NEW YORK, March 16, 2005 (PRIMEZONE) -- Pomerantz Haudek Block Grossman & Gross LLP (www.pomerantzlaw.com) filed a class action lawsuit on March 8, 2005 in the United States District Court for the Southern District of New York, against AstraZeneca PLC ("AstraZeneca" or the "Company") (NYSE:AZN) and certain of its executive officers and directors, for violations of the Securities Exchange Act of 1934. The class period in this case is April 2, 2003 to October 8, 2004.
AstraZeneca is a pharmaceutical company which researches, develops, manufactures and markets prescription pharmaceuticals and the supply of healthcare services. The complaint alleges that during the class period, the company engaged in late-stage clinical trials of an oral anticoagulant, Exanta(R), also generically known as Ximelagatran, to study the prevention and treatment of blood clots. During the Class Period, AstraZeneca touted the purportedly positive results from the clinical trials of Exanta, claiming that they were indicative of a safe and effective new direct oral anticoagulant. In December 2003, after completion of the clinical trials, AstraZeneca issued a press release announcing its submission of a New Drug Application ("NDA") to the FDA for approval to market Exanta. Defendants made numerous positive statements at investor and analyst conferences about the status of the NDA, and repeatedly commented that FDA approval of the application would positively and materially impact the Company's financial results. The truth began to emerge on September 9, 2004 when the FDA posted on its website briefing documents in preparation for its Cardiovascular and Renal Drugs Advisory Committee meeting on September 10, 2004 where the Company's NDA was scheduled to be reviewed. The briefing documents revealed previously undisclosed adverse events in the Exanta Studies. On September 10, 2004, at the FDA Cardiovascular and Renal Drugs Advisory Committee meeting, the team leader in the FDA's Division of Gastrointestinal and Coagulation Drug Products, presented the FDA's first risk/benefit assessment of Exanta. The FDA assessment raised numerous alarming safety and efficacy issues in the Exanta trials. At the September 10, 2004 FDA Advisory Committee Meeting, a Medical Officer of the FDA's Division of Drug Risk Evaluation, presented the FDA's Risk Assessment/Risk Management of EXATA(R) (ximelagatran) Livery Injury. The officer stated that "the projected rate of liver failure, transplant, or liver-associated death with Ximelagatran is 10 percent of 1 in 200 or 1 in 2,000 ... Ximelagatran can cause severe and even fatal liver injury in some patients."
In reaction to this news, the price of AstraZeneca began to decline falling from $44.40 on September 9,2004 to $38.68 on October 8, 2004, the date the company issued a press release announcing that it received an Action letter from the FDA rejecting the Exanta NDA.
If you purchased the securities of AstraZeneca PLC during the Class Period, you have until March 28, 2005 to ask the Court to appoint you as lead plaintiff for the Class. Lead plaintiffs must meet certain legal requirements. Shareholders outside the United States may also join the action, regardless of where they live or which exchange was used to purchase the securities. If you wish to review a copy of the Complaint, to discuss this action, or have any questions, please contact Teresa L. Webb (tlwebb@pomlaw.com or Carolyn S. Moskowitz (csmoskowitz@pomlaw.com) of the Pomerantz Firm at 888.476.6529 (or 888.4-POMLAW), toll free. Those who inquire by e-mail are encouraged to include their mailing address and telephone number.
The Pomerantz Firm, which has offices in New York, Chicago and Washington, D.C., is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 50 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. For more information about the Firm, visit our web site at www.pomlaw.com.