The complaint filed in the action charges Dendreon and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Dendreon is a biotechnology company focused on the development and commercialization of therapies for cancer. Its most advanced product is Provenge (sipuleucel-T), an active cellular immunotherapy for advanced prostate cancer.
Specifically, the complaint alleges that the defendants made false and misleading statements regarding the progress of the Company's Biologics License Application ("BLA") for Provenge. According to the complaint, the FDA conducted a pre-approval Chemistry, Manufacturing and Controls (CMC) inspection of Dendreon's Hanover, New Jersey manufacturing facility in mid- February 2007 and issued to Dendreon what is known as an FDA Form 483, Inspectional Observations Report, which cited various violations of FDA regulations at the Dendreon facility. Pursuant to FDA regulations, the complaint alleges, the issuance of a Form 483 made it highly likely that FDA approval would be delayed substantially past May 15, 2007, the anticipated FDA review date.
According to the complaint, the defendants repeatedly failed to disclose this information to investors and made false and misleading statements, thereby artificially inflating Dendreon's stock price. The complaint further alleges that certain officers and directors traded on this information without disclosing it to the investing public. The complaint alleges that the Company only began disclosing this information as part of its May 9, 2007 announcement that the FDA had issued a Complete Response letter denying approval for Provenge, which letter cited the same CMC issues allegedly known to the defendants in February. As a result of this disclosure, Dendreon stock lost nearly 70% of its market value, causing significant losses to investors.
As summarized by the Company’s Form 10-Q, beginning on May 24, 2007, four proposed securities class action suits were filed in the United States District Court for the Western District of Washington, on behalf of purchasers of the Company’s common stock, purporting to state claims for securities law violations stemming from our disclosures related to Provenge and the FDA’s actions regarding our BLA for Provenge. The complaints seek compensatory damages, attorney’s fees and expenses. On October 4, 2007, the Court consolidated these actions under the caption McGuire v. Dendreon Corporation, et al., and designated a lead plaintiff. The lead plaintiff designated the complaint filed June 6, 2007 in McGuire, et al. v. Dendreon Corporation, et al., as the operative complaint. On December 21, 2007, the Company and individual defendants jointly filed a motion to dismiss the complaint. By order dated April 18, 2008, the Court granted the motion to dismiss the complaint, holding that plaintiffs failed to plead a claim against the Company or the individual defendants, and allowing plaintiffs thirty days to file an amended complaint. Plaintiffs filed an amended complaint on June 2, 2008, naming Dendreon, our chief executive officer, and a senior vice president as defendants. Defendants filed a motion to dismiss the amended complaint on July 2, 2008. By order dated December 5, 2008, the Court granted the motion to dismiss the allegations against our chief executive officer based on allegedly false or misleading statements and his sale of Dendreon stock, and denied the remainder of the motion. The Court gave plaintiffs permission to file an amended complaint to reassert their allegations against our chief executive officer, and plaintiffs filed a second amended complaint on January 5, 2009. Defendants filed a motion to dismiss the second amended complaint on January 29, 2009. On May 21, 2009, the Court issued an order granting in part, and denying in part, defendants’ motion to dismiss the second amended complaint, and allowing leave to amend. Plaintiffs filed a third amended complaint on June 8, 2009. On June 29, 2009, defendants filed an answer to the third amended complaint. The parties have commenced discovery, and exchanged initial disclosures on July 22, 2009. Trial in this action has been set for October 18, 2010.
On January 14, 2010, the plaintiffs filed a motion to certify the class.
On May 27, 2010, an Order on Motion For Class Certification was granted by the Court.
On September 17, 2010, a Dismissal Order was issued that this action and all claims asserted were Dismissed with prejudice and without costs to any party.
On February 17, 2012, a Final Judgment and Order of Dismissal with Prejudice was entered by the Court.
On March 9, 2012, Order Approving Payments and Distributions from Settlement Fund was entered onto the Court’s docket.