Hemispherx Biopharma (NYSE MKT:HEB) announced today that it has reached an agreement with Avrio Biopharmaceuticals, Irvine California, to serve as an additional contract manufacturer of Hemispherx's experimental drug, Ampligen®, also known by its generic name rintatolimod. 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."
About Hemispherx Biopharma:
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information, please visit www.hemispherx.net.
About Avrio Biopharmaceuticals, LLC:
Avrio Biopharmaceuticals is a FDA inspected, premier contract development and manufacturing organization (CDMO) supporting the pharmaceutical, biopharmaceutical, and medical device industries with cGMP parenteral manufacturing and product development services from early phase through post-market life cycle management. Together with its affiliate Irvine Pharmaceutical Services, Avrio's comprehensive service offering includes aseptic manufacturing, lyophilization, formulation, analytical/biopharmaceutical development, structural chemistry, process validation, scale-up studies, stability storage and complete analytical CMC testing. Learn more at www.avriobiopharma.com.
