Hemispherx Biopharma (HEB) Completes Transfer for Ampligen Manufacturing Processes

October 19, 2016 8:34 AM EDT
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Hemispherx Biopharma (NYSE: HEB) announced that it has completed its technology transfer of the Ampligen manufacturing processes to Avrio Biopharmaceuticals ("Avrio"). The transfer consists of providing Avrio with all information that is relevant to the manufacturing process of Ampligen® and associated assays. This includes performing a test engineering run to identify any potential issues before moving forward with the first cGMP lot and confirming that the information exchange was successful. This will enable Avrio to begin manufacturing current Good Manufacturing Practice (“cGMP”) lots of Ampligen®. The first cGMP lot is expected to be compounded, filled and finished in November and released in December, 2016, for use in the Company’s Early Access Program (“EAP”) in Europe and Turkey.

On July 27, 2016, Hemispherx announced that it had reached an agreement with Avrio, a contract manufacturer with the capabilities for the compounding and fill/finish of sterile, clinical and commercial grade Ampligen® to supply the Company's ongoing domestic clinical studies as well as the recently initiated EAP in Europe and Turkey. On October 11, 2016, Avrio announced that they have entered into a definitive agreement to be acquired by Avecia, a member of Nitto Denko Inc., a large, multi-discipline, Japanese based conglomerate. Avecia is a recognized leader in therapeutic nucleic acid manufacturing and development services with facilities located in Milford and Marlboro, Massachusetts, and Cincinnati, Ohio, offering services for DNA, RNA and other oligonucleotides based therapeutics.

"This is an important step in our initiative to increase Ampligen® manufacturing capabilities in order to ensure a stable supply for our ongoing clinical and early access programs,” said Thomas Equels, CEO of Hemispherx, “We look forward to working with Avecia, with their over 20 years of experience in development and production, and Hemispherx will be exploring areas of mutual interest in Japan. Much of the hallmark research in Ampligen® as a therapeutic and influenza vaccine enhancer has been done at the Japanese National Institute of Infectious Diseases by Professor Hideki Hasegawa. This is yet another milestone achievement on our production timeline, demonstrating our commitment and dedication to making Ampligen® available to ME/CFS patients through the EAP, to promote our plan to generate revenue for the company in 2017 and to obtain manufacturing approvals required in Argentina."



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