Hemispherx Biopharma Renews Sales, Marketing, Distribution and Supply Agreement... CFS treatments

JaimeS

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Initial Target is ANMAT Approval to Treat Chronic Fatigue Syndrome Patients in Argentina

PHILADELPHIA, May 31, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma. Inc. (NYSE MKT:HEB) announced today that it executed a renewed Sales, Marketing, Distribution and Supply Agreement for Argentina with GP Pharm Latino America (GP Pharm), an affiliate company of Spanish GP Pharm SA (www.gp-pharm.com). The previous agreement had expired on June 14, 2015. Under this new agreement, GP Pharm will be responsible for gaining regulatory approval in Argentina for Ampligen®, an experimental therapeutic, to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and for commercializing Ampligen® for this indication in Argentina. The Company has granted GP Pharm expanded rights to sell this experimental therapeutic into other Latin American countries based upon GP Pharm achieving certain performance milestones. The Company has also granted GP Pharm an option to market Alferon N Injection® trademarked in Argentina as Naturaferon®, its FDA approved natural interferon, in Argentina and other Latin America countries. In 2012, under GP’s original agreement they were able to extend Alferon’s indication in Argentina to treat any disease that is refractory to Recombinant Interferon. Under this Agreement, the Company will manufacture and supply Ampligen® and Alferon® to GP Pharm.


Thomas K. Equels, Hemispherx CEO, said, “The renewal of the GP Pharm agreement is in anticipation of the upcoming ruling from ANMAT on our pending application for Ampligen’s approval to treat CFS/ME. Since Hemispherx has no operation in Argentina it needs GP Pharm as its local representative in order for ANMAT to finalize its review and potentially provide Hemispherx an approval of Ampligen to treat CFS/ME patients in Argentina. Should we obtain this approval, we expect that it will also have a dramatic beneficial effect on our early access program partnerships which we have developed in Europe and Australia”.



Jorge Braver of GP Pharm said, “Thousands of people suffer from ME/CFS, a particularly insidious disease for which there is no known cure, in Argentina and elsewhere in Latin America. We are looking forward to expanding our relationship with Hemispherx by undertaking the commercialization of Ampligen® in Latin America. We are also excited to have the opportunity to market the FDA approved product, Alferon N Injection®, a natural interferon with a proven track record of safety and historically demonstrated anti-viral capabilities, throughout Latin America.”


Link out:

https://globenewswire.com/news-rele...ution-and-Supply-Agreement-with-GP-Pharm.html
 

Sushi

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I wonder why nothing came of their earlier agreement. We were pretty interested in that a few years ago.
 
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You guys might find this interesting as it just was announced a couple days ago:

Hemispherx Announces First Shipment of Rintatolimod (Ampligen®) to Early Access Program in Europe

“This program will enable Chronic Fatigue Syndrome (CFS) patients, who face an unmet medical need in the EU, to access rintatolimod under early access regulations,”

Here is the press release: http://globenewswire.com/news-relea...ss-Program-in-Europe.html?f=22&fvtc=9&fvtv=us
 

Hip

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That is very interesting, @CaptainA.

I wonder if this European Early Access Program for pharmaceuticals provides the drugs for free as part of a clinical trial, or whether those drugs in the program need to be paid for by the patient or by his medical insurance?

Ampligen is a pretty very expensive drug, costing I believe around $40,000 per year.

And like so many other ME/CFS treatments, anecdotally Ampligen appears to have achieved a bedbound to near full remission in a very small subset of patients, but for most patients, the improvements on Ampligen were quite minor, if any (ref: 1).
 

Kati

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More news today about Hemispherx joining forces with another firm to produce Ampligen:

http://finance.yahoo.com/news/hemispherx-biopharma-reaches-agreement-avrio-123000260.html

Hemispherx Biopharma Reaches Agreement with Avrio Biopharmaceuticals for the Accelerated Production of Ampligen®




PHILADELPHIA, July 27, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the “Company") announced today that it has reached an agreement with Avrio Biopharmaceuticals (“Avrio”), Irvine California, to serve as an additional contract manufacturer of Hemispherx’s experimental drug, Ampligen®, also known by its generic name rintatolimod. Avrio, an FDA inspected facility, has the capabilities for the compounding and fill/finish of sterile clinical and commercial grade Ampligen® to satisfy the Company’s ongoing domestic clinical studies as well as the recently initiated Early Access Program (EAP) in Europe and Turkey. This agreement with Avrio should allow Hemispherx to rapidly replenish its Ampligen®/rintatolimod inventory. Serving the EAP, outside of the United States, is especially important because it has the potential to generate positive cash flow on EAP transactions while Hemispherx seeks commercial approval for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States, Argentina, and elsewhere.

Thomas Equels, Hemispherx CEO, commented, “We are pleased to be working with Avrio, a well-respected professional team that is highly motivated to support our short term goal of accelerated manufacturing of Ampligen® to serve our clinical initiatives and the EAP, as well as partner with us for the long haul. Avrio, as an additional CMO for Ampligen®, provides price efficiencies, very rapid turnarounds, and a safety net of redundancy. Maintaining a supply of clinical grade Ampligen® is one of our top priorities since many individuals with severe ME/CFS continue to seek Ampligen® availability through our access programs.”

Dr. Assad Kazeminy, CEO of Avrio Biopharmaceuticals, noted, “The new relationship with Hemispherx represents an exciting addition to our well-established client portfolio. We are delighted with the Hemispherx decision, and strongly believe that Hemispherx’s manufacturing strategy is an excellent match to Avrio’s core competencies.”


 

Riley

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Ampligen is a pretty very expensive drug, costing I believe around $40,000 per year.
I'm a current patient. The cost of the drug is 1200/month for the full dose plus around 1000/month for the cost of infusion. The infusion cost is often covered by insurance fully or partially depending on your insurance and which clinic you are at.

So if a patient is on a lower dose and has the infusion cost covered treatment could be $600/month.

On the high end, it could be $2200/month.
 

Hip

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I'm a current patient. The cost of the drug is 1200/month for the full dose plus around 1000/month for the cost of infusion. The infusion cost is often covered by insurance fully or partially depending on your insurance and which clinic you are at.
I read here that the price of Ampligen went up to $41,600 per year, not including the infusion costs.

But from what you are saying, that price does not appear to be correct.
 

Riley

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I read here that the price of Ampligen went up to $41,600 per year, not including the infusion costs.

But from what you are saying, that price does not appear to be correct.
Fortunately Hemispherx did not enact the price increase.
 

Riley

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How has your experience been?
It's saved my life. I really need to write up my story and put it it out there, but writing is still very difficult for me, and my energy is limited.

Basically, Ampligen took me from being like Whitney Dafoe up to what I'll call a 3.5/10. You may think, "3.5/10 that's not so great," but it's hard to overstate how sick I was before I started, and I was getting worse by the day.

I didn't start at 0 I started at -10.
 

Hip

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Fortunately Hemispherx did not enact the price increase.
Ah OK, so the average cost of Ampligen is still around $15,000 a year for the drug, plus around $12,000 per year for the doctor's cost of 12 monthly infusions.

Would you know why infusions are so expensive? Couldn't this be done more cheaply by a nurse in a clinic? Or does a doctor have to be present?



It's saved my life. I really need to write up my story and put it it out there, but writing is still very difficult for me, and my energy is limited.
When trying to gauge improvements to ME/CFS, I find it is useful to think in terms of the three acknowledged levels of severe of ME/CFS, which are: mild, moderate and severe. These three levels are described in this post.

Any treatment that can bring you up by one level is a major result. So for example, if you have severe ME/CFS, and a drug improves your health so that your ME/CFS becomes moderate, then that is moving up one level (from severe to moderate).

Any treatment that can bring you up two levels (eg, from severe to mild, or from moderate to cured), then that is a dramatic result.


What level would you say your ME/CFS was before starting Ampligen, and what level is it now?

How long have been taking Ampligen, by the way?
 
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Riley

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Would you know why infusions are so expensive?
Although the real dollar cost is high, infusions are actually not expensive in relative terms. Patients receive two per week, eight per month. At 1000/month that's about $125 per infusion. I haven't looked at my bill in a long time, but at least half of that cost is materials (tubing, needles, etc.). I receive a liter of saline as well so that is included in the cost. The rest of the money goes to the clinic to help cover the cost of the person doing the infusion.

By comparison hospitals can charge hundreds of dollars for a single saline infusion and thousands per infusion of a specialized drug.

Couldn't this be done more cheaply by a nurse in a clinic? Or does a doctor have to be present?
They are done by a dedicated nurse or medical assistant, and not a doctor. I think the trial protocol does require that a doctor be in the area in case of an emergency.

What level would you say your ME/CFS was before starting Ampligen, and what level is it now?
I don't think any of those descriptions really fit me. If I had to pick one, I'd say going by the "in your own words" portion I went from very severe to moderate.

How long have been taking Ampligen, by the way?
I have been on Ampligen for five years now. Unfortunately, when I stop my condition begins to worsen after about 6-8 weeks. So I am on it until there is something better available.
 

Riley

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And how long after you got the first improvement? TY
It can be a real roller coaster in the beginning. Most patients experience greatly exacerbated symptoms in the first six months. That was my experience as well. Generally speaking, towards the end of six months things began steadily trending upward for me.
 

Biarritz13

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It can be a real roller coaster in the beginning. Most patients experience greatly exacerbated symptoms in the first six months. That was my experience as well. Generally speaking, towards the end of six months things began steadily trending upward for me.
Wow...6 months is a lot of time to judge whether someone should continue or not...
 

Hip

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Although the real dollar cost is high, infusions are actually not expensive in relative terms. Patients receive two per week, eight per month. At 1000/month that's about $125 per infusion.
Ah OK, I did not realize that you need two infusions per week.



I don't think any of those descriptions really fit me. If I had to pick one, I'd say going by the "in your own words" portion I went from very severe to moderate.
The mild, moderate, severe levels are probably most easily understood in terms of what activities you are able to perform.

Those with mild ME/CFS may be working full or part time, but struggle to do so.

Those with moderate ME/CFS are generally not able to work, probably don't leave the house much, have to do domestic chores slowly with breaks and rests, and may need 1 or 2 hour's naps in the middle of day.

Those with severe ME/CFS tend to be fully housebound or bedbound, and find domestic chores like cooking or any form of housework very difficult or impossible.



I have been on Ampligen for five years now. Unfortunately, when I stop my condition begins to worsen after about 6-8 weeks. So I am on it until there is something better available.
Have you tried any other major ME/CFS treatments like Valcyte (if you have active herpes family infections), or oxymatrine (if you have active enterovirus infections)?

Or other treatments such as vitamin B12 injections, or low-dose naltrexone?
 

Hip

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By the way @Riley, are you in contact with any other ME/CFS patients who are trying or have tried Ampligen?

The reason I ask is because in the phase III clinical trial of Ampligen for ME/CFS, after 40 weeks, there was only a 5 point increase on average on the Karnofsky Scale of health (this scale goes from 0 to 100) — see Table 4 of the clinical trial study.

5 points is not that much of an improvement in ME/CFS symptoms.

ME/CFS patients in this phase III study had quite severe ME/CFS: the patients had initial Karnofsky scores ranging from 40 to 60, and the average Karnofsky score at the beginning of the study was 50. The average Karnofsky score 40 weeks later, at the end of the study, was 55. So this is not a major increase.


Of course, 5 points is just the average increase, and no doubt there were patients in the study that had much better results.

I am just trying to get some info on what percentage of ME/CFS patients Ampligen works well for, and results in major improvements (like in your case), or even results in near full remission.



Dr Daniel Peterson says that 70% of his patients respond to Ampligen (see this thread), meaning that they get at least some improvement.

But I would like to know what percentage of patients get a major improvement on Ampligen.


By a major improvement, I mean the sort of improvement I described above, ie, moving up one level from severe to moderate ME/CFS, or moving up one level from moderate to mild ME/CFS.

On the Karnofsky Scale, I would myself define a major improvement as a 20 point increase.

On the Karnofsky Scale from 0 to 100, I would say that:

Perfect health = 100
Mild ME/CFS = 80 or 90
Moderate ME/CFS = 60 or 70
Severe ME/CFS = 40 or 50
Very severe ME/CFS = 20 or 30


Here is the Karnofsky Scale for ease of reference:
100— Able to work. Normal; No complaints; No evidence of disease.

90 — Able to work. Able to carry on normal activity; Minor symptoms.
80 — Able to work. Normal activity with effort; Some symptoms.


70 — Independent; not able to work. Cares for self; Unable to carry on normal activity.
60 — Disabled; dependent. Requires occasional assistance; cares for most needs.


50 — Moderately disabled; dependent. Requires considerable assistance and frequent care.
40 — Severely disabled; dependent. Requires special care and assistance.


30 — Severely disabled. Hospitalized, death not imminent.
20 — Very sick. Active supportive treatment needed.


10 — Moribund. Fatal processes are rapidly progressing
 
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LaurelW

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I've also been on Ampligen for five years, and it took me from severe to moderate ME. I've been on one dose a week for two months, and seem to be maintaining my health. My insurance (private plus Medicare) covers the entire cost of the infusions. (I'm really, really lucky to have those).

I also wanted to mention that I keep improving the longer I'm on the drug.
 

Hip

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I've also been on Ampligen for five years, and it took me from severe to moderate ME.
How long would say it took initially to attain this improvement from severe to moderate, when you first started Ampligen? Did you have any worsening of ME/CFS symptoms in the first few months or the first year on Ampligen?



I've been on one dose a week for two months, and seem to be maintaining my health.
That's very interesting; if you continue to maintain your health on just one infusion per week, I guess it would halve the cost of Ampligen, which usually requires two infusions per week.