NEW YORK, Dec. 4, 2003 (PRIMEZONE) -- The Law Firm of Wechsler Harwood LLP announced today that a class action lawsuit has been filed on behalf of purchasers of Alkermes, Inc. ("Alkermes" or the "Company") (Nasdaq:ALKS) common stock between April 22, 1999 and July 1, 2002, inclusive (the "Class Period").
The action, entitled Folkerts v. Alkermes, Inc., et al., 1:03-CV---(RCL), is pending in the United States District Court for the District of Massachusetts against Alkermes and certain of its senior officers and directors. A copy of the complaint is available from the Court or can be viewed on the firm's website at www.whesq.com.
The complaint charges that Alkermes, Richard F. Pops, Robert A. Breyer, David A. Broecker, Michael J. Landine, James M. Frates and James L. Wright violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, by issuing a series of material misrepresentations about the Company's New Drug Application ("NDA") for Risperdal Consta to the market between April 22, 1999 and July 1, 2002, thereby artificially inflating the price of Alkermes' common stock.
The true facts, which were known by each of the defendants during the Class Period but were concealed from the investing public, were as follows: (a) In an attempt to decrease development expenses and speed the product to market, defendants concealed the deficient nature of the manufacturing process for Medisorb polylactide-glycolide polymer used to manufacture Risperdal Consta, resulting in quality management issues and delays in the development program; (b) in order to conceal lot-to-lot variations resulting from the manufacturing process for Medisorb polymer, defendants minimized process development and validation requirements, including the establishment of specifications and analytical tests necessary to control those variations; (c) significant quality issues for the manufacture of Risperdal Consta existed at the Wilmington, Ohio facility, impacting the ability of the Company to meet clinical development timelines for Risperdal Consta; (d) in order to avoid disclosure of the serious deficiencies of the Medisorb manufacturing process, particularly the lot-to-lot variation in molecular weight for Medisorb polymer, and in order to find a way to fix the desired molecular weight of the Risperdal Consta finished drug product, defendants patented a method to degrade the finished product to the desired molecular weight; (e) defendants' revenue projections for Risperdal Consta were grossly inflated based on defendants' concealment of the fact that Risperdal's adverse effects and safety or tolerability issues worsen when Risperdal is formulated using Medisorb technology and used as intended; (f) defendants concealed that due to the combined effect of the financial agreements reached with its joint venture partner, Janssen, Risperdal Consta would not be profitable unless it achieved the high end of sales projections, an unlikely outcome because of the worsening of Risperdal's adverse effects and safety or tolerability issues when the drug is formulated using Medisorb technology and used as intended; (g) the serious safety concerns for Risperdal "oral" and Risperdal Consta "depot" products, such as cerebrovascular effects in elderly patients, extrapyramidal symptoms, QT interval prolongation and diabetes, which were detected in clinical trials that went unreported to worldwide regulatory authorities for long periods, in some cases for studies completed well before the beginning of the Class Period, were negatively impacting the regulatory review process; (h) for one or more reasons related to the known but unmet manufacturing, safety or efficacy requirements for the drug, the NDA for Risperdal Consta would not be approved on July 1, 2002; and (i) the failure to disclose the defective nature of the Risperdal Consta chemical and manufacturing controls, clinical program, safety and other issues preventing the Company from realizing product approval would prevent investors from learning the extent of the misrepresentations made to them during the Class Period.
On July 1, 2002, defendants announced the receipt of a non-approvable letter for Risperdal Consta. As a result of this announcement, Alkermes' stock price dropped precipitously over the next two days to a low of $4.04, or a loss of 93% from its Class Period high of $98 per share, on total volume of 29 million shares.
If you purchased Alkermes' common stock during the Class Period, you may, no later than December 29, 2003, move to be appointed as a lead plaintiff in this class action. 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. You may retain Wechsler Harwood or other counsel of your choice to serve as your counsel in this action.
Wechsler Harwood has taken a leading role in many important actions on behalf of defrauded shareholders and has recovered hundreds of millions of dollars in those efforts. The Wechsler Harwood website (www.whesq.com) has more information about the firm and detailed information regarding this matter. If you wish to discuss this action with us, or have any questions concerning this notice or your rights and interests with regard to the case, please contact the following:
Wechsler Harwood LLP 488 Madison Avenue, 8th Floor New York, New York 10022 Toll Free Telephone: (877) 935-7400
Craig Lowther, Wechsler Harwood Shareholder Relations Department: clowther@whesq.com (Ext. 257)
For information on this and other class action lawsuits visit the Class Action Newsline at www.primezone.com/ca