The US drugmaker announced it had finished upgrading its facility in New Brunswick this week, explaining that it had replaced the six 100 litre bioreactors with a single 600 litre unit and cut its manpower requirement by 80%.
The facility will produce Hemispherx its genital wart treatment Alferon N Injection, which was approved by the US FDA in 1998 but has been off the market since 2008 after the cost of producing it became too high.
Unlike recombinant interferons made in genetically modified bacteria, Alerfon is a so called ‘natural interferon’ made up of a mixture of different versions of the molecule harvested from white cells collected from blood banks.
Hemispherx claims its mixture may be more effective against a wider range of viruses that recombinant interferons.
A spokesman told Biopharma-reporter.com that Hemispherx plans to make the drug available again and added that “We are anticipating a successful FDA Pre Approval Inspection by the second half of 2015.”
He explained that “Hemispherx’s solely owned facility in New Brunswick is the only supplier of Alferon” adding that, in addition to the US market, the plant will make the drug for South American marketing and sales partner GP Pharm.
But the New Brunswick site could end up shipping Alferon to locations even further as the drug is one of two Hemispherx compounds being tested by the US army scientists as a treatment for Ebola infection.
In trials at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Maryland, Alferon low concentrations of Alferon “successfully protected human cells against the Ebola virus.”
The army scientists also tested Ampligen, an double-stranded (ds) RNA therapeutic being developed by Hemispherx, also successfully protected human cells against the Ebola virus.
USAMRIID said it “plans to continue to collect data and to initiate in-vitro synergy studies using Alferon and Ampligen.”
A Hemispherx spokesman told us that “the New Brunswick facility has the capacity to manufacture Alferon for Ebola studies.”