NEW YORK, Jan. 24, 2003 (PRIMEZONE) -- Wolf Popper LLP has filed a securities fraud lawsuit against Transkaryotic Therapies, Inc. ("TKT") (Nasdaq:TKTX), in the United States District Court for the District of Massachusetts, on behalf of persons who purchased TKT securities, or who sold put options, on the open market from January 4, 2001 through January 14, 2003.
The complaint alleges that during the Class Period, defendants made misrepresentations and nondisclosures of material fact to the investing public concerning TKT's prospects for FDA approval for the marketing of TKT's Replagal enzyme therapy for the treatment of Fabry disease.
In fact, the Complaint alleges, defendants knew by virtue of their ongoing communications with the FDA that the FDA considered TKT's data on the primary pain reduction endpoint of TKT's Phase II study to be uninterpretable, and further that the FDA considered that TKT's cardiac and renal data did not support approval.
More specifically, according to testimony at the January 14, 2003 Advisory Committee hearing, in a letter dated December 22, 2000, the FDA had advised TKT that "the clinical study data (from the Phase II studies) had not provided substantial evidence of efficiency and fully detailed the facts leading to that conclusion. (The FDA's Center for Biologics Evaluation and Research) recommended that additional clinical studies be conducted."
The true facts were first revealed after the close of the securities markets on October 2, 2002, when TKT admitted that the FDA had determined that TKT's data on pain reduction was "uninterpretable," and that TKT had determined not to rely on that data to seek FDA approval for marketing of Replagal. Rather, defendants stated that TKT would rely primarily on its data for cardiac and renal improvement in Phase II tests for patients receiving Replagal.
At the January 14, 2003 Advisory Committee meeting, the FDA further confirmed that it had informed TKT that the renal and liver data did not support approval as early as December 2000. On January 15, 2003, TKT closed at $6.49, more than 85% below its Class Period high.
TKT was motivated to make the materially false and misleading statements during the Class Period, among other things, to sell $267 million in common stock in secondary public offerings. Defendant Richard F. Selden was similarly motivated to sell 90,000 shares of his personal holdings of TKT common stock during the Class Period for total consideration of $2,800,000.
Class members who desire to be appointed a lead plaintiff in this action must file a motion with the Court no later than March 25, 2003. Class members who are interested in serving as a lead plaintiff in this action, or other persons who have questions or information regarding the prosecution of this action, are urged to call or write:
Wolf Popper LLP Robert C. Finkel, Esq. 845 Third Avenue New York, NY 10022 Tel.: 212.451.9620 Toll Free: 877.370.7703 Fax: 212.486.2093 Toll Free Fax: 877.370.7704 Email: irrep@wolfpopper.com website: www.wolfpopper.com
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca