Cohen Milstein Sellers & Toll PLLC Continues to Investigate Hemispherx Biopharma, Inc. Following the FDA’s Rejection of the Ampligen New Drug Application
WASHINGTON--(BUSINESS WIRE)-- 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.”
TheStreet.com reported on this apparent discrepancy between the FDA’s comment and the Company’s repeated representations that the FDA had “agreed to accept” the post-hoc data analyses proposed by the Company in lieu of an additional clinical trial, asserting that: “Hemispherx Biopharma (HEB) lied to investors and to the Securities and Exchange Commission by failing to disclose serious concerns raised by the U.S. Food and Drug Administration about its chronic fatigue syndrome drug Ampligen.” The price of Hemispherx shares fell from $0.64 to $0.37 on December 18.
On Monday, February 4, 2013, Hemispherx announced the receipt of a Complete Response letter from the FDA regarding Ampligen, which conveyed that the FDA’s review of the Ampligen application was complete and that it would not approve the application in its present form.
Cohen Milstein encourages all investors who purchased Hemispherx common stock between March 19, 2012 and December 17, 2012 or former employees with information concerning this matter to contact the firm.
If you are a Hemispherx shareholder and would like to discuss your right to recover for your economic loss, you may, without any cost or obligation, call Cohen Milstein’s Managing Partner, Steven J. Toll at (888) 240-0775 or (202) 408-4600, or email him at firstname.lastname@example.org. If you wish to serve as lead plaintiff, you must move the Court no later than February 22, 2013 to request that the Court appoint you as lead plaintiff. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. To be appointed lead plaintiff, the Court must decide that your claim is typical of the claims of other class members, and that you will adequately represent the class. Your share in any recovery will not be enhanced or diminished by the decision whether or not to serve as a lead plaintiff. Any member of the proposed class may retain Cohen Milstein Sellers & Toll PLLC or other attorneys to serve as your counsel in this action, or you may do nothing and remain an absent class member.
Cohen Milstein Sellers & Toll PLLC has significant experience in prosecuting investor class actions and actions involving securities fraud. The firm has offices in Washington, D.C., New York, Chicago, Philadelphia and Palm Beach Gardens, and is active in major litigation pending in federal and state courts throughout the nation.
The firm’s reputation for excellence has repeatedly been recognized by courts which have appointed the firm to lead positions in complex multi-district or consolidated litigation. Cohen Milstein Sellers & Toll PLLC has taken a lead role in numerous important cases on behalf of defrauded investors, and has been responsible for a number of outstanding recoveries which, in the aggregate, total over a billion dollars. Prior results do not guarantee a similar outcome. For more information visit www.cohenmilstein.com.
If you have any questions about this notice or the action, or with regard to your rights, please contact either of the following:
Steven J. Toll, Esq.
Cohen Milstein Sellers & Toll PLLC
1100 New York Avenue, N.W.
West Tower, Suite 500
Washington, D.C. 20005
Telephone: (888) 240-0775 or (202) 408-4600
Email: email@example.com; firstname.lastname@example.org
KEYWORDS: United States North America District of Columbia