The manufacturing contract – financial terms of which were not disclosed – will see Avrio Biopharmaceuticals make Ampligen (rintatolimod) – a double stranded RNA-based therapy - at its facility in Irvine, California.
According to Hemispherx hiring Avrio as supplier will allow it to generate revenue from Ampligen early access programmes in Europe while it continues to try and win approval from the US Food and Drug Administration (FDA).
US approval efforts
Ampligen has been available as a treatment for CFS in Canada since 1997 under the country’s special access programme. The scheme allows physicians to prescribe unapproved medicines to seriusly ill patients when no other treatments are available.
Similarly, the European Medicines Agency (EMA) granted the drug orphan status for the treatment of Ebola virus infection last April. At the time the London-based agency cited the lack of satisfactory treatments as the basis for its decision.
The US FDA also granted Ampligen orphan drug designation for CFS in 1998. However, unlike either the EMA or Health Canada, the US regulator has said it will not approve the product.
In a complete response letter sent to Hemispherx in 2013, the agency raised questions about safety and efficacy. It also said the firm needed “conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.”
In its most recent quarterly filing in May, Hemispherx said it plans to keep seeking approval for Ampligen in the US.
According to Hemispherx Ampligen has the ability to prevent viral infections from supressing the innate immune response.
The firm also claims it can treat chronic fatigue syndrome by interacting with an enzyme called RNase L that is associated with the condition.
Avrio is one of a number of contract manufacturing organisations that has worked with Ampligen.
Hemispherx originally asked with Spokane, Washington-based contractor HollisterStier - now Jubilant HollisterStier Laboratories – to make the drug on its behalf in 2006.
In 2014, the firm said it had agreed to buy clinical batches of the drug from the contractor for $700,000.
A Hemispherx spokseman told us the firm "intends to use both as CMOs for the fill and finish of Ampligen."
Also in 2014, Hemispherx asked Buenos Aires-based GP Pharm to make the drug as part of an ongoing effort to win approval in Argentina.