Marketing History of Ampligen

Ampligen®, chemical name Rintatolimod, is a mismatched, double-stranded RNA molecule with immunomodulatory and antiviral properties being considered for approval for the use of ME/CFS by the Food and Drug Administration (FDA). It is manufactured by the US company, AIM ImmunoTech‎‎.

Ampligen® has been available in the US by a very limited number of physicians solely as part of clinical trials.

Marketing history
Since early in Ampligen's development, Hemispherx Biopharma 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).
 * 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.
 * 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.
 * 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 People's Republic of China.
 * 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.
 * 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.
 * 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.
 * 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.
 * 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.


 * 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®. Its main manufacturing center remains in New Brunswick, New Jersey.
 * 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 rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of patients with severe ME/CFS who have been diagnosed for over a year.
 * 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.


 * 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.
 * 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."

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 * 2004, Mismatched double-stranded RNA: polyI:polyC12U