Key Developments: Sanofi SA (SNY)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Sanofi SA Announces Reorganization of Research Activities in France
Sanofi SA announced that it has confirmed its intent to regroup its research activities in France in the regions of Paris and Lyon, in Strasbourg and to transform the Montpellier R&D site into a strategic development center for the Company. The Company also intends to transform the structures of the site in Toulouse, so that it keeps a scientific and technological mission, and to safeguard a maximum number of jobs in the region. Based on the options considered in a report, Sanofi will explore the following: the creation of a technological platform to provide services for Sanofi and other biotechnological or pharmaceutical companies; the spin-off of activities dedicated to the development of innovative therapeutic solutions; and the establishment of local start-ups on the site. In addition, as already announced, the anti-infectious research of the site will be moved to Lyon. Full Article
Sanofi SA Announces Positive Results on Pivotal Study of Inhibitor in Myelofibrosis-DJ
Dow Jones reported that Sanofi SA announced a pivotal study examining JAK2 inhibitor SAR302503 for myelofibrosis (MF) had positive results. The primary endpoint assessed the proportion of patients achieving less than 35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, nausea and vomiting. Full results will be presented at an upcoming medical congress. MF is a rare, debilitating and life-threatening hematologic malignancy characterized by abnormal blood cell production and scarring, or fibrosis, in the bone marrow. SAR302503 is an investigational, selective JAK2 inhibitor. The Company's Sanofi Oncology is developing SAR302503 for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia. Full Article
Sanofi SA and Regeneron Pharmaceuticals Inc Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis
Sanofi SA and Regeneron Pharmaceuticals Inc announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, have enrolled their first patients. The broad SARIL-RA clinical development program is focused on adult populations with moderate to- severe rheumatoid arthritis (RA) who are inadequate responders to either methotrexate (MTX) or tumor necrosis factor alpha (TNF-alpha) inhibitor therapy. The SARIL-RA program is comprised of the following five trials: SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARILRA ASCERTAIN, and an open-label extension trial, SARIL-RA EXTEND. The program is targeted to enroll approximately 2,600 patients with moderate-to-severe rheumatoid arthritis. The primary objective of the overall Phase 3 program is to determine the safety and efficacy of sarilumab in reducing the signs and symptoms of RA, as well as inhibiting disease progression, in a broad range of patients. Two doses of sarilumab are being studied in the SARIL-RA program: 150 milligrams (mg) every other week and 200mg every other week. The SARIL-RA ASCERTAIN trial is a multi-center, randomized, double-blind, active-calibrator, Phase 3 trial of 24 weeks that will assess the safety and tolerability of sarilumab and tocilizumab. Full Article
Sanofi SA Fined EUR 40.6 Million by French Competition Authority in Plavix Dispute-Reuters
Reuters reported that the French Competition Authority said it fined Sanofi SA EUR 40.6 million over what it called a smear campaign aimed at stifling generic competition to its blood thinner, Plavix. The decision follows a complaint filed by Teva Sante, a unit of Israel-based Teva Pharmaceutical Industries, against communication practices by Sanofi SA towards health professionals to limit the use of generic versions of Plavix and support its own products, Plavix Princeps and Plavix Clopidogrel Winthrop. Sanofi SA told Reuters that it was planning to appeal against the ruling. Full Article
Sanofi SA Confirms FY 2013 EPS Guidance-Reuters
Reuters reported that Sanofi SA confirmed that its expects earnings per share (EPS) for fiscal year 2013 to be flat to 5% lower than in fiscal year 2012, as it had been announced on February 7, 2013. According to I/B/E/S Estimates, analysts on average were expecting the Company to report fiscal year 2013 EPS of EUR 6.23. Full Article
NextBio Announces Translational Medicine Partnership with Sanofi SA
NextBio announced a multi-year collaboration with Sanofi SA, aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi SA's drug research and development, as part of Sanofi SA's Translational Medicine for Patients (TM4P) program. NextBio will provide Sanofi SA with the NextBio Clinical platform for aggregation, standardization and analysis of patient clinical data, next generation sequencing (NGS) and other molecular data across public data sources, Sanofi SA clinical trials and Sanofi SA hospital partners. NextBio's data integration platform, user interface and real-time Big Data analytics will allow Sanofi SA biologists and clinicians to tap into a growing collection of patient data. Full Article
Sanofi SA's Genzyme Announces Results TOPIC Study into Aubagio
Sanofi SA's Genzyme announced positive top-line results from the TOPIC trial for AUBAGIO (teriflunomide). The trial was designed to assess whether early initiation of AUBAGIO (teriflunomide) in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS). In the TOPIC trial, patients receiving AUBAGIO 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo. Additional results, including key secondary and tertiary objectives, will be presented at a forthcoming scientific meeting. Primary results were: in patients who received AUBAGIO 14 mg, a 43% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (p=0.0087); in patients who received AUBAGIO 7 mg, a 37% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (p=0.0271). Full Article
Sanofi SA's Sanofi Pasteur Announces the European Commission Approval for HexyonTM/Hexacima Vaccine
Sanofi SA's Sanofi Pasteur announced that the European Commission approved the Company's pediatric vaccine 6-in-1 HexyonTM/Hexacima (vaccine DTCa-IPV-Hib-HepB) for primo-vaccination and secondary vaccination od children from the age of six weeks. HexyonTM/Hexacima is a 6-in-1 vaccine, 100% liquid, protecting the infants from diphtheria, tetanus, whooping cough, poliomyelitis, hepatitis B and the invasive infections caused by type b Haemophilus influenzae. The new vaccine will be marketed as Hexyon in the Western-Europe countries and as Hexacima in the Eastern-Europe countries. Full Article
Sanofi SA Inaugurates Logistics Platform in Morocco
Sanofi SA announced the inauguration of its new logistics platform in Casablanca, Morocco. The platform, worth EUR 20 million, was inaugurated in the presence of Mr. Christopher A. Viehbacher, the Company's Chief Executive Officer, Mr. El Aid, General Secretary of the Department for Foreign Trade at the Ministry of Commerce, Industry and New TTechnologies, and Mr. El Houssaine Louardi, Minister of Health of the Kingdom of Morocco. Full Article
Sanofi SA Announces Participation in French-German Advanced Translational Drug Discovery Center
Sanofi SA announced the signature of memoranda of understanding towards the creation of the French-German Advanced Translational drug discovery Center (FGATC). The French-German Advanced Translational drug discovery Center is a project of public private partnership, in which Sanofi SA would partner with INSERM, the University of Strasbourg, the Mannheim Medical Faculty of the University of Heidelberg and the German Cancer Research Centre (DKFZ). The objective would be to share resources and experiences across the various entities in order to translate biomedical research into new therapies. The location would be planned on two sites in Strasbourg and Heidelberg/Mannheim. Full Article
REFILE-Sanofi says will back overhaul of Toulouse research site
(Changes 'keep' to 'back overhaul of' in headline; changes wording of paragraph 7 to remove reference to retaining site)
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