Genta Misled Investors About the Safety of Its Drug to Treat Advanced Melanoma, Berger & Montague Alleges Tuesday May 4, 6:16 pm ET
PHILADELPHIA, May 4 /PRNewswire/ -- The law firm of Berger & Montague, P.C. (http://www.bergermontague.com) represents a purchaser of the common stock of Genta, Inc. ("Genta") (Nasdaq: GNTA - News) in a class action lawsuit against Genta and certain of its principal officers and directors in the United States District Court for the District of New Jersey on behalf of all persons or entities who purchased Genta securities between September 10, 2003 and May 3, 2004 (the "Class Period"), Maitland v. Genta, Inc., et al. (D.N.J.) The complaint alleges that defendants violated the federal securities laws by issuing materially false and misleading statements throughout the Class Period that had the effect of artificially inflating the market price of the Company's securities. Specifically, the complaint alleges that throughout the Class Period, defendants misrepresented the safety of the Company's drug, Genasense, for the treatment of advanced melanoma, the most deadly form of skin cancer.
During the Class Period, defendants falsely represented to the investing public that Genasense did not appear to be associated with serious adverse reactions in the Phase 3 clinical trial. In fact, defendants knew that the use of Genasense was associated with increased toxicity and discontinuations due to adverse events, and that U.S. Food and Drug Administration ("FDA") approval of the Genasense New Drug Application was unlikely because the increased toxicity and adverse events associated with the use of Genasense outweighed its marginal benefits.
On April 30, 2004, the staff of the Oncologic Drugs Advisory Committee (ODAC) of the FDA stated in briefing materials in advance of the May 3, 2004 ODAC meeting that the Phase 3 clinical trial of Genasense failed to demonstrate a survival benefit, which was the primary trial endpoint. However, small but unreliable benefits were seen for progression-free survival (PFS) and response rates (RR). The staff also stated: "Uncertainty also exists regarding whether an improvement in PFS and RR of this magnitude outweighs the increase in toxicity seen with the combination [of Genasense and dacarbazine.]: ... Survival was not improved and toxicity was increased." As a result of this announcement, the price of Genta shares dropped $5.83 or 40.4% to close at $8.60 on the Nasdaq market on an unusually high volume of over 30 million shares traded.
On May 3, 2004, the ODAC ruled by a 13-3 vote that, in the absence of increased survival, the evidence presented did not provide substantial evidence of effectiveness to outweigh the increased toxicity of Genasense. As a result of this announcement, the price of Genta shares fell more than $3 per share, to close at $5.11 on May 3, 2004 at a high volume of over 17 million shares traded.
If you purchased Genta securities during the period from September 10, 2003 through May 3, 2004, inclusive, you may, no later than July 5, 2004, move to be appointed as a Lead Plaintiff. A Lead Plaintiff is a representative party that acts on behalf of other class members in directing the litigation. The Private Securities Litigation Reform Act of 1995 directs courts to assume that the class member(s) with the "largest financial interest" in the outcome of the case will best serve the class in this capacity. Courts have discretion in determining which class member(s) have the "largest financial interest," and have appointed Lead Plaintiffs with substantial losses in both absolute terms and as a percentage of their net worth. If you have sustained substantial losses in Genta securities during the Class Period, please contact Berger & Montague, P.C. at investorprotect@bm.net for a more thorough explanation of the Lead Plaintiff selection process.
The law firm of Berger & Montague, P.C. has over 60 attorneys, all of whom represent plaintiffs in complex litigation. The firm has special expertise in cases involving misrepresentations concerning the efficacy and safety of drugs. For example, the firm has served as lead or co-lead counsel in numerous class actions against drug companies, including U.S. Bioscience, Inc., Synergen, Inc., Centocor, Inc., Cephalon, Inc., Cell Pathways, Inc., Genentech, Inc. and Viropharma, Inc.
The Berger firm has extensive experience representing plaintiffs in class action securities litigation and has played lead roles in major cases over the past 25 years which have resulted in recoveries of several billion dollars to investors. The firm has represented investors as lead counsel in such leading securities actions as Rite Aid, Sotheby's, Waste Management, Inc., Sunbeam, Boston Chicken and IKON Office Solutions, Inc. The standing of Berger & Montague, P.C. in successfully conducting major securities and antitrust litigation has been recognized by numerous courts. For example:
"Class counsel did a remarkable job in representing the class interests." In Re: IKON Office Solutions Securities Litigation. Civil Action No. 98-4286(E.D.Pa.) (partial settlement for $111 million approved May, 2000).
"...[Y]ou have acted the way lawyers at their best ought to act. And I have had a lot of cases ... in 15 years now as a judge and I cannot recall a significant case where I felt people were better represented than they are here ... I would say this has been the best representation that I have seen." In Re: Waste Management, Inc. Securities Litigation, Civil Action No. 97-C 7709 (N.D. Ill.) (settled in 1999 for $220 million).
If you purchased Genta securities during the Class Period, please visit our website at www.bergermontague.com to view the complaint and join the class action or if you have any questions concerning this notice or your rights with respect to this matter, please contact:
Sherrie R. Savett, Esquire Carole A. Broderick, Esquire Barbara A. Podell, Esquire Diane R. Werwinski, 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: bergermontague.com e-mail: InvestorProtect@bm.net |