Monday, October 4, 2010

Hemispherx Biopharma’s Lengthy Struggle to Bring Chronic Fatigue Syndrome Drug Ampligen to Market Leaving Investors Weary, Where is HEB Heading Next?

It has been nearly a year since Hemispherx Biopharma, Inc. (NYSE AMEX: HEB) received the news that Ampligen, the Chronic Fatigue Syndrome (CFS) drug they have been working on for more than three decades, was not being approved by the FDA. While the FDA said it wanted HEB to conduct additional studies to demonstrate Ampligen’s effectiveness time may be running out for the company when it comes to investors as many have grown tired of waiting.
While HEB has long stated that Ampligen could target diseases that included Hepatitis B and Hepatitis C as well as kidney cancer and metastatic malignant melanoma what has attracted investors most has been the potential surrounding CFS. With more than four million Americans suffering from CFS it appeared HEB had the inside track on the treatment drug but the FDA has derailed those beliefs and despite CEO William Carter’s insistence that the rejection “provided us with a clear path to approval and commercialization” the stock has continued to tumble.
Last September the stock was trading at its 52-week high of $2.24 and when news from the FDA hit in November shares began to dip, eventually sinking below the $1.00 mark in December and they haven’t seen that level since. HEB actually hit its 52-week low of 0.43 in June but has since established a five day moving average of 0.52, a .0.02 improvement over its 50-day moving average but still a significant drop from its 200-day moving average of 0.64.
HEB certainly wasn’t helped by their August agreement to settle all pending securities class actions against them. Allegations leveled against the biotechnology firm asserted the company, along with certain officers, misrepresented the status of their drug application for Ampligen. Details of the settlement, which still requires court approval, have not been disclosed. While the company stated the settlement “expressly is not an admission of any culpability by Hemispherx or its officers” it hasn’t won them any favor among investors who have seen it as yet another blow to their credibility.
With the difficulties in getting Ampligen approved by the FDA the company has been touting its Alferon N Injection, an FDA approved intralesional treatment of genital warts. While there has certainly been success in gaining FDA approval for Alferon N Injection it’s the company’s declaration, published on their own site, that “Alferon N Injection may also have activity against other viral infections such as Multiple Sclerosis, Hepatitis C, HIV, West Nile Virus, and SARS.” HEB does note that Alferon N Injection has not been approved for that use but it seems like the treatment is a broad stroke for a variety of serious viruses, infections and diseases.
Skeptics of HEB have pointed to this broad stroke as one reason for their concern as it appears to be the same approach the company has taken with Ampligen as they announced in their recent quarterly report the completion of a “three-year research program funded by the National Institute of Infectious Disease of Japan indicating that a nasally delivered flu vaccine, when coupled with Ampligen®, yielded positive results in providing a more robust and longer lasting immune response in non-human primates.”
That same report also highlighted that “In connection with Max Neeman International, a leading clinical research organization in India, the Company obtained approval to begin a Phase II b study from the Indian Drugs Controller General as it works to enroll subjects for the current monsoon season to treat seriously ill hospitalized flu patients evaluating Alferon N Injection.”
So if Ampligen never receives approval as a treatment for CFS it could still find its way as a flu and influenza vaccine enhancer.
This is something that shouldn’t be overlooked as any type of treatment or treatment enhancer for an influenza outbreak or respiratory disorder could prove tremendously beneficial to a shareholder. In noting that Ampligen, as well as Alferon N Injection, have reportedly shown promise in that area and if they continue to show more promise in that arena then HEB could shift their focus to marketing them as such.
See below for a chart on Hemispherx Biopharma:
Technical Chart on HEB
Technical Chart on HEB

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