Hemispherx BioPharma (HEB)

[Brico]

HEB agrees to pay $2.75M settlement


Philadelphia Business Journal
June 3 2015

http://www.bizjournals.com/philadelphia/blog/health-care/2015/06/phila-biotech-hemispherx-biopharma-settlement.html?ana=yahoo


Philadelphia biotechnology firm agrees to pay $2.75M settlement
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A Philadelphia biotechnology company has tentatively agreed to pay
$2.75 million to resolve a lawsuit brought by its shareholders, who
allege the company made 'material misrepresentations and omissions'
regarding the status of a new drug application for its lead new drug
candidate. The class action lawsuit was filed against Hemispherx
Biopharma, which has spent more than three decades developing Ampligen
for a variety of possible uses. It is currently studying the drug's
potential use as a therapeutic and preventative vaccine enhancer.

In 2007, Hemispherx filed a new drug application for Ampligen seeking
to market the drug as a treatment for chronic fatigue syndrome. The
Food and Drug Administration rejected the application in 2009 saying
the clinical data submitted did not provide 'credible evidence' of the
product's effectiveness. The agency suggested Hemispherx conduct an
additional clinical study for Ampligen.

Instead Hemispherx (NYSEMKT:HEB), in 2012, submitted additional
analyses of data from a previously conducted clinical trial as part of
its response to the concerns raised by the FDA when it rejected the
Ampligen application.

In early 2013, the FDA once again rejected Hemispherx's application
for Ampligen - after an advisory panel voted not to approve the drug
in December 2012 - stating data submitted with the application did not
provide substantial evidence of Ampligen 's effectiveness in treating
patients with chronic fatigue syndrome, or sufficient information to
determine whether the drug was safe when used to treat patients with
the condition.

The lawsuit ' filed on behalf of investors who purchased or acquired
Hemispherx common stock from March 14, 2012 through and Dec. 20, 2012
' alleges Hemispherx representatives 'touted purportedly positive
results from Ampligen's clinical trials.' The lawsuit also notes the
company's stock dropped 43 percent to just under 37 cents per share
after the application was rejected a second time. The stock opened
Tuesday morning at 24 cents per share. The proposed $2.75 million
settlement still requires court approval.

A final approval hearing on the proposed settlement will take place
July 22 at U.S. District Court in Philadelphia.

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