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New Hemispherx Prez Says Getting Ampligen Approval Top Priority

It seems like Hemispherx Biopharma – the maker of Ampligen – has been the under the gun for years.  Last year it settled a 2012 class action lawsuit alleging it made false and misleading claims about Ampligen. It endured another lawsuit in 2009 for more alleged federal securities violations. Last year it was called “a penny-stock firm with a penchant for hype” by Damien Garde at Fierce Biotech.

decline

Hemispherx Biopharma’s financial resources have declined recently

According to Investor Wired Hemipsherx’s net loss including non-cash effects, averaged about $12 million or $(0.05) a share in the first nine months of the last two years.With regards to cash, cash equivalents and marketable securities the company lost about $4 million in the first nine months of 2015  ($16,108,000 – $12,375,000).

The news has not been all bad, though. Hemispherx Biopharma was rated the ninth best performing health care stock of 2012. Citing Hemispherx’s ability to achieve additional patent protection for Ampligen in Europe through 2029, Investor Wired put Hemispherx Biopharma on its “Biotech Stocks to Watch List” at the end of last year. It’s all more of the roller-coaster for Ampligen and Hemispherx Biopharma.

The fact that Ampligen is even still around may be something of a small miracle.  It’s hard to envision a more difficult drug pathway than for a small drug company producing a drug for a controversial disease like ME/CFS.

It’s a telling sign of drug company wariness towards ME/CFS that decades after Ampligen was introduced, it’s still the only drug to go through the FDA approval process for the disease, and no other drugs are in sight. Until FDA approves the first medicine for ME/CFS, no significant investment in this disease will likely come from the pharma industry. Ampligen represents an important logjam in ME/CFS treatment that has to be solved.

For all the difficulty surrounding Hemispherx, it should be noted that the company managed to keep Ampligen alive long enough to hopefully take advantage of the changed landscape for ME/CFS.

Change at the Top

A new era for chronic fatigue syndrome (ME/CFS)  appears to be dawning at the NIH. With Francis Collins, the head of the NIH, taking the lead in the fight to understand and treat ME/CFS, a window of opportunity has opened for Ampligen.

Equels-Thomas

Equels declared that Ampligen is Hemispherx’s number one priority

Hemispherx Biopharma’s first move to capitalize on that opportunity was to fire its long time CEO and Chairman, William Carter (and two of his relatives) and elevate Thomas Equels, former Chief Financial Officer and Executive Vice Chairman to the Presidency.

Stating that it was re-examining its fundamental priorities, Hemispherx Biopharma’s (HB’s) board pledged it would implement a “strong financial austerity plan”.  (In 2014, Carter made $2,364,874 including about $2,000,000 in cash and a $894,000 bonus.)  Equels was given a mandate to “strengthen internal controls, achieve enhanced governance, and create an environment for greater stockholder value.” Equels was brought in, in other words, to institute a new era of efficiency and productivity in order to appeal to investors.

In an interview Equels stated that “commitment, integrity and cooperation” were to be the new bylines for Hemispherx. He made it clear – in fact, he repeatedly emphasized –  that Hemispherx Biopharma’s number one goal was getting FDA approval for Ampligen for chronic fatigue syndrome (ME/CFS). To that end, Hemispherx was developing an “overarching strategy” to pull in public and private investors to move the drug forward. Acknowledging that Hemispherx’s resources were limited at this point, he said he’d be pulling the plug on all non-priority activities.

That overarching strategy includes fixing Hemispherx’s strained relationship with the FDA. There’s been no love lost between the FDA and Hemispherx Biopharma. Several advocates told me they held their breath whenever the sometimes fiery Carter spoke at the FDA hearing. Some felt Hemispherx was treated unduly harshly, and not given the opportunity to respond when safety issues the company thought were resolved came to the fore.

race for Ampligen

Can Equels finally bring Ampligen across the finish line?

The FDA, however, acknowledges that ME/CFS community urgently needs drug options, and FDA officials have said that the safety issues for the drug have been resolved. Some advocates that have met with them believe they are eager to move forward on ME/CFS.

Equels said he’d met with Janet Woodcock at the FDA to understand where the FDA sees the gaps.  He pledged Hemispherx would be there “arms locked with FDA officials” to do what was necessary to move the drug forward.  Hemispherx officials also apparently quickly talked with NINDS chief Dr. Koroshetz  not long after NIH Director Collins announced the NIH would reinvigorate ME/CFS research.

At the end of the day, Equels said, we have a proven therapy – it’s about bringing it across the finish line.

Next up: Making the Case For Ampligen

(Disclosure: Hemispherx Biopharma has contributed funding to a project underway at Health Rising.)

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16 Comments

  • Anonymous

    May 2, 2016 at 8:30 pm - Reply

    “he repeatedly emphasized – that Hemispherx Biopharma’s number one goal was getting FDA approval for Ampligen”
    HEB has looked at Ampligen for many indications.
    For what indication/illness will HEB be seeking Ampligen approval?

    • Cort Johnson

      May 2, 2016 at 8:57 pm - Reply

      That’s correct and that’s been one of the problem in my opinion. Equel’s stated HB emphasis was entirely on getting approval for Chronic fatigue syndrome. I’ll amend the blog to make that clear.

  • Alicia Butcher Ehrhardt

    May 2, 2016 at 9:24 pm - Reply

    Does it work? I haven’t seen clamoring for Ampligen that I would consider worth following – and I can’t find anything recent to read.

    Stuff from 2013 isn’t very useful.

    If it doesn’t work WELL with a significant portion of CFS patients and have few side effects, continuing to study it after all these years, ‘a drug in search of a disease,’ with or without approval, diverts money and attention from finding out what the heck is wrong with us and how to fix it.

    And gives false hopes. I’m tired of false hopes after 27 years.

    • Cort Johnson

      May 2, 2016 at 10:53 pm - Reply

      Check out the next blog coming up. Yes, Ampligen works very well in some patients and provides clinical benefits in from 30-40% of those taking it. All the doctors who’ve used Ampligen have petitioned the FDA for approval and numerous reports from patients attest to how effective it can be.

    • Patty Hirst

      May 3, 2016 at 2:38 am - Reply

      I feel the same, it’s been a long time and lots of false hopes! It’s been 30 years for me, lots of money and so many “cures” I can’t count…..Here’s hoping there is one soon!

      • Cort Johnson

        May 3, 2016 at 7:39 pm - Reply

        Agreed. I don’t know if Ampligen would work for you but if it passes the rigors of the FDA approval process, that will mean something.

    • eilidh

      May 3, 2016 at 10:09 am - Reply

      Not only does Ampligen work for a lot of patients (20 years of trial) it is absolutely vital for validation of ME/CFS that we get a drug approved for use. Psychological beliefs don’t respond to drugs and having one approved would improve our standing in the eyes of the medical world who are often sceptical about an illness with no biological treatments. It could open the gates to other drugs and more help for patients. Much more could be found out about this disease when you find out what works and what doesn’t, this is a tried and tested way of going forward.

      The approval of Ampligen would be a great day for all people with ME/CFS and I would be celebrating.

      • Cort Johnson

        May 3, 2016 at 7:37 pm - Reply

        Me too :)

  • Tina

    May 2, 2016 at 10:49 pm - Reply

    Cort, does Carter still own patent to the drug? I thought that was why the company was for years unable to fire him.

  • Cort Johnson

    May 2, 2016 at 10:58 pm - Reply

    That would be a problem (lol). According to a discussion I read on the internet Carter is reportedly suing HB for wrongful termination and asking for his full salary plus incentives. I haven’t heard anything about patents.

  • Troy

    May 3, 2016 at 8:06 am - Reply

    Has there been any studies to identify which patients are likely to benefit from Ampligen?

    • Cort Johnson

      May 3, 2016 at 7:38 pm - Reply

      Not that I know of unfortunately.

    • Heidi

      May 5, 2016 at 1:47 am - Reply

      I read recently about a study saying that patients who were able to do at least 10 minutes of activity on the 2 day CPET were more likely to benefit from Ampligen (don’t quote me on that… it might be a little different than what I wrote!). I wish I could be of more help, but I can’t recall where I read it. It was pretty recently though.

  • Tina

    May 3, 2016 at 9:49 pm - Reply

    Why can’t I have a normal disease with normal drug companies? Drama, drama. I sure hope we don’t find out they did wrongly fire Carter AND he still personally owns the patent, Jeez. Surely they thought this through. I do think we could have already had the studies FDA required for approval. I know in the beginning we didn’t have enough knowledge of the disease and drug to identify likely responders, but we’ve had that knowledge for ten years now. His patients tell me he knows. And I do understand the GDA not approving a novel drug affecting the immune system for 1 million Americans to use, including children, when it may be effective for half or fewer.

  • Lien Bess

    September 24, 2016 at 9:21 am - Reply

    Useful blog post ! I loved the analysis , Does anyone know where my assistant might find a template CA BCII 8270 version to edit ?

  • bailin

    November 24, 2016 at 9:51 am - Reply

    I am a college student from China, it’s been a year since I had CFS, but not confirmed in China. Pain, fatigue, muscle pain, dizziness, every day lymphatic swelling, gingival recession, gastrointestinal disorders, such as dozens of symptoms. We called negative HIV/AIDS in China, the disease (non – HVI) ten thousand people got this disease have been made in China. And the disease is infectious, already someone infected the whole family. It’s about the health of human beings. It is true. We is there a link between the disease and CFS, don’t know now. But there are Chinese people in the United States confirmed CFS, I, on behalf of the Chinese patients to audit Ampligen you ask for, I hope you can help us. Can eat medicine, we are really very painful. Save us.
    My name is liang hundred Lin 25 years old
    From Shanghai, China
    Thank you very much
    Address: Shanghai pudong HuaTuo Road 8 11, 280

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