Approval for Commercial Sale of Ampligen to Treat Severe Cases of ME/CFS in the Argentine Republic

At long last, Ampligen is approved somewhere. Not here, unfortunately, but it's a first step. With Argentinian approval, there is the possibility of approval elsewhere. 

More to the point, in Argentina at least, there is official acknowledgement that ME/CFS is not a psychological illness.

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Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union

PHILADELPHIA, Aug. 26, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it has received approval of its New Drug Application (NDA) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The product will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world. We also believe that there are no other products in the pipeline for approval, worldwide, for this debilitating disease. A copy of the official approval from ANMAT, translated in English, is available on the Company’s website at http://ir.hemispherx.net/Events_Presentations.

The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer. Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina. “Working closely with our partner in this effort, GP Pharm, our team at Hemispherx addressed all medical and scientific issues presented by ANMAT and deserves great credit for this major success. At Hemispherx, we may be small by big pharma standards, but our commitment to addressing this dire unmet medical need makes us mighty,” stated Hemispherx CEO Tom Equels.

Approval for commercial sale in Argentina provides a platform for potential commercial sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. Hemispherx and GP Pharm are now working to expand the approval of rintatolimod to additional countries with a focus on Latin America. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, adds further validation for the product as the Early Access Program (EAP) is launched in Europe.

“In Argentina, rintatolimod (Ampligen) has just been commercially approved for the severe disabling form of ME/CFS. The number of patients with ME/CFS is estimated to be over three million worldwide, however, only a portion of these have the severe and disabling form of the disease which we are targeting with this drug,” stated Tom Equels. “Until now, there has been no commercially available effective treatment and there are no advanced clinical candidates, other than rintatolimod, that we are aware of. This commercial approval in Argentina will dramatically improve our ability to treat patients suffering from severe ME/CFS in Latin America. We continue to work aggressively to clarify a path toward approval for those with severe ME/CFS in the United States, where we have Orphan Drug status, and therefore seven years of product exclusivity upon approval. We are greatly encouraged by this new regulatory approval in Argentina. This is the most significant accomplishment to date in Hemispherx’s plan to bring our drug to severe sufferers of ME/CFS worldwide.”

“We have worked diligently with Hemispherx to get to this point, and are now preparing for the commercial launch of rintatolimod for ME/CFS in Argentina,” commented Jorge Braver, chief executive officer of GP Pharm Latin America. “Looking ahead, we will continue to seek approval in additional Latin American countries.”

Help Irish Patients with ME - A Petition to Allow Ampligen in Ireland

This petition was started by Noreen Murphy, an Irish ME patient. Currently, Ampligen is unavailable in Ireland.

As the oldest immune-modulating drug for ME, Ampligen has a long track record, and has benefited thousands of patients. 

While it is available in much of Europe and America it is not available in Ireland.

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You can sign Noreen's petition HERE:

Make the drug Ampligen available for M.E. patients in Ireland


Petition:

There are thousands of people with M.E. (Myalgic Encephalomyelitis) in Ireland. At the very best, we receive only symptom management from our doctors, that's the best they can do for us. There is a drug, Ampligen (Rintatolimod), for the treatment of M.E.

Ampligen has been successfully trialled in the U.S.A. for the last two decades. Many M.E. patients have gone into FULL REMISSION with this drug.

We are asking the Minister For Health to make Ampligen available to us.

M.E. is an neurological illness as defined by the WHO (World Health Organisation). It affects all systems: neurological, immune, endocrine, gastrointestinal, musculoskeletal, etc. The symptoms can vary from mild, moderate, severe to very severe. It can be remitting/relapsing or progressive. Some people spend their days in a darkened room, unable to tolerate light or sound. Some are tube-fed. Others are mildly affected.

My name is Noreen Murphy. I have M.E. for over 29 years. Initially, I was very severe, then moderate for a number of years but have Severe M.E. for past few years.

HIGHLIGHTS

February 28

Ampligen should be available for those sickened by myalgic encephalomyelitis. It is a reasonable treatment option to try and a way to return some to normal life again.

February 23

Any drug that's deemed safe should be made available to people with this illness. The pain and suffering never stops, I know this as I care for my daughter who's been ill for 28 years since the age of nine.

February 18

Please make this drug available to MS sufferers. They deserve a better quality of life.

February 16

Petition has reached 500 signatures!

February 11

I have been on Ampligen on a cost-recovery, compassionate-care basis since 1999 (except for four years when I lost it); It made my immune biomarkers disappear and my viruses go dormant.. FDA has said in writing that there are no major toxicities. There are no other drugs specifically targeted to ME... show more

February 11

Petition has reached 100 signatures!

February 10

We are now live!

Ampligen to Be Supplied Throughout Europe As Well As Turkey

Hemispherx Biopharma's agreement to supply Ampligen to ME/CFS patients in Europe could not have come at a better time.

A  recent paper by a group of downstate New York psychiatrists made headlines when it proposed that fibromyalgia and CFS (among others) should be placed on the spectrum of anxiety disorders.

The agreement to use an immune modifier to treat ME/CFS underscores the position stated in the IOM report that this is not a psychogenic disease, much less an anxiety disorder.

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Hemispherx Enters Into an Agreement With myTomorrows for an Early Access Program for Rintatolimod in Europe

Press Release: PHILADELPHIA, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or "Hemispherx"), reported today that it has executed an agreement with Impatients, N.V., a Netherlands based company doing business as myTomorrows, for the commencement and management of an Early Access Program (EAP) in all of Europe and Turkey.

myTomorrows, as Hemispherx' exclusive service provider in Europe and Turkey, will perform EAP activities in Europe and Turkey to include the supply of rintatolimod for the treatment of Chronic Fatigue Syndrome (CFS) to patients with an unmet medical need.

Govert Shouten, Ph.D, Co-Founder & CBO at myTomorrows, said "Rintatolimod for CFS fits perfectly with the raison d'être of myTomorrows. CFS affects as many people in Europe as in the US and there is no drug approved anywhere specifically for CFS. In clinical trials rintatolimod has shown promising results for certain CFS patients particularly those most severely affected.

As we do with other life-threatening and debilitating diseases such as cancer, MS, and depression, myTomorrows will set up and roll out the early access programs needed to help these patients.

Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said "We are very pleased to be collaborating with myTomorrows to provide rintatolimod under these unique Early Access Programs. Not only will this collaboration create the possibility for physicians to use rintatolimod under certain circumstances, myTomorrows will collaborate with these physicians to capture data on patients treated and such data may add to our other efforts to gain full regulatory approval in Europe, Latin America, Australia, New Zealand as well as the U.S. and elsewhere."

myTomorrows was founded by physicians and experts from the pharmaceutical industry who want to facilitate early access to developmental drugs for patients with high unmet needs. Ronald Brus, M.D., was the former CEO of Crucell, a vaccine company acquired by Johnson & Johnson for $2.4 billion in 2011. Govert Shouten was previously Vice President, Business Development at Crucell.

About Rintatolimod

Rintatolimod is a member of a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.

About myTomorrows

myTomorrows provides patients that are excluded from clinical trials access to drugs in development. They focus on disease areas with unmet needs; oncology, neurology, psychiatry and rare diseases. myTomorrows identifies the latest developments in drugs and facilitates requests for access to these drugs in development. Their physicians and bio-medical specialists identify the latest drug developments from across the globe. Physicians and pharmacists can register online and request information about the drugs myTomorrows provides access to. In most countries health authorities must grant permission for treatment with a non-registered drug. myTomorrows facilitates requests for permission for physicians and pharmacists.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders especially life-threatening viruses. Hemispherx's flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod and alpha interferon LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers.

Disclosure Notice

The information in this press release is intended solely for the United States and includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of rintatolimod for the treatment of Chronic Fatigue Syndrome in the United States and abroad. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the rintatolimod in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of rintatolimod in the United States and other countries including Australia and New Zealand.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations. No evidence has suggested that rintatolimod will ever be commercially approved for the new potential treatment indications, including, but not limited, to the treatment of CFS.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that rintatolimod will ever be commercially approved for the CFS treatment indications mentioned in this release into USA or other countries.

Hemispherx Enters a Collaboration for the Commercialization of Ampligen for CFS in Australia and New Zealand

On the heels of its $8M manufacturing plant rehab, Hemispherx announced today that it has signed an agreement with Emerge to seek approval of Ampligen in Australia and New Zealand.

After decades of clinical trials for FDA approval in the US  - costing hundreds of millions of dollars -  Hemispherx has taken advantage of the IOM's stamp of legitimacy for a disease which up until now has been viewed by the medical community as a form of neurosis. A disease demands treatment, and in anticipation of a treatment for an illness that affects 17-24 million worldwide, Hemispherx was recently named one of 4 sizzling hot biotech stocks by the Wallstreet Observer.  

This is the perfect time to ask the FDA to stop stalling, and to approve Ampligen in the US.

Click HERE to call for a Congressional hearing on Ampligen.

__________________________________________________________

PHILADELPHIA, March 9, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Ampligen, an experimental immunotherapeutic, for Chronic Fatigue Syndrome in Australia and New Zealand and to commence distribution of Ampligen in both countries on a named-patient basis, where deemed appropriate.

Hemispherx and Emerge will collaborate on seeking regulatory approval from Australia's Therapeutic Goods Administration ("TGA") and New Zealand's Medicines and Medical Devices Safety Authority ("Medsafe").

Under an exclusive license to sell, market, and distribute Ampligen in Australia and New Zealand to treat Chronic Fatigue Syndrome, Emerge will implement regulatory-compliant programs to educate physicians about Ampligen for CFS and seek orphan drug designation and approval of Ampligen to treat CFS. Hemispherx will support these efforts and will supply Ampligen at a predetermined transfer price.

Chris Rossidis, Co-Founder and COO of Emerge, said, "This agreement with Hemispherx represents an opportunity which is exactly why Emerge was formed, to provide Australian and New Zealand patients with products that their physicians believe would be helpful. Given that there is no product approved specifically for the treatment of Chronic Fatigue Syndrome anywhere in the world, and at estimated prevalence rates of CFS in Australia and New Zealand, there could be 50,000 to 150,000 CFS patients with no dedicated treatment of this debilitating disease. We hope to be able to start providing Ampligen to the most severe of these patients during this year."

Recently, a blue-ribbon committee of the Institute of Medicine (IOM) of the National Academy of Sciences (USA) issued a comprehensive report on CFS reaffirming the seriousness of the disease and the need to accelerate research on potential treatments.

Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx, said, "We are very pleased to be collaborating with Emerge to provide Ampligen under these unique access programs and to work with them to gain formal regulatory approval. While continuing our efforts to gain approval in the US, we are seeking similar named-patient programs and approvals elsewhere."

About Ampligen®

Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.

About Emerge Health Pty Ltd
Emerge Health Pty Ltd is an innovative, specialized Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure they meet their customers' and partners' needs and priorities.

Emerge Health has a unique, highly experienced management team with a track record of success in the Australian and New Zealand pharmaceutical markets. Our goal is to develop long term valuable relationships with suppliers and customers and to build trust through working collaboratively with our partners.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders especially life-threatening viruses. Hemispherx's flagship products include Alferon® N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon® N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

Disclosure Notice

The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States and abroad. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries including Australia and New Zealand.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations. No evidence has suggested that Ampligen® will ever be commercially approved for the new potential treatment indications, including, but not limited, to the treatment of CFS.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Ampligen® will ever be commercially approved for the CFS treatment indications mentioned in this release into USA or other countries.

To the 21st Century Cures Initiative - Include Ampligen!

The following message is from Billie Moore. She has included an email address and a template letter.

I can't stress how important it is that Ampligen be approved as a treatment for ME/CFS. Not only would patients who are currently being helped by Ampligen reap the benefits - we all would. 

Approval of Ampligen would effectively undercut the current campaign to limit treatments to exercise and CBT, and it would permanently silence the proponents of "it's all in their heads." 

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The announcement below is from Fred Upton, Chairman of the Energy and Commerce Committee, U.S. Congress, and explains the urgency of this reply. Following that is the form email. You can send it or modify it as you wish. But please send something.

Congress is working on something that has promise of having a good effect on getting Ampligen approved - legislation through the 21st Century Cures initiative. If Ampligen is approved, even conditionally, other drug companies will take note; ME/CFS automatically becomes a "real disease"; physician and public respect follows. Ampligen helps people. Let's work to help many others receive it. It's not a panacea, but it's a very good start. It's the only thing out there likely to get FDA approval in the next 10 years. The email stresses, however, that these three requests for inclusion in the legislation are appropriate for many other under-valued, underfunded diseases.

Billie Moore
Patient Advocate

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More Valuable Ideas Shared on the #Path2Cures

21st Century Cures continued today with another blockbuster roundtable discussion to review the ideas that have been shared with the committee over the past several months and discuss next steps for the initiative. The President and CEO of the Biotechnology Industry Organization, Jim Greenwood, recently took to The Hill to share some of his ideas for accelerating the pace of cures and treatments, noting specifically the impact that Alzheimers has on our nation. Greenwood explains how accelerating this process will not only provide hope for patients and families but also will have an enormous economic impact.

As Energy and Commerce Committee Chairman Fred Upton (R-MI) noted at this morning’s event, 

“We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress. If you want your idea considered, please send it to cures@mail.house.gov as soon as possible. The more specific the idea, the better.”

*****************************************************************************

The following is to be sent to cures@mail.house.gov

Subject line: Please include Ampligen in the 21st Century Cures Legislation

To the Members of 21st Century Cures,

On behalf of the more than 1 million Americans suffering and dying from Myalgic Encephalomyelitis (sometimes referred to as Chronic Fatigue Syndrome but preferably as ME/CFS by government agencies and patient groups) we ask that the following be included in your 21st Century Cures Legislation.

1) The 2015 NIH budget should be commensurate with the size of the disease and/or the cost to the nation. For example, Multiple Sclerosis (MS), a disease the FDA states is similar in seriousness to Chronic Fatigue Syndrome but with only 400,000 patients - receives a $115 million per year in NIH funding - and there are already nine existing drugs for MS. People with ME/CFS have NO approved treatments yet more than 1 million people are sick (versus 400,000 for MS), and it receives only $5 million from the NIH. That is only $5.00 per patient! This is a ridiculously small amount. Yet CDC studies estimate it costs the nation $22 billion per year. Other funding levels for 2014:

~ Anthrax $72 million (who gets anthrax?)
~ Attention Deficit Disorder $50 million (not life threatening)
~ Smallpox $31 million (no one gets smallpox anymore)

2) One drug – Ampligen - has shown promising results against ME/CFS. There were significant improvements in approximately 40% of the patients on Ampligen! Many patients in the trials have been safely on this drug for years. Yet the FDA continues to drag its heels in approving it. We request that the legislation reflect that if a drug shows promise and the top experts in the disease believe the drug should be on the market, then FDA should use its existing regulatory authority to approve the drug, and in collaboration with the experts and the sponsors develop the appropriate follow-up studies and REMS program. The expert physicians that work with the patients and the drug have the expertise and knowledge needed to provide sound judgment. This will allow for a large proportion of new ME/CFS patients’ lives (and those with other similarly ignored diseases) to improve. Leaving patients without treatment is NOT in the best interests of public health; ME/CFS patients die early deaths from cancers, heart disease, suicides (because there are no drugs and no hope).

3) FDA should be required to provide the same type of flexible approach to chronic illnesses with few or no FDA-approved treatments that it does to those considered fatal (able to cause "imminent death"), to rare disorders, or to disorders that produce epidemics. ME/CFS falls between the two as do many chronic illness, yet cost families and the nation greatly. The fact that 1,000,000 people with ME/CFS have suffered for decades without a single FDA-approved drug requires the FDA recognize that a new approach with more flexibility is called for in this disease and other diseases which the FDA has failed to support. After DECADES of inaction, IT IS TIME.

Thank you for your attention.

(your signature and date)

Call for Congressional Hearing on Treatment for ME/CFS

Representatives Upton and DeGette

The following announcement comes from the FDA Treatment Team, a group of people dedicated to securing FDA approval for Ampligen. 

The team has drafted a letter requesting a congressional hearing on Ampligen. You can support their effort by sending your own letter (see template below).

The team has provided email addresses on their template letter. In addition, I recommend you send the letter to your own representatives as well via their web forms. Representatives always pay attention to letters sent by their constituents. You can find your representatives HERE simply by typing in your zip code.

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New Opportunities to Create FDA Action on ME/CFS Treatments

Currently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) have spearheaded a bipartisan initiative called "21st Century Cures" to increase the pace of medical breakthroughs. This initiative gives us fertile ground to press Congress and the FDA to provide an environment that attracts drug companies to ME/CFS research and for the FDA to give conditional approval of Ampligen. Remember, if we get one drug across the line, many more will follow.

We are asking you to help us continue to push the FDA to foster and approve treatments for ME/CFS. It is important that ME/CFS stay high on the FDA's agenda. Please cut and paste the following message and send it to the email addresses below.

~From The FDA Treatment Team
Cort Johnson, Bob Miller, Billie Moore, Pat LaRosa, Dr. Janet Smith, Anita Patton, and Lori Chapo-Kroger

...................................

Email to:

margaret.hamburg@fda.hhs.gov; janet.woodcock@fda.hhs.gov; janet.maynard@fda.hhs.gov; howard.koh@hhs.gov

Cc:

mark.ratner@mail.house.gov; monica.volante@mail.house.gov; rachel.stauffer@mail.house.gov; robb.walton@mail.house.gov; catie.fulton@mail.house.gov; christopher.stewart@mail.house.gov; kathryn.allen@mail.house.gov; mitchell.vakerics@mail.house.gov; heidi.ross@mail.house.gov

Subject line:
FDA fails to approve drug for ME/CFS - Time for a congressional hearing

In the body of the email:

Recently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) spearheaded a bipartisan initiative called "21st Century Cures" to increase the pace of medical breakthroughs. This initiative provides opportunities to help speed approval for treatments that affect underserved populations - such as those who are severely ill with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome).

To date, the FDA has failed to approve a drug considered safe for ME/CFS, leaving chronically ill patients to take untested, off-label medications. ME/CFS costs the United States economy approximately $20 billion annually and affects one million Americans. It has left many families in ruins.

The FDA says it will approve drugs with serious adverse side effects that they believe are effective for ME/CFS, but they won't approve Ampligen, a drug that they acknowledge is safe.

Where is the data on efficacy and safety of the drugs currently being used off-label to treat ME/CFS?

ME/CFS Expert Dr. Charles Lapp, who has treated thousands of ME/CFS patients and has used Ampligen for more than 25 years, said, "Even if Ampligen doesn't improve a patient, it does no harm."

The experts have said it works, and the FDA Advisory Committee has said it's clear that patients are experiencing benefit. More than 700 patients provided testimony at the FDA Advisory Meeting in December 2012 requesting approval of Ampligen, and more than 4,000 signed a petition after FDA denied the approval in February 2013.

In April of 2013 - four months after the FDA denied approval for Ampligen - the FDA admitted they did not have a complete understanding of ME/CFS. We believe that if the FDA had understood the unique needs of ME/CFS patients prior to the Ampligen approval hearing, the drug would have received conditional approval, leading to a functional improvement in many severely ill patients.

The FDA is to be commended for acknowledging the seriousness of ME/CFS. However, more needs to be done. The FDA needs to recognize the special circumstances and desperation of the ME/CFS community and act accordingly by assisting drug companies in bringing their products to market.

A group of patient advocates has demanded a congressional hearing, and I agree. A congressional hearing is warranted. The FDA must live up to its commitment and help those with chronic illnesses. We have a right to treatment; our voices and our experts need to be heard.

[your name]

[your city and state]

[years you have been sick]

Hemispherx Seeks Approval for Ampligen in Latin America

Hemispherx Biopharma Announces Plans to File for Regulatory Approval of Ampligen(R) to Treat Chronic Fatigue Syndrome (CFS) in Three Additional Latin America Countries

New Trademarks Now Approved

March 10, 2014 11:00 | Source: Hemispherx Biopharma, Inc.

PHILADELPHIA, March 10, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it and its partner in Latin America, GP Pharm, are planning on making applications in Chile, Peru and Uruguay for regulatory approval of Ampligen® to treat CFS.

Jorge Braver, President of GP Pharm, said, "In Latin American countries, in order to file for regulatory approval of a product, companies must first gain clearance of the trademarks in each country. We have now received  notification of clearance of the trademark "Rintamod" (Ampligen® in the US) in these three countries and are now planning on making the filings for regulatory approval."

Thomas K. Equels, Executive Vice Chairman of Hemispherx, said, "This is our next step in Hemispherx's  global strategy for Ampligen® following our July 18, 2012 announcement regarding a filing for regulatory approval of Ampligen® ('Rintamod') to treat CFS in Argentina."

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The Company's Alferon N approval in Argentina includes the use of Alferon N Injection (under the brand name "Naturaferon") for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

About GP Pharm

GP Pharm SA headquarters are located in Barcelona, Spain with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research; development and marketing of its injectable products made by others and by GP Pharm SA based on its proprietary drug delivery systems including microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of its own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.

Forward-Looking Statements

The foregoing release contains forward-looking statements that can be identified by words such as "will be, investigative, interim" or similar terms, or by express or implied discussions regarding potential efficacy for Hemispherx's Ampligen®, or regarding potential future revenues from Ampligen®.  You should not place undue reliance on these statements.  Such forward-looking statements are based on the current beliefs and expectations of Management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ampligen® will receive regulatory approval or be commercially successful in the future.  In particular, management's expectations regarding Ampligen® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K on file with the U.S. Securities and Exchange Commission.  Hemispherx is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain regulatory approval of Ampligen® for the treatment of Chronic Fatigue Syndrome. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for regulatory approval of Ampligen®. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) that the application may not be accepted by the appropriate regulatory agencies or such acceptance may be delayed and (ii) regulatory may ask for additional data, information or studies to be completed or provided prior to approval. Any failure to satisfy the regulatory agencies requirements could significantly delay, or preclude outright, approval of the Ampligen® in the Latin American Countries that we are submitting these applications.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations.

Company/Investor Contact:
Charles Jones
CJones & Associates Public Relations
888-557-6480

The FDA's Response Letter Re: Ampligen

Below is the FDA's response to my email encouraging the FDA to approve Ampligen. Their response is a PR masterpiece. If the FDA, NIH, and CDC spent as much money on researching ME/CFS as they do on their Public Relations efforts, we would have a cure by now. 

Dear Erica Verrillo,

Thank you for sharing your personal testimony as well as your desire for the U.S. Food and Drug Administration (FDA) to approve Ampligen. Please accept this response on behalf of FDA’s leadership, who forwarded your email to the Division of Drug Information for direct reply.

As evidenced by the hundreds of letters, emails, and testimonies submitted to FDA, Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) is a devastating disease with a serious impact on quality of life. We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community’s strong desire to see rintatolimod injection (Ampligen) approved.

For many years FDA has worked with Hemispherx Biopharma, Inc. (Hemispherx) on an approval pathway for Ampligen. Since the time of the original New Drug Application (NDA) submitted by Hemispherx for the use of Ampligen to treat CFS in 2007, FDA’s review division has provided many specific recommendations on how best to address deficiencies in the application. In 2009, the review division asked Hemispherx to conduct at least one additional controlled clinical study showing a convincing effect in the CFS population. No new trials were conducted. Hemispherx conducted additional analyses of their existing data, which FDA agreed to review in a resubmitted NDA.

A public meeting of FDA’s Arthritis Advisory Committee (AC) on December 20, 2012, was held to provide FDA with independent scientific and clinical expertise regarding the Ampligen NDA. At the meeting, both Hemispherx and FDA reviewers presented assessments and analyses of the NDA data to the experts, including physicians with expertise in CFS, a CFS patient representative, and an industry representative. The majority of AC members were concerned about the lack of consistency within the clinical trial results, as well as the limited size of the database available to evaluate Ampligen. The members shared FDA’s concerns, as well, about how the studies had been conducted, including multiple discrepancies and gaps in the safety data. At the end of a full day of discussion AC members voted 8-5 against the approval of Ampligen for the treatment of patients with CFS because of insufficient safety and efficacy data.

On Monday, February 4, 2013, Hemispherx announced the receipt of a Complete Response (CR) letter from the FDA for Ampligen. FDA issues a CR letter to convey that our review of an application is complete and we cannot approve the application in its present form. A CR letter describes all of the specific deficiencies that the Agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission. FDA’s decision regarding Ampligen encompassed many factors, including the safety and efficacy data and the advice of the AC. We understand the frustration and pain of ME/CFS patients and their caregivers, and how important it is that we continue to work toward development of treatments.

We want to emphasize that the CR letter issued for Ampligen is entirely separate and distinct from FDA’s support of drug development pathways for CFS – these initiatives remain unaffected and fully supported. ME/CFS is a serious disease and treatments for it represent an important area of unmet need. We will continue to encourage the pharmaceutical industry to develop new treatments in this area. To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.

We express our gratitude to you and the ME/CFS community for your unwavering support of the research and care of those with ME/CFS. We join you in this commitment, and we look forward to exploring how best to facilitate and expedite the development of safe and effective drug therapies for the signs and symptoms of this debilitating disease.

Best regards,

Mary Kremzner, PharmD
Director, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at http://twitter.com/FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

DOWN FOR THE COUNT

You can stop hitting me now...

What follows is the full text of Hemispherx Biopharma's press release. Anyone who has been following the long, long history of Ampligen vs. The World, won't be surprised that, yet again, HB has been trounced. To be fair, the odds were slightly tilted in favor of the FDA and the multi-billion dollar industry it represents. (FYI: I have italicized the touching section in which HB expresses "concern" for our health. Apparently, Bob Miller got their attention. Good job, Bob! Next time, I'll join you.)

PHILADELPHIA, Feb 04, 2013 (GLOBE NEWSWIRE via COMTEX) -- Hemispherx Biopharma, Inc. (nyse mkt:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

In its Complete Response Letter ("CRL"), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data.

In the two pivotal clinical studies that form the basis of approval for Ampligen, Hemispherx believes that the primary efficacy endpoints were met and that they showed a statistically significant improvement (i.e., with a p-value of 0.05 or less). The FDA and Hemispherx do agree that in clinical study AMP-502, the primary endpoint was met (p=0.02). In clinical study AMP-516, the FDA's analysis resulted in a p-value of 0.10, while Hemispherx's calculation resulted in a p-value of <0.05, and yet both analyses indicate that those patients on Ampligen improved over those on placebo. With regard to safety, Hemispherx has provided data from the 845 subjects who have received Ampligen, including 589 subjects suffering from severe CFS and over 200 CFS patients who have received Ampligen for at least one year or longer. The Company believes that these data are sufficient to determine the safety profile of Ampligen. At the December 20, 2012 FDA Advisory Committee meeting, 8 of the 13 Advisory Committee members voted yes on the question of "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?"

Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research regarding the Agency's decision. The purpose of the conference is to review all of the issues raised in the Agency's CRL as well as to discuss the corroborating data and experiences of clinicians and patients who have seen the benefits of Ampligen therapy.

Hemispherx has become aware that a prominent CFS advocate and long-time CFS sufferer, who has been on Ampligen since 1999 through a treatment IND, began a hunger strike on January 30, 2013 to seek FDA approval of Ampligen. Hemispherx understands the frustration that there is still no FDA-approved treatment for CFS and the concern that patients may lose access to Ampligen therapy. Out of concern for the health of the CFS community, Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, CFS clinicians and patient advocates to find a solution to this significant unmet medical need.

In the past, the FDA has shown great willingness to work with stakeholders to find solutions for serious and life-threatening illnesses. Dr. Margaret Hamburg, Commissioner of the FDA has previously stated that, "FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges." Hemispherx hopes that the FDA will view the Ampligen end-of-review conference as an opportunity to involve patient advocacy, clinicians and researchers in a concentrated effort to do something for these patients over the near-term, including further evaluation of how new legislation, such as the recently enacted "FDASIA" statute, may have a role in finding a solution. The views of one internationally recognized researcher/clinician, Dr. Nancy Klimas, who has over 20 years' experience evaluating and treating CFS patients, can be found at http://www.sciencedaily.com/releases/2013/01/130124183448.htm

DISCLOSURE NOTICE: The information in this press release and the article referenced therein includes certain "forward-looking" statements (explained below), including statements about the remaining steps, including the aforementioned end-of-review conference and appeals process, which the FDA may require and Hemispherx may take in further seeking FDA approval of the Ampligen NDA for the treatment of Chronic Fatigue Syndrome. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen NDA. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen NDA.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen and Alferon LDO. Because both Ampligen and Alferon LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net .

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "believes," "plans," "anticipates," and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations and represent the Company's judgment as of the date of this release. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved, including its intent to pursue the end-of-review conference and appeals process. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K and Hemispherx's beliefs that the Ampligen NDA may be covered by the new provisions of the FDASIA statute, which are subject to FDA interpretation and implementation, or that such provisions, if applicable, will be helpful with regard to obtaining FDA approval of the Ampligen NDA. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.

OUTPACED: The Empire Strikes Back

It can't be mere coincidence that the day before the FDA was scheduled to make its decision on Ampligen, the PACE group published the results of its lengthy study on treatments for CFS.

The study, published in Psychological Medicine on February 1 2013,  compared the effectiveness of four different types of treatment: 1) adding cognitive behavior therapy (CBT) to specialist medical care, 2) adding graded exercise therapy (GET) to specialist medical care, 3) adding adaptive pacing therapy to specialized medican care, and 4) specialized medical care alone. It should not have come as a surprise that the study confirmed "that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery."

The PACE study, of course, proved nothing of the kind. Even a quick perusal of the methods used to determine the cohort, the absurdity of the statistical analysis, and the complete lack of a viable definition of "recovery" should undermine any conclusions that this study purported to make.

Unfortunately, the mere existence of a study with even a whiff of bogus science (and institutional backing) is enough to provide fodder for those who will do anything, say anything, and invent anything, to prevent CFS and ME from being considered organic illnesses. The reason for this is clear. If Ampligen is approved, then all arguments about whether CFS and ME are psychological or physical will cease.


As far as insurance companies are concerned, that is a terrifying prospect. This is a complex illness, perhaps the most complex the world has ever seen. The costs of actually treating CFS and ME, as opposed to having its victims take a daily stroll, or chat with a counselor about their misguided "illness beliefs," would be staggering. There can be no doubt that the possibility of bankrupting insurance companies is what is foremost in the minds of the FDA committee as they weigh the "safety" of Ampligen.


Standing up against the machinery of what we call our "health care" system is what Bob Miller is currently attempting. I only hope that the tanks don't roll over him ... and all the rest of us as well.

CFS patient starts hunger strike for FDA approval of Ampligen

Bob Miller

Bob Miller on Hunger Strike: Send This 1-Minute Email to Get FDA Approval for Ampligen

February 1, 2013, Phoenix Rising

by Sasha

http://phoenixrising.me/archives/15415

Bob Miller has started a hunger strike to push for FDA approval of Ampligen. He and his wife, Courtney Alexander, who are well-known for drawing President Obama’s attention to the plight of people with ME/CFS, urge us not to do the same.

Instead, they’d like us to send the email below, alerting key decision-makers to his strike, to add pressure to approve Ampligen as a therapy for ME/CFS.

The FDA is expected to announced its decision sometime around  2^nd February – this Saturday – so there’s no time to lose.

Wherever you are in the world, please use Bob’s template to email, and do it right now. It takes less than a minute: I’ve already sent mine.

Bob’s message

Yesterday January 29th, I began a hunger strike seeking FDA approval of Ampligen, the only medication in FDA-approved clinical trials for Chronic Fatigue Syndrome, (ME/CFS).

The FDA Advisory Committee voted Ampligen is safe given the serious nature of CFS and the critical unmet need of patients.

Please support access to Ampligen for ALL ME/CFS PATIENTS by sending a note like the one below to the Secretary of Health Kathleen Sebelius, Assistant Secretary of Health Dr Howard Koh, FDA Commissioner Dr Margaret Hamburg, and FDA CDER Director Dr Janet Woodcock and Deputy Director Dr Sandra Kweder.

You can just copy and paste the email below.

Please also email or call your Congressional Representatives and Senators (look them up here and just click on your state) and ask them to investigate why the FDA refuses to approve the ONLY medication for CFS despite safe testing for 20 years. This is a health crisis!

The email

To: kathleen.sebelius@hhs.gov, margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov,

sandra.kweder@fda.hhs.gov, howard.koh@hhs.gov, ash@hhs.gov,

bobmiller42@gmail.com

Subject: CFS patient starts hunger strike for FDA approval of Ampligen

“Long-time ME/CFS patient Robert Miller from Reno, Nevada began a hunger strike in advance of the FDA’s Feb. 2nd deadline to decide on Ampligen, the ONLY medication in clinical trials for my illness. I support Mr. Miller because my life has been stolen by ME/CFS and I need real treatment options. We have waited 20 years, and we can’t wait any longer. The FDA Advisory Committee voted Ampligen is safe enough to market because CFS is so serious and there are NO medications to treat patients. Please don’t let the FDA reject the only medication CFS patients can hope for any time soon.”

Your Full Name Here:
Address Here:
Years ill:

FDA Recommends Against Drug to Treat Chronic Fatigue Syndrome

December 24, 2012 (HealthDay News) A U.S. Food and Drug Administration advisory committee on Thursday recommended against approval of the first proposed drug to treat chronic fatigue syndrome (CFS), intravenous Ampligen (rintatolimid).

Noting that the FDA denied approval for Ampligen in November 2009 due to methodological concerns, an advisory panel of the FDA reviewed a new analysis of one of the trials submitted in 2009. In Thursday's 8-to-5 vote, the advisory panel said the company hadn't provided enough data to support the approval of Ampligen. Although the FDA isn't bound to follow the recommendations of its advisory committees, it usually does so.

Ampligen, an immunomodulatory double stranded RNA drug developed by Hemispherx Biopharma in Philadelphia, PA, has been shown to help a subset of patients with CFS by reducing symptoms. The drug needs to be infused twice a week and is expensive, with a manufacturing cost of about $1,000 per patient per month. Largely positive anecdotal reports were presented in a teleconference conducted by the FDA with individuals with CFS who had used the drug.

"Patients with severely debilitating CFS suffer for years, both physically and cognitively, with little to no quality of life," write the authors of the Arthritis Advisory Committee Meeting briefing document. "The impact is felt by their families and our nation as a medical/social consequence. The current standard of care is palliative and provides little to no permanent relief."

More information: http://www.empr.com/fda-recommends-against-drug-to-treat-chronic-fatigue-syndrome/article/273785/#