Ampligen Update
Dr. Marc-Alexander Fluks
Date: December 7, 2007
URL: http://biz.yahoo.com/bizj/071207/1561768.html?.v=1
FDA dubs submission for Hemispherx drug incomplete
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Hemispherx Biopharma Inc. said Friday it has received a notice from the Food and
Drug Administration that the company's new drug submission for Ampligen, an
experimental treatment for chronic fatigue syndrome, was determined to be
insufficiently complete.
The Philadelphia biotechnology company said the FDA found 11 deficiencies in the
application's clinical section and three in its pre-clinical section.
Hemispherx (AMEX:HEB - News) officials said part of the problem with its filing
may be the clinical data reporting guidelines have changed since the initial
studies on Ampligen were executed in the late 1980s and early 1990s.
The company said it plans to respond promptly in writing to all of the filing
issues raised by the FDA and will request a guidance meeting to clarify any
items outstanding.
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(c) 2007 Philadelphia Business Journal
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Source: Edgar Online
Date: December 10, 2007
URL: http://biz.yahoo.com/e/071210/heb8-k.html
Termination of a Material Definitive Agreement, Financial Statements
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Item 1.02 Termination of material definitive agreement.
We notified Laboratorios Del Dr. Esteve, S.A. ("Esteve") of our intention
to terminate the license agreement that gives Esteve the right to market
Ampligen(R) for CFS in Spain, Portugal and Andorra. The basis of the
termination was non-performance by Esteve of certain contractually required
clinical trials. Negotiations were ongoing but amicable resolution could
not be reached. Esteve, as is its right under the license agreement, has
filed for arbitration seeking damages. We believe their claim is without
merit and intend to counterclaim, seeking damages.
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(c) 2007 Edgar Online
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Source: Philadelphia Business Journal
Date: December 10, 2007
URL: http://biz.yahoo.com/bizj/071210/1561828.html?.v=2
ref: See also,
http://www.me-net.combidom.com/meweb/web4.5.htm
Hemispherx shares plummet following FDA notice
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Hemispherx Biopharma Inc. shares closed down 40 percent Monday, following a
notice from the Food and Drug Administration that the company's submission
for a drug was insufficiently complete.
The Philadelphia company said Friday that the FDA found 11 deficiencies in the
application for chronic fatigue syndrome drug Ampligen's clinical section and
three in its pre-clinical section.
The company said it planned to respond promptly in writing to all of the filing
issues raised by the FDA and request a guidance meeting to clarify any items
outstanding. Hemispherx shares closed Monday at 78 cents per share.
In another Ampligen-related development, the company said Monday that it plans
to terminate a license agreement that gives Laboratorios Del Dr. Esteve of
Barcelona, Spain, the right to market Ampligen in Spain, Portugal and Andorra.
Ampligen has not been approved by regulators in those markets.
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(c) 2007 Philadelphia Business Journal