Key Developments: Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Sanofi Pasteur launches phase III clinical trial of candidate vaccine against ICD
Monday, 3 Feb 2014 03:01am EST 

Sanofi SA:Says its vaccines division Sanofi Pasteur has launched the phase III clinical trial of Cdiffense programme to evaluate the safety, immunogenicity and efficacy of a candidate vaccine for prevention of symptomatic primary infections against Clostridium difficile (ICD).Says Clostridium difficile is a potentially deadly bacteria causing intestinal diseases.Says that the phase III of Cdiffense clinical programme will consider15,000 adult volunteers and will be performed in 200 sites placed in 17 countries.  Full Article

Brower Piven files class action lawsuit against Sanofi SA
Friday, 31 Jan 2014 09:15pm EST 

Brower Piven:Announces that a class action lawsuit has been commenced in the United States District Court for the Southern District of New York on behalf of purchasers of Sanofi contingent value rights during the period between Mar. 6, 2012 and Nov. 7, 2013, inclusive.Says the complaint accuses Sanofi of failing to disclose that the its 323 and 324 trials for Lemtrada contained high levels of placebo effect and observer bias which tainted the results and thereby lowered the likelihood of Lemtrada being approved by the Food and Drug Administration.  Full Article

Sanofi SA files suit in The U.S. to defend patent rights on Lantus and Lantus SoloStar
Thursday, 30 Jan 2014 05:01pm EST 

Sanofi SA:Says that it filed a patent infringement suit against Eli Lilly and Company ( Lilly) on Jan. 30 in the United States District Court for the District of Delaware.Says in its suit Sanofi alleges infringement of four patents.Says suit was triggered by notifications received from Lilly beginning in mid-December, in which Lilly stated that it had filed a NDA (505(b)(2) New Drug Application) with FDA for an insulin glargine drug product.Says Lilly also stated that its NDA included a paragraph IV certification challenging six of the seven Sanofi patents listed in the FDA Orange Book for Sanofi's Lantus and Lantus SoloStar products.Says Lilly has also stated that it will not launch its product before the expiry of Sanofi's patent on the active ingredient in Lantus , which is in force through Feb. 12.  Full Article

Transgene SA and Sanofi SA launch construction phase of new bioproduction platform
Wednesday, 29 Jan 2014 01:30am EST 

Transgene SA and Sanofi SA:Say they have launched the construction phase of the manufacturing platform dedicated to the production of viral vectors, such as Transgene’s MUC1 targeted cancer immunotherapy, TG4010.Say the unit is to be constructed on the Genzyme Polyclonals site in Lyon.Say they will invest about 10 million euros in the production unit over an expected two-year timeframe, of which Transgene's share will be about 5 million euros.Say Sanofi, through its Genzyme Polyclonals site for the manufacturing and the CEPIA organization for commercial aspects, will act as Transgene’s Contract Manufacturing Organization (CMO) and Transgene will be considered as a preferred customer of the platform through 2028.Say this dedicated platform will be Sanofi’s exclusive property and will enable to produce a new class of APIs (Viral vectors).  Full Article

Pomerantz LLP files class action against Sanofi SA
Friday, 24 Jan 2014 05:36pm EST 

Pomerantz LLP:Says it has filed a class action lawsuit against Sanofi Pharmaceuticals, Inc. (Sanofi SA)and certain of its officers.Says the class action, filed in United States District Court, Southern District of New York is on behalf of all persons or entities who purchased Contingent Value Rights-2011 related to the performance of the company's anti Multiple Sclerosis drug Lemtrada between Mar. 6, 2012 and Nov. 7, 2013.Says the class action seeks to recover damages against the company and certain of its officers and directors as a result of alleged violations of federal securities laws.Says the complaint alleges that the defendants misrepresented to investors the efficacy and safety of Lemtrada.Says the complaint also alleges that Sanofi misled investors regarding the design of its two Lemtrada pivotal trials, the 323 and 324 trials, failing to disclose that the trials contained high levels of placebo effect and observer bias which lowered the likelihood of approval of Lemtrada by the FDA.Says on Nov. 8, 2013, the FDA Advisory Committee on Peripheral and Central Nervous System Drugs issued a briefing report in which it found that, "significant concerns exist regarding the safety profile of alemtuzumab [Lemtrada] and the adequacy of the efficacy data".Says that on this news, Sanofi's CVRs declined $1.23 per share or nearly 62 percent, to close at $0.77 on Nov. 8, 2013.  Full Article

Sanofi SA employees walk out in protest over salaries and jobs-AFP
Thursday, 23 Jan 2014 01:20pm EST 

Sanofi SA:Workers at Sanofi SA walked out on Jan. 23 to demand salary increases and commitments on job preservation-AFP.A representative of the CGT trade union said over 1,000 workers across six sites walked out.Sanofi put the number of employees involved at 650, and said eight sites were affected.  Full Article

Trade unions suspend blockade of Sanofi SA site but call for further industrial action-AFP
Tuesday, 21 Jan 2014 10:56am EST 

Sanofi SA:Workers protesting against the company's salary and employment policies suspended the blockade of the Marly-la-Ville (Val-d'Oise) site on Jan. 21, allowing medicines to leave-AFP.A member of the CGT trade union said the blockade would be lifted all day on Jan. 21 and Jan. 22.Blockades and walkouts had begun across France on Jan. 14, with workers demanding a collective pay rise and a commitment to keep existing sites open and maintain jobs.The CGT, CFDT and FO unions have called for further industrial action on Jan. 22 and Jan. 23, following a half-day strike in Toulouse.There are expected to be walkouts at the Sisteron (Alpes-de-Haute-Provence) and Ambares (Gironde) sites on Jan. 22, and walkouts at a dozen more sites on Jan. 23.  Full Article

Glancy Binkow & Goldberg LLP announces class action lawsuit on behalf of investors of Sanofi contingent value rights
Friday, 17 Jan 2014 09:32pm EST 

Glancy Binkow & Goldberg LLP:Says that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of a class comprising all purchasers of the contingent value rights (CVRs) of Sanofi SA between Mar. 6, 2012 and Nov. 7, 2013, inclusive (the class period).Says the complaint alleges that defendants knew or recklessly disregarded but failed to disclose that defendants had materially misrepresented the safety and efficacy of Lemtrada in statements to investors and the public.Says the design of the Lemtrada trials contained high levels of placebo effect and observer bias, which tainted the results and lowered the likelihood of FDA approval.Says the company lacked adequate internal controls and defendants lacked a reasonable basis for their positive statements about Lemtrada and its prospects.  Full Article

Zealand Pharma A/S announces advance by Sanofi SA of LixiLan towards Phase III development
Wednesday, 15 Jan 2014 11:04am EST 

Zealand Pharma A/S:Says under license agreement with Sanofi SA covering Lyxumia (lixisenatide) and any combination product including lixisenatide, an advance has been achieved of LixiLan, once-daily single injection Lantus/Lyxumia combination product, towards start of Phase III development in first quarter of 2014.Says the advance relates to the approval of the first Phase III study protocol for LixiLan by a Health Authority, triggering a $15 million payment to Zealand.Says Lixisenatide is a once-daily prandial GLP-1 receptor agonist invented by Zealand for the treatment of Type 2 diabetes.Says worldwide development and commercial rights to the product are exclusively licensed to Sanofi.Says the announced first LixiLan Phase III study protocol approval follows an update provided by Sanofi on Jan. 14 at the Annual J.P. Morgan Healthcare Conference, held in San Francisco, on the status of Lyxumia and LixiLan.Says that as part of the update, Sanofi confirmed plans to start Phase III development of LixiLan in the first quarter of 2014, narrowing its earlier guidance of an expected start in the first half of 2014.  Full Article

Sanofi SA and Fraunhofer-Gesellschaft announce the creation of a natural product center
Wednesday, 15 Jan 2014 01:00am EST 

Sanofi SA and Fraunhofer-Gesellschaft:Announce the creation of a natural product center to accelerate the discovery and development of new therapies to treat infectious diseases.Says that under the agreement, Sanofi and Fraunhofer IME (Institute for Molecular Biology and Applied Ecology) will collaborate to identify and optimize naturally occurring chemical or biological compounds, mainly in the field of infectious diseases.  Full Article

Sanofi to resubmit Lemtrada application for FDA review

PARIS, April 7 - Sanofi said it plans to resubmit its application for its Lemtrada drug for the treatment of relapsing forms of multiple sclerosis following "constructive discussions" with the U.S. Food and Drug Administration.

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