According to the law firm press release, Sanofi is a global pharmaceutical group engaged in the research, development, manufacture and marketing of healthcare products. Many of the Company's products are regulated by the United States Food and Drug Administration ("FDA"), which oversees the Company's compliance with applicable rules and regulates the Company's covered products such as vaccines and pharmaceuticals.
On or around February 16, 2011, Sanofi signed an agreement (the, "Merger Agreement") to acquire Genzyme Corporation ("Genzyme") and substantially all of Genzyme's assets. One of the most important drugs in development by Genzyme at the time of the acquisition was Lemtrada, a treatment for multiple sclerosis ("MS"). Sanofi (and Genzyme as its subsidiary) strongly touted the efficacy and safety of Lemtrada, by directing investors' attention to two pivotal studies which the Company claimed demonstrated the safety and efficacy of Lemtrada. In connection with the Genzyme acquisition, Sanofi agreed to amend the outstanding tender offer to acquire all of the outstanding shares of common stock of Genzyme (the "Genzyme Shares") in order to increase the price per share from $69.00 to $74.00 in cash plus one CVR to be issued by Sanofi, subject to and in accordance with a CVR Agreement, per Genzyme Share.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose the following: (a) that Defendants had materially misrepresented the safety and efficacy of Lemtrada in statements to investors and the public; (b) that the design of the Lemtrada 323 and 324 trials had been materially misrepresented to investors and the public, with Defendants failing to disclose that the trials contained high levels of placebo effect and observer bias, which tainted the results and thereby lowered the likelihood of Lemtrada approval by the FDA; (c) that the Company lacked adequate internal controls; and (d) that as a result of the foregoing, Defendants lacked a reasonable basis for their positive statements about Lemtrada and its prospects.
On November 8, 2013, the FDA Advisory Committee on Peripheral and Central Nervous System Drugs issued a briefing report (the "Briefing Report") in advance of its November 13, 2013 hearing. The Briefing Report sharply criticized the Company's submission to the FDA, and found that "significant concerns exist regarding the safety profile of alemtuzumab [Lemtrada] and the adequacy of the efficacy data." On this news, Sanofi's CVRs declined $1.23 per share, or nearly 62%, to close at $0.77 per share on November 8, 2013 on volume of over 30 million shares.
On March 3, 2014, the Court issued an Order consolidating cases, appointing lead plaintiff, and approving lead counsel.