Marketing History of Ampligen

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history

Ampligen®, generic 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, formerly known as Hemispherx Biopharma.[1]

Ampligen® has been available in the US by a very limited number of physicians solely as part of clinical trials.[2]

Marketing history[edit | edit source]

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).[3]
  • 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.[3]
  • 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.[3]
  • 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.[3]
  • 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.[3]
  • 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.[4]
  • 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.[5]
  • 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.[6]
  • 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.[7]
  • 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®.[8] Its main manufacturing center remains in New Brunswick, New Jersey.[9]
  • 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.[10][11]
  • 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.[12][13]
  • 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.[14]
  • 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."[2]
  • Sep 2019, AIM ImmunoTech received clearance from the U.S. Food and Drug Administration (FDA) to export Ampligen to Argentina[15]

Learn more[edit | edit source]

See also[edit | edit source]

References[edit | edit source]

  1. ↑ Hemispherx Biopharma, Inc. (December 20, 2012), Ampligen® for the Treatment of Chronic Fatigue Syndrome (PDF)
  2. ↑ 2.0 2.1 "Hemispherx Biopharma Inc. Announces Advancement in Expanded Access Program for Ampligen in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". finance.yahoo.com. Retrieved February 10, 2019.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 "Mismatched double-stranded RNA: polyI:polyC12U". Drugs in R&D. 5 (5): 297–304. 2004. ISSN 1174-5886. PMID 15357629.
  4. ↑ Verrillo, Erica (March 12, 2014). "Onward Through the Fog: Hemispherx Seeks Approval for Ampligen in Latin America". Onward Through the Fog. Retrieved August 13, 2018.
  5. ↑ Hemispherx Biopharma, Inc. (March 9, 2015). "Hemispherx Enters a Collaboration with Emerge Health for the Commercialization of Ampligen for Chronic Fatigue Syndrome (CFS) in Australia and New Zealand". GlobeNewswire News Room. Retrieved August 13, 2018.
  6. ↑ "Hemispherx Biopharma Enters Into An Agreement With MyTomorrows For An Early Access Program For Rintatolimod In Europe | BioSpace". BioSpace. August 10, 2015. Retrieved August 13, 2018.
  7. ↑ George, John (July 25, 2016). "Hemispherx ships Ampligen for European chronic fatigue syndrome program". bizjournals.com. Retrieved August 13, 2018.
  8. ↑ Hemispherx Biopharma, Inc. (July 27, 2016). "Hemispherx Biopharma Reaches Agreement with Avrio Biopharmaceuticals for the Accelerated Production of Ampligen®". GlobeNewswire News Room. Retrieved August 13, 2018.
  9. ↑ "Hemispherx Biopharma Inc". hemispherx.net. Retrieved August 13, 2018.
  10. ↑ IncHemispherx Biopharma, Inc. (August 23, 2016). "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". GlobeNewswire News Room. Retrieved August 13, 2018.
  11. ↑ "Hemispherx Biopharma, Inc. Executive Informational Overview" (PDF). Crystal Research Associates. November 27, 2016.
  12. ↑ Hemispherx Biopharma, Inc. (April 4, 2018). "Hemispherx Expands Ampligen Early Access Programme to Canada to Treat ME/CFS Patients". GlobeNewswire News Room. Retrieved August 13, 2018.
  13. ↑ Editorial, Reuters. "BRIEF-Hemispherx Expands Ampligen Early Access Programme To Canada..." U.K. Retrieved August 13, 2018.
  14. ↑ Hemispherx Biopharma, Inc. (June 15, 2018). "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". GlobeNewswire News Room. Retrieved August 13, 2018.
  15. ↑ "AIM ImmunoTech's Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome". MarketWatch. Retrieved September 26, 2019.

immunomodulator An immunomodulator is a substance that affects the functioning of the immune system

phase two A trial involve patients to assess side effects and effectiveness for a particular clinical condition. Typically 100-300 patients.

muscle strain An injury involving a stretched or torn muscle or tendon (tendons are fibrous cords of tissue that connect muscle to bone).

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