Update: On July 22, 2014, Pomerantz LLP was appointed Lead Counsel. Pomerantz LLP has filed a class action lawsuit against The Medicines Company ("Medicines" or the "Company") and certain of its officers. The class action, filed in United States District Court, District of New Jersey, and docketed under 2:33-av-00001, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired Medicines securities between February 20, 2013 and February 12, 2014 both dates inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
The Medicines Company is a global pharmaceutical company focused on providing medical solutions for critical care patients in acute and intensive care hospitals worldwide.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (1) Cangrelor, Medicines drug candidate designed to prevent blood clots during heart artery-clearing angioplasty and stenting procedures, did not show superiority to clopidogrel, a competing drug already approved by the U.S. Food and Drug Administration ("FDA"); (2) The Company's CHAMPION clinical trials which compared the efficacy of Cangrelor to clopidogrel were unethically and inappropriately administered including by delaying administration of clopidogrel and lowering its dosage; and (3) as a result of the foregoing, Medicines' public statements were materially false and misleading at all relevant times.
On February 10, 2014, the FDA released briefing documents ahead of a review by its Cardiovascular and Renal Drugs Advisory Committee ("CRDAF"), which was scheduled to review the New Drug Application ("NDA") for Cangrelor on February 12, 2014. In the briefing document, Thomas A. Marciniak, M.D., the FDA's Medical Team Leader for the review, found that Cangrelor did not show superiority to clopidogrel, and that the clinical trials sponsored by Medicines were unethically and inappropriately administered, including by delaying administration of clopidogrel and the lowering of the dosage of clopidogrel in the CHAMPION trial. According to Dr. Marciniak, "the CHAMPION trials were conducted unethically. We can refuse approval of Cangrelor based on that fact alone."
On this news, Medicines securities declined $1.80, or over 5%, on heavy volume, to close at $32.42 on February 10, 2014.
On February 12, 2014, the Company issued a press release announcing that NASDAQ has halted trading of the company's stock because an FDA advisory panel was meeting to discuss the new drug application (NDA) for Cangrelor. Later, on February 12, 2014, the FDA advisory panel voted 7-2 that Medicines' Cangrelor shouldn't be approved to prevent blood clots during heart procedures.
On this news, when trading resumed on February 13, 2014, Medicines securities declined $3.82, or over 11.5% from the previous close, on very heavy volume, to close at $29.28 on February 13, 2014.