Marketing History of Ampligen

Ampligen® , chemical name Rintatolimod, is a mismatched, double-stranded RNA molecule with immunomodulatory and antiviral properties being considered for FDA approval for the use of chronic fatigue syndrome. It is manufactured by the US company, Hemispherx Biopharma.

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:

• 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 Programme (SAP) in Canada for patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
• 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 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who have been diagnosed for over a year.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 chronic fatigue syndrome.
• 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.
• 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.

Learn more

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

See also

• Ampligen

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

myalgic encephalomyelitis (M.E.) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.

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).