PHILADELPHIA, Feb 19, 2002 (PRIMEZONE) -- Berger & Montague, P.C., (www.bergermonatague.com) filed a class action against ImClone Systems, Inc. (Nasdaq:IMCL) and two of its principal officers in the United States District Court for the Southern District of New York, on behalf of all persons or entities who purchased IMCL common stock during the period from May 12, 2001 through January 7, 2002.
The Complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 by making false and misleading statements regarding the Company's lead cancer drug, ERBITUX or IMC-C225 and the prospects for near-term approval of that drug for the treatment of colorectal cancer by the U.S. Food and Drug Administration ("FDA"). Among other things, (1) defendants repeatedly represented that ERBITUX was a blockbuster drug that would become "one of the important new drugs in the history of oncology;" (2) defendants told investors that ERBITUX would "be on the market next year" for the treatment of colorectal cancer, and that they were confident that the drug would be evaluated at the February 2002 meeting of the FDA Advisory Committee, stating: "We believe we'll be before the FDA Oncology Drug Advisory Committee in February and the drug should be approved shortly thereafter;" (3) defendants represented that the results of the Company's clinical trial of ERBITUX in the treatment of patients with colorectal cancer produced results that exceeded FDA requirements.
The Complaint alleges that these statements were materially false and misleading because, among other things (1) contrary to directives to the Company by the FDA, the trial was not designed to demonstrate that ERBITUX was responsible for the reported results; (2) the clinical trial on which the application was based was seriously flawed by the protocol violations, and was not "adequate and well controlled;" and (3) the safety database for the trial was incomplete and contained inconsistencies and discrepancies. As such, defendants knew or should have known that the FDA would refuse to file the Company's defective application, which would have a disastrous effect on the price of the Company's stock.
The Complaint further alleges that defendants made these false and misleading statements, in part, in order to convince Bristol-Myers Squibb Co. to purchase $1 billion of ImClone stock, of which approximately $150 million was tendered by ImClone insiders, including the Individual Defendants, and to persuade Bristol-Myers to make an additional $1 billion cash investment in the Company.
On December 28, 2001, ImClone shocked the market by issuing a press release that disclosed that the FDA had rejected its filing of a Biologics License Application ("BLA") for ERBITUX. ImClone's shares plummeted $11.15, or 20%, to $44.10. On January 4, 2002, a publication known as The Cancer Letter reported that ImClone was repeatedly informed about the problems with the clinical trials by the FDA during and before the Class Period. After these additional facts were disclosed, the price of ImClone stock fell further to open on January 7, 2002 at $34.96 per share.
On January 9, 2002, the Company issued a press release, which admitted that the Company "may need to conduct new trials of ... ERBITUX, potentially delaying the treatment's launch by months."
Counsel have conducted an extensive analysis of the facts underlying the Complaint. They have extensive experience in cases involving misrepresentations about clinical trials and about the efficacy and safety of drugs, having served as lead counsel in actions against Cephalon, Inc., Centocor, Inc., U.S. Bioscience, Synergen, Inc., and other such actions in which, substantial recoveries were obtained for class members. That experience is an important factor for the successful prosecution of these actions.
If you purchased IMCL common stock during the period from May 12, 2001 through January 7, 2002, inclusive, you may, no later than March 8, 2002, move to be appointed lead plaintiff. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery, is not, however, affected by the decision whether or not to serve as a lead plaintiff.
If you purchased IMCL common stock or have any questions concerning this notice or your rights with respect to this matter, you may contact :
Sherrie R. Savett, Esquire Carole A. Broderick, Esquire Kimberly A. Walker, Investor Relations Manager Berger & Montague, P.C. 1622 Locust Street Philadelphia, PA 19103 Phone: 888-891-2289 or 215-875-3000 Fax: 215-875-5715 Website: http://www.bergermontague.com e-mail: InvestorProtect@bm.net
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca