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Cohen Milstein Sellers & Toll PLLC is conducting an investigation to determine whether Hemispherx Biopharma, Inc. (“Hemispherx” or the “Company”) and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
A class action lawsuit was filed in the U.S. District Court Eastern District of Pennsylvania by another law firm on behalf of purchasers of the common stock of Hemispherx Biopharma, Inc. (NYSE: HEB) between March 19, 2012 and December 17, 2012, inclusive (the “Class Period”).
Hemispherx is a pharmaceutical company engaged in the clinical development and manufacture of new drug therapies, including Ampligen, an experimental drug to be used in the treatment of viral and immune-based chronic disorders such as Chronic Fatigue Syndrome (“CFS”). The complaint alleges that Hemispherx and certain of its officers and directors (“Defendants”) made false and misleading statements regarding the safety and efficacy of Ampligen, and also misrepresented and/or failed to disclose that Hemispherx could not demonstrate the requisite safety and efficacy of Ampligen because its clinical trials were not properly designed.
The Company submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for Ampligen in 2007. In 2009, the FDA rejected the application, stating that the clinical studies for the drug “did not provide credible evidence of efficacy of Ampligen” in patients with CFS and recommending that the Company conduct additional studies of the drug.
On October 22, 2012, the Company announced that the FDA had scheduled a meeting with an advisory committee to review the Ampligen NDA for the treatment of CFS. On December 18, 2012, the FDA posted on its website briefing documents for the December 20 advisory committee meeting that were described as “sharply critical” of the Company and Ampligen. In addition to citing “multiple concerns” with the efficacy and safety of Ampligen, the briefing documents criticized Hemispherx for submitting post-hoc analyses from a deficient Phase III study of Ampligen rather than starting a new one as requested. The briefing documents also revealed the FDA had warned Hemispherx in a meeting on June 8, 2012 that, “[i]t would be unusual for this type of data to provide adequate evidence of efficacy.”