Avrio, an FDA inspected facility, has the capabilities for the compounding and fill/finish of sterile clinical and commercial grade Ampligen to satisfy the Company's ongoing domestic clinical studies as well as the recently initiated Early Access Program (EAP) in Europe and Turkey.
This agreement with Avrio should allow Hemispherx to rapidly replenish its Ampligen®/rintatolimod inventory. Serving the EAP, outside of the United States, is especially important because it has the potential to generate positive cash flow on EAP transactions while Hemispherx seeks commercial approval for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States, Argentina, and elsewhere.
Thomas Equels, Hemispherx CEO, commented, "We are pleased to be working with Avrio, a well-respected professional team that is highly motivated to support our short term goal of accelerated manufacturing of Ampligen® to serve our clinical initiatives and the EAP, as well as partner with us for the long haul.
"Avrio, as an additional CMO for Ampligen, provides price efficiencies, very rapid turnarounds, and a safety net of redundancy. Maintaining a supply of clinical grade Ampligen is one of our top priorities since many individuals with severe ME/CFS continue to seek Ampligen availability through our access programs."
Dr. Assad Kazeminy, CEO of Avrio Biopharmaceuticals, noted, "The new relationship with Hemispherx represents an exciting addition to our well-established client portfolio. We are delighted with the Hemispherx decision, and strongly believe that Hemispherx's manufacturing strategy is an excellent match to Avrio's core competencies."