According to the law firm press release, Impax is a specialty pharmaceutical company engaged in the development, manufacture and marketing of bio-equivalent pharmaceutical products, referred to as generic products, in addition to the development of proprietary branded products. The Company operates in two segments, referred to as the "Global Pharmaceuticals Division" ("Global Division") and the "Impax Pharmaceuticals Division" ("Impax Division").
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the quality control at the Company's Taiwan production facility. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company failed to maintain proper quality control and manufacturing practices at its Taiwan facility in violation of current Good Manufacturing Practices ("cGMP"); (2) the manufacturing deficiencies at the Taiwan facility could have a material adverse impact on the Company's ability to successfully launch its new drug, RYTARY; (3) the manufacturing deficiencies at the Taiwan facility jeopardized the Company's ability to manufacture, sell, and distribute generic pharmaceutical products; and (4) based upon the above, Defendants lacked a reasonable basis for their positive statements about the Company and its outlook, including statements about its ability to launch RYTARY.
On July 29, 2014, Impax announced that the FDA completed an inspection of the Company's Taiwan facility. The FDA's inspection covered two areas. First, it covered a Pre-Approval Inspection for RYTARY, given the critical importance of the Taiwan facility to the manufacturing processes of the Company's drug candidate. Moreover, it included a general good manufacturing practices inspection. Based on its inspection, the FDA issued a Form 483 (a form used by the FDA to document and communicate deficiencies in a company's manufacturing quality-control system), stating that it had found "ten inspectional observations," or deficiencies, at the Taiwan facility.
On this news, the Company's shares fell $4.27, or over 15.23%, to close at $23.76 on July 29, 2014.
On November 19, 2014, the Court issued an Order appointing lead plaintiff and approving lead counsel. Lead plaintiff filed an amended complaint on December 10.
The parties entered into a Stipulation of Settlement on May 27, 2015. This Settlement was preliminarily approved by the Court on June 22. On December 21, the Court granted final approval of the Settlement and dismissed this case.