Sorry!! The article you are trying to read is not available now.
Thank you very much;
you're only a step away from
downloading your reports.

Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review

By

Shares of the drug maker are falling after FDA staff questioned whether the drug Ampligen works. The stock previously was on a tear, running up 200% in 2012 on hope for US approval of the treatment.

PrintPRINT
MINYANVILLE ORIGINAL Shares of drug developer Hemispherx BioPharma (NYSEAMEX:HEB) are falling Tuesday after a government report questioned whether the company's treatment for chronic fatigue syndrome works. The stock fell by almost half after previously rising more than 200% this year.

Philadelphia-based Hemispherx is trying to win US approval for its drug Ampligen. In a report, government reviewers not only question whether the drug is effective, but they also point out that the company was warned earlier this year that its drug research data may not support approval.

"It would be unusual for this type of data to provide adequate evidence of efficacy. However, the adequacy of the data will ultimately be a review issue," Food and Drug Administration officials told company representatives in June. That's according to this report released today.

Hemispherx faces a panel of expert advisers to the FDA on Thursday. The advisers will hear arguments from the company on why the experimental drug Ampligen should be approved for sale in the US. The FDA will consider the advisers' recommendations as it decides whether to approve the medicine. The agency is expected to decide by February 2.

In a review of the drug posted online, staff for the FDA questioned a pair of studies of patients conducted to show Ampligen's effectiveness. "Signals of efficacy are inconsistent between the two trials," staff reviewers wrote.

Throughout the report, the descriptions for the study were more blunt. A methodology used in one trial was "ill-defined and invalid." "Limited conclusions" about safety and effectiveness can be drawn from data, FDA staffers said. (See the meeting briefing documents here.)

FDA staff reviewers raised a number of issues related to the research of the drug, including study design and execution, patient selection for the trials, and analysis of the data. What's more, the company is relying on research conducted before the FDA first rejected the drug in 2009. There are also questions about the safety of the drug, including potential liver damage. As these FDA staff reviews go, the report was scathing.

Hemispherx officials declined to comment, citing the upcoming FDA panel. "It is not appropriate for companies to speak to the press prior to an advisory committee," a spokeswoman says.

Shares of the company fell 45% to $.36 midday Tuesday. Public since 1996, the stock traded above $17 per share in early 2000. It traded as high as $1 in September.

Twitter: @brettchase

Follow the markets all day every day with a FREE 14 day trial to Buzz & Banter. Over 30 professional traders share their ideas in real-time. Learn more.
< Previous
  • 1
Next >
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.

Copyright 2011 Minyanville Media, Inc. All Rights Reserved.
PrintPRINT

Busy? Subscribe to our free newsletter!

Submit
 

WHAT'S POPULAR IN THE VILLE