announces Lemtrada Approves in Brazil for treatment of multiple Sclerosis
Friday, 21 Mar 2014 08:00am EDT 

Genzyme, a Sanofi company:Brazil's national health surveillance agency, ANVISA, has approved Lemtrada (alemtuzumab).For treatment of patients with relapsing forms of multiple sclerosis (MS) to slow or reverse accumulation of physical disability and reduce the frequency of clinical exacerbations.Lemtrada is innovative treatment, with clinical trial data that support its potential to meaningfully address relapse rates and disability in patients with active MS.Lemtrada is supported by comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.  Full Article

Sanofi launches MyStarExtra in U.K.-PR Newswire Europe
Wednesday, 19 Mar 2014 08:00pm EDT 

Sanofi SA:MyStarExtra, new generation blood glucose monitoring device developed by Sanofi, becomes available in United Kingdom - PR Newswire Europe.MyStar Extra is self-monitoring device that provides estimates of the HbA1c value, key indicator for long-term glucose control.  Full Article

Sanofi Pasteur allies with SK Chemical Co on pneumococcal conjugate vaccine
Wednesday, 19 Mar 2014 02:00am EDT 

Sanofi SA:Says its vaccines division Sanofi Pasteur is cooperating with SK Chemical Co Ltd to co-develop a pneumococcal conjugate vaccine (PCV).Collaboration agreement includes research & development, production, and commercialization of preventative pneumococcal disease vaccine.Sanofi will make an up-front payment of $23 million to SK Chemical Co.Both companies will co-invest in the development of the PCV vaccine project and, if successful, SK Chemical would produce vaccine at its production facility located in An-dong, South Korea.Product, once registered, would be launched globally by Sanofi Pasteur with shared profits outside of Korea, where SK would commercialize it with exclusive rights.  Full Article

Sanofi teams up with UCB for research in immune-mediated diseases
Tuesday, 11 Mar 2014 02:01am EDT 

Sanofi SA:Enters into strategic collaboration with UCB for discovery and development of anti-inflammatory small molecules to treat wide range of immune-mediated diseases in areas such as gastroenterology and arthritis.Costs and profits shared 50/50.UCB entitled to initial upfront, preclinical and clinical development milestone payments from Sanofi, potentially above 100 million euros.  Full Article

Genfit SA updates on research collaboration with Sanofi SA
Monday, 3 Mar 2014 11:45am EST 

Genfit SA:Announces demonstration of beneficial effects of several molecules in various in vivo models related to diseases targeted in its research collaboration with Sanofi SA.Development comes within co-research contract signed between Genfit and Sanofi to develop new medicines to correct mitochondrial dysfunction associated with certain metabolic disorders, in particular Type 2 diabetes.In accordance with the terms of the contract, whereby Sanofi obtained the exclusive worldwide rights to develop and commercialize the molecules arising from the research collaboration, Genfit has received the third of the milestone payments included in the collaboration and licensing agreement.Depending on preclinical and clinical development, and registration and commercialization of resulting products, Genfit's milestone payments included in the agreement could reach $54 million.  Full Article

Sanofi SA sues Actavis PLC over generic version of Multaq-Reuters
Friday, 28 Feb 2014 12:28pm EST 

Sanofi SA:Sues generic drugmaker Actavis PLC over alleged patent infringements on its heart drug Multaq-Reuters.The suit alleges infringement of three United States patents on Multaq, a Sanofi spokeswoman said.The suit automatically triggered a stay of approval by the FDA, keeping the generic product off the U.S. market until Jan 1, 2017.  Full Article

IATA seeks meeting with Venezuela president over money owed to airlines

BERLIN, July 28 - A leading air transport industry body has called for a top-level meeting with the Venezuelan president to discuss ways to restore over $4 billion of airlines' money that is trapped in the country due to its currency controls.

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