Key Developments: Sanofi SA (SASY.PA)

SASY.PA on Paris Stock Exchange

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11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Sanofi Pasteur announces publication of dengue vaccine Asian efficacy study results
Thursday, 10 Jul 2014 07:03pm EDT 

Sanofi SA:Vaccines division Sanofi Pasteur announces publication in The Lancet of detailed results of its first phase III dengue vaccine efficacy study conducted in five countries in Asia.Results show overall efficacy against symptomatic dengue of 56.5 pct in children aged 2 to 14 years old after three-dose vaccination schedule.Analyses show 88.5 pct reduction of dengue haemorrhagic fever, severe form of dengue, according to WHO criteria.Study also shows clinically important reduction in risk of hospitalization due to dengue by 67 pct during study.Results to be supplemented by results from second, large-scale phase III study in Latin America and Caribbean, including more than 20,000 children and adolescents aged 9 to 16 years old from Brazil, Colombia, Honduras, Mexico and Puerto Rico.  Full Article

Regeneron and Sanofi announce positive results from phase 2b study of dupilumab in patients with moderate-to-severe atopic dermatitis
Wednesday, 9 Jul 2014 05:00pm EDT 

Regeneron Pharmaceuticals Inc:Says that the company and Sanofi announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema.All doses of dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo.Dupilumab is an investigational monoclonal antibody that blocks signaling of IL-4 and IL-13, two cytokines that play a key role in the pathogenesis of moderate-to-severe atopic dermatitis.  Full Article

FDA accepts for review Sanofi SA new drug application for Basal Insulin Toujeo
Tuesday, 8 Jul 2014 01:01am EDT 

Sanofi SA:Announces that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo (insulin glargine (rDNA origin) injection, 300 U/mL), an investigational basal insulin.The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27.  Full Article

Sanofi files patent infringement lawsuit against Eli Lilly-Reuters
Monday, 7 Jul 2014 08:00pm EDT 

Sanofi SA:Files lawsuit accusing Eli Lilly and Co of infringing seven patents related to insulin and devices used to deliver it - Reuters.Seeks to halt Lilly's proposed commercial marketing in United States of treatment known as Abasria.Lawsuit follows narrower lawsuit filed in January, after Lilly and German partner Boehringer Ingelheim Corp applied with U.S. FDA to sell generic version of Sanofi's Lantus, whose active ingredient is insulin glargine.  Full Article

Sanofi Canada launches new insulin pen JuniorSTAR
Wednesday, 2 Jul 2014 09:47am EDT 

Sanofi SA:Sanofi Canada launches new insulin pen JuniorSTAR, designed to help young people with type 1 diabetes through process of self-inject.JuniorSTAR is available across Canada and its features include possibility to adjust doses in half-units, two different colors to help avoid insulin mix-up, as well as single step dial-back, among others.  Full Article

Sanofi SA's Genzyme receives approval for Lemtrada in Argentina for treatment of Multiple Sclerosis
Monday, 30 Jun 2014 08:00am EDT 

Genzyme:Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved Lemtrada (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.Lemtrada is supported by comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.In addition to Argentina, Lemtrada is approved in European Union, Australia, Canada, Mexico, Brazil and Guatemala.Lemtrada is not approved in the United States.Genzyme recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's resubmission of its application seeking approval of Lemtrada.Genzyme expects FDA action on application in fourth quarter.Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease.Says were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as ongoing extension study.In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance.Genzyme, a Sanofi SA company.  Full Article

Dubai Investments PJSC divests 66 per cent stake in Globalpharma Co LLC to Sanofi SA
Thursday, 26 Jun 2014 04:22am EDT 

Dubai Investments PJSC (DI):Announces the divestment of 66 per cent equity stake in its pharmaceutical subsidiary, Globalpharma Co LLC.Says the Group will continue to hold 34 per cent equity in Globalpharma Co LLC, and the transaction yielded a healthy IRR of 26 per cent over a 10-year period for DI.Announces that the DI has divested 66 per cent to the investor group led by Sanofi SA.Says pursuant to the agreements entered into between DI and the investor group, Globalpharma Co LLCwill be managed as a Sanofi SA company and will become the platform to manufacture and promote the generics portfolio of Sanofi SA in the Middle East markets.  Full Article

Sanofi SA's Lyxumia (lixisenatide) showed more pronounced after-test-meal blood sugar lowering than liraglutide when both were added to insulin glargine
Sunday, 15 Jun 2014 01:02pm EDT 

Sanofi SA:Announces that Lyxumia (lixisenatide) met primary endpoint in an 8-week head-to-head pharmacodynamic study versus liraglutide.Showing significantly more pronounced post-prandial (after-meal) glucose (blood sugar) lowering effect after a test-meal than liraglutide when both were added to optimally titrated Lantus (insulin glargine).Lowering of post-prandial glucose was measured as change from baseline in incremental area under glucose curve for four hours after standardized solid breakfast, at week 8.Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment resulted in fewer reports of gastrointestinal adverse events.A lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels.Most commonly reported adverse events in study were symptomatic hypoglycemia and nausea.Symptomatic hypoglycemia was more frequent in the lixisenatide group compared to the liraglutide group.Lixisenatide is currently approved in Europe and an investigational drug in the United States, where it is not approved.  Full Article

Sanofi SA announces positive phase 3 results for Toujeo
Saturday, 14 Jun 2014 01:01pm EDT 

Sanofi SA:Says that, in a pooled analysis, investigational therapy Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) consistently showed significantly fewer low blood sugar events (hypoglycemia).At any time of day, including night-time events, compared with Lantus(R) (insulin glargine [rDNA origin] injection, 100 U/mL).Pooled analysis comprised data from three differing type 2 patient populations.In this analysis, more pronounced, significant reductions in low blood sugar rates at any time of day, including nighttime, were observed with Toujeo during the 8-week titration period when compared with Lantus.  Full Article

Sanofi SA and Medtronic Inc to form strategic alliance in diabetes to improve patient experience and outcomes
Saturday, 14 Jun 2014 10:00am EDT 

Sanofi Sa and Medtronic Inc:Sign memorandum of understanding to enter into global strategic alliance in diabetes, aimed at improving patient experience and outcomes for people with diabetes around world.Alliance will initially focus on two key priorities: development of drug-device combinations and delivery of care management services to improve adherence, simplify insulin treatment, and help people with diabetes better manage their condition.Alliance will be structured as open-innovation model, leveraging the capabilities, as well as human and financial resources, of both companies.Based on success of the two initial priorities, companies may explore other areas for potential collaboration.  Full Article

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Sanofi dengue vaccine promising but questions remain

PARIS - The first vaccine against dengue fever, from France's Sanofi, provided moderate protection in a large clinical study, but questions remain as to how well it can help fight the world's fastest-growing tropical disease. | Video

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