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Marketing History of Ampligen
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==Marketing history== Since early in Ampligen's development, [[AIM ImmunoTech]] has entered into many agreements with different distribution companies around the world while awaiting US [[FDA]] approval. The list below is a sampling: * 2000, Crystaal Corporation (now Biovail Pharmaceuticals Canada) acquired exclusive marketing rights to Ampligen in [[Canada]], where it submitted an NDA for the agent for the treatment of [[chronic fatigue syndrome]] (CFS).<ref name=":0">{{Cite journal | date = 2004 | title = Mismatched double-stranded RNA: polyI:polyC12U|url=https://www.ncbi.nlm.nih.gov/pubmed/15357629|journal=Drugs in R&D|volume=5|issue=5|pages=297–304|issn=1174-5886|pmid=15357629}}</ref> * 2001, Hemispherx Biopharma announced that it was initiating phase II/III trials of Ampligen in the treatment of late-stage, multidrug-resistant strains of HIV in the European Union.<ref name=":0" /> * 2002, Esteve and Hemispherx Biopharma entered into a collaborative agreement under which Esteve will be the sole distributor of Ampligen in [[Spain]], [[Portugal]] and [[Andorra]] for the treatment of CFS.<ref name=":0" /> * 2003, Hemispherx Biopharma Inc. entered into an agreement with Guangdong Medicine Group Corporation to organise clinical trials, marketing, sales and distribution for both of its lead compounds, Ampligen and Alferon N in the [[China|People's Republic of China]].<ref name=":0" /> * 2004, Fujisawa Deutschland GmbH, a subsidiary of Fujisawa Pharmaceutical Co., entered into an option agreement with [[Hemispherx Biopharma]] with the intent of becoming a distributor for Ampligen for the potential treatment of chronic fatigue syndrome in [[Germany]], [[Switzerland]] and [[Austria]].<ref name=":0" /> * 2009 and 2013, FDA rejected Ampligen as an ME/CFS treatment. * 2014, Hemispherx Biopharma 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. The drug has been trademarked as "Rintamod" in these three countries.<ref>{{Cite web|url=https://cfstreatment.blogspot.com/2014/03/hemispherx-seeks-approval-for-ampligen.html | title = Onward Through the Fog: Hemispherx Seeks Approval for Ampligen in Latin America | last = Verrillo|first = Erica | date = 2014-03-12 | website = Onward Through the Fog|access-date=2018-08-13}}</ref> * 2015, Hemispherx Biopharma executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Ampligen 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.<ref>{{Cite news | url=http://www.globenewswire.com/news-release/2015/03/09/713500/10123752/en/Hemispherx-Enters-a-Collaboration-with-Emerge-Health-for-the-Commercialization-of-Ampligen-for-Chronic-Fatigue-Syndrome-CFS-in-Australia-and-New-Zealand.html | title = Hemispherx Enters a Collaboration with Emerge Health for the Commercialization of Ampligen for Chronic Fatigue Syndrome (CFS) in Australia and New Zealand | last = Hemispherx Biopharma, Inc. | date = Mar 9, 2015 |work=GlobeNewswire News Room|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref> * Aug 2015, Hemispherx Biopharma 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) to bring Ampligen as an experimental drugs to all of Europe and [[Turkey]].<ref>{{Cite news | url=https://www.biospace.com/article/releases/hemispherx-biopharma-enters-into-an-agreement-with-b-mytomorrows-b-for-an-early-access-program-for-rintatolimod-in-europe-/ | title = Hemispherx Biopharma Enters Into An Agreement With MyTomorrows For An Early Access Program For Rintatolimod In Europe {{!}} BioSpace | last = | first = | date = Aug 10, 2015 |work=BioSpace|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref> * Jul 2016, Hemispherx Biopharma announced that on 25 Jul 2016 it shipped its first order of Ampligen for an Early Access Program in EU and Turkey.<ref>{{Cite web|url=https://www.bizjournals.com/philadelphia/news/2016/07/25/hemispherx-ships-ampligen-for-european-chronic.html | title = Hemispherx ships Ampligen for European chronic fatigue syndrome program | last = George | first = John | date = Jul 25, 2016 | website = bizjournals.com|archive-url=|archive-date=|access-date=2018-08-13}}</ref> * Jul 2016, Hemispherx Biopharma 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®.<ref>{{Cite news | url=https://globenewswire.com/news-release/2016/07/27/859302/0/en/Hemispherx-Biopharma-Reaches-Agreement-with-Avrio-Biopharmaceuticals-for-the-Accelerated-Production-of-Ampligen.html | title = Hemispherx Biopharma Reaches Agreement with Avrio Biopharmaceuticals for the Accelerated Production of Ampligen® | last = Hemispherx Biopharma, Inc. | date = Jul 27, 2016|work=GlobeNewswire News Room|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref> Its main manufacturing center remains in New Brunswick, New Jersey.<ref>{{Cite web|url=http://www.hemispherx.net/manufacturing&research.php | title = Hemispherx Biopharma Inc. | website = hemispherx.net|access-date=2018-08-13}}</ref> * Aug 2016, Hemispherx Biopharma 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 [[Ampligen|rintatolimod]] (U.S. tradename: Ampligen®) in the [[Argentina|Argentine Republic]] for the treatment of patients with [[Severe and very severe ME|severe ME/CFS]] who have been diagnosed for over a year.<ref>{{Cite news | url=http://www.globenewswire.com/news-release/2016/08/23/866212/0/en/Hemispherx-Biopharma-Announces-Major-Breakthrough-Approval-for-Commercial-Sale-of-Rintatolimod-U-S-Tradename-Ampligen-to-Treat-Severe-Cases-of-Myalgic-Encephalomyelitis-Chronic-Fat.html | title = Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the Argentine Republic | last = IncHemispherx Biopharma, Inc. | date = Aug 23, 2016|work=GlobeNewswire News Room|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref><ref>{{Cite news | url=http://cdn2.hubspot.net/hubfs/150154/docs/Hemispherx-Executive-Informational-Overview-11-27-16.pdf?__hssc=75734090.1.1482434979170&__hstc=75734090.d484bcfed76166643c7e8f36a0c76637.1482434979170.1482434979170.1482434979170.1&__hsfp=4187238277&hsCtaTracking=afde00a7-b0f3-44d3-b072-5febf480affb%7Cb8ddd437-9009-4bb9-a8fe-65a376fff33f | title = Hemispherx Biopharma, Inc. Executive Informational Overview | last = | first = | date = Nov 27, 2016|work=Crystal Research Associates|access-date=|archive-url=|archive-date=|format=PDF}}</ref> * Apr 2018, Hemispherx Biopharma, Inc. (NYSE American:HEB), announced today it amended its agreement with [[Netherlands]]-based myTomorrows to include management of a Special Access Program (SAP) in [[Canada]] for patients suffering from ME/CFS.<ref>{{Cite news | url=https://globenewswire.com/news-release/2018/04/04/1459981/0/en/Hemispherx-Expands-Ampligen-Early-Access-Programme-to-Canada-to-Treat-ME-CFS-Patients.html | title = Hemispherx Expands Ampligen Early Access Programme to Canada to Treat ME/CFS Patients | last = Hemispherx Biopharma, Inc. | date = Apr 4, 2018|work=GlobeNewswire News Room|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref><ref>{{Cite news | url=https://uk.reuters.com/article/brief-hemispherx-expands-ampligen-early/brief-hemispherx-expands-ampligen-early-access-programme-to-canada-to-treat-me-cfs-patients-idUKFWN1RH0GQ | title = BRIEF-Hemispherx Expands Ampligen Early Access Programme To Canada... | last=Editorial|first = Reuters|work=U.K.|access-date=2018-08-13|language=en-GB}}</ref> * Jun 2018, Hemispherx Biopharma, Inc. announced First 8,500 Vial Lot of Ampligen to Supply Expanded Access Programs in the [[United States]], Europe and [[Canada]] for ME/CFS and Pancreatic Cancer and Announces Successful Finish of Second Commercial Size Lot.<ref>{{Cite news | url=https://globenewswire.com/news-release/2018/06/15/1525296/0/en/Hemispherx-Releases-First-8-500-Vial-Lot-of-Ampligen-to-Supply-Expanded-Access-Programs-in-the-United-States-Europe-and-Canada-for-ME-CFS-and-Pancreatic-Cancer-and-Announces-Succes.html | title = Hemispherx Releases First 8,500 Vial Lot of Ampligen to Supply Expanded Access Programs in the United States, Europe and Canada for ME/CFS and Pancreatic Cancer and Announces Successful Finish of Second Commercial Size Lot | last = Hemispherx Biopharma, Inc. | date = Jun 15, 2018|work=GlobeNewswire News Room|access-date=2018-08-13|archive-url=|archive-date=|language=en-US}}</ref> * Jan 2019, Hemispherx Biopharma Inc. Announces Advancement in Expanded Access Program for Ampligen in the Treatment of ME/CFS. AMP511 is the Expanded Access Program (EAP) the FDA has approved which "will allow treatment of up to 100 ME/CFS patients at any one time at approved clinical infusion therapy sites."<ref name=":1">{{Cite web|url=https://finance.yahoo.com/news/hemispherx-biopharma-inc-announces-advancement-133000883.html | title = Hemispherx Biopharma Inc. Announces Advancement in Expanded Access Program for Ampligen in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome|website=finance.yahoo.com|language=en-US|access-date=2019-02-10}}</ref> * Sep 2019, AIM ImmunoTech received clearance from the U.S. Food and Drug Administration (FDA) to export Ampligen to Argentina<ref>{{Cite web|url=https://www.marketwatch.com/press-release/aim-immunotechs-ampligen-receives-clearance-from-fda-for-exportation-to-argentina-for-the-treatment-of-severe-chronic-fatigue-syndrome-2019-09-24 | title = AIM ImmunoTech's Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome|website=MarketWatch|language=en-US|access-date=2019-09-26}}</ref>
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