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Case Status:    ONGOING    
On or around 12/11/2013 (Ongoing date of last review)

Filing Date: December 11, 2013

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.

COMPANY INFORMATION:

Sector:
Industry:
Headquarters: United States

SECURITIES INFORMATION:

Ticker Symbol: GCVRZ
Company Market: NASDAQ
Market Status: Public (Listed)

About the Company & Securities Data


"Company" information provides the industry and sector classification and headquarters state for the primary company-defendant in the litigation. In general, "Securities" information provides the ticker symbol, market, and market status for the underlying securities at issue in the litigation.

In most cases, the primary company-defendant actually issued the securities that are the subject of the litigation, and the securities information and company information relate to the same entity. In a small subset of cases, however, the primary company-defendant is not the issuer (for example, cases against third party brokers/dealers), and the securities information and company information do not relate to the same entity.
COURT: S.D. New York
DOCKET #: 13-CV-08806
JUDGE: Hon. Paul A. Engelmayer
DATE FILED: 12/11/2013
CLASS PERIOD START: 03/06/2012
CLASS PERIOD END: 11/07/2013
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Harwood Feffer LLP
    488 Madison Avenue 8th Floor, Harwood Feffer LLP, NY 10022
    212.935.7400 212.753.3630 · info@whhf.com
  2. Ryan & Maniskas, LLP
    995 Old Eagle School Rd., Ste. 311, Ryan & Maniskas, LLP, PA 19087
    (484) 588-5516 (484) 450-2582 ·
  3. The Weiser Law Firm, P.C.
    121 N. Wayne, Ave, Suite 100, The Weiser Law Firm, P.C.
    610.667.7706 · rw@weiserlawfirm.com
No Document Title Filing Date
COURT: S.D. New York
DOCKET #: 13-CV-08806
JUDGE: Hon. Paul A. Engelmayer
DATE FILED: 04/28/2014
CLASS PERIOD START: 03/06/2012
CLASS PERIOD END: 11/07/2013
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Harwood Feffer LLP
    488 Madison Avenue 8th Floor, Harwood Feffer LLP, NY 10022
    212.935.7400 212.753.3630 · info@whhf.com
  2. Ryan & Maniskas, LLP
    995 Old Eagle School Rd., Ste. 311, Ryan & Maniskas, LLP, PA 19087
    (484) 588-5516 (484) 450-2582 ·
  3. The Weiser Law Firm, P.C.
    121 N. Wayne, Ave, Suite 100, The Weiser Law Firm, P.C.
    610.667.7706 · rw@weiserlawfirm.com
No Document Title Filing Date