Key Developments: Sanofi SA (SASY.PA)
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Latest Key Developments (Source: Significant Developments)
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
Sanofi SA's Sanofi Pasteur Announces Acceptance of Quadrivalent Influenza Vaccine for Review for European Approval
Sanofi SA's Sanofi Pasteur announced that a decentralized marketing authorization application has been accepted for review in the European Union countries for a quadrivalent (four-strain) formulation of Vaxigrip Sanofi Pasteur’s seasonal inactivated split-virion influenza vaccine produced at its facility in Val de Reuil, France. The file has been accepted for review by France’s Agence nationale de securite du medicament et des produits de sante (ANSM) as the regulatory agency for the “Reference Member State”, and by national regulatory agencies from the EU countries. Full Article
Sanofi SA's Genzyme Once-daily, Oral AUBAGIO Approved In Argentina For Treatment Of Relapsing Multiple Sclerosis
Genzyme, a Sanofi SA company announced Argentina`s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The decision by ANMAT represents the first approval for once-daily, oral AUBAGIO in Latin America. AUBAGIO is also approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world. The ANMAT approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years. AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Full Article
Sanofi SA Prices USD 1.5 Billion Bond Issue
Sanofi SA announced that it has priced its offering of USD 1.5 billion of notes denominated in United States dollars, due April 10, 2018, bearing interest at an annual rate of 1.25%. BofA Merrill Lynch, Barclays, Deutsche Bank and J.P Morgan acted as joint book-running managers for the offering. Credit Agricole CIB, Citi and HSBC were co-lead managers for the offering. Full Article
Sanofi SA Launches Construction Project of New Manufacturing Facility in Vietnam
Sanofi SA announced the official launch of a construction project for a new manufacturing facility in the Saigon High Tech Park - Ho Chi Minh City. The new plant will expand the Company's manufacturing capacity in Vietnam to meet the fast growing demand of the Vietnamese pharmaceutical market and will serve as an export platform to ASEAN countries. The investment in this new plant will amount to USD 75 million and will constitute the Company's largest investment in Vietnam to date. With an initial capacity of 90 million units per year, and a possible extension up to 150 million units, the facility will produce pharmaceuticals and consumer healthcare products. The plant is scheduled to be fully operational by the end of 2015. Full Article
Moody's Upgrades Sanofi SA to A1-Reuters
Reuters reported that Moody's Investors Service upgraded to A1 from A2 the long-term senior unsecured ratings of Sanofi SA and its affiliates. It has, at the same time, upgraded to (P)A2 from (P)A3 its subordinate MTN debt rating. The Company's Prime-1 (P-1) short-term ratings are unchanged. The outlook on all ratings is stable. The Company's A1 rating positively reflects its scale and position in pharmaceuticals, vaccines and animal health, its diversification in multiple therapeutic areas, as well as other health-related areas (e.g., over-the-counter and branded generics), reinforced by the acquisition of Genzyme, its gradual transition to a business profile less exposed to the impact of patent expiries and also its cash flow generation combined with the liquidity profile. Full Article
Sanofi SA and Transgene SA Announce New Long-Term Joint Venture for Production of Immunotherapy Treatments
Sanofi SA and Transgene SA announced the collaboration agreement for the creation of a new industrial platform dedicated to the production of immunotherapy products including Transgene SA's therapeutic products. The joint venture platform will be realized on Genzyme Polyclonals site in Lyon - Gerland area for an investment amount of EUR 1.000 million equally financed by Sanofi SA and Transgene SA. The Platform will remain Sanofi SA's exclusive property. Accordingly, Sanofi SA and Genzyme are expected to act as Transgene SA's Contract Manufacturing Organization (CMO) to manufacture clinical and commercial batches of drug substance of Transgene SA's immunotherapy products, including its MVA1 therapeutic vaccines. Transgene SA will be a preferred customer of the commercial manufacturing platform for 15 years. Genzyme Polyclonals site in Lyon – Gerland area – is manufacturing polyclonal antibodies for the worldwide markets. Construction, qualification and validation of the manufacturing suite is to start in Q3 of the year 2013 and should be completed in Q1 of the year 2015. First batches of commercial grade products from the suite are expected in 2015. Transgene SA expects to file its first BLA2 in 2016. Full Article
Sanofi SA's Genzyme Receives Positive CHMP Opinion In European Union For Once-daily, Oral AUBAGIO To Treat Relapsing-Remitting Multiple Sclerosis
Sanofi SA's Genzyme announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of once-daily, oral AUBAGIO (teriflunomide) for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS). The CHMP did not recommend that AUBAGIO receive a new active substance (NAS) designation. Full Article
Sanofi SA Receives Positive Recommendation from European Medicines Agency
Sanofi SA announced that its Aubagio for multiple sclerosis received positive recommendation from the European Union. 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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