Source: Hemispherx Biopharma, Inc. 4/17/18
Hemispherx Biopharma, Inc. (NYSE
American:HEB), an immuno-pharma R&D and emerging commercial growth
company focused on unmet medical needs in immunology, is pleased to
announce that it has successfully achieved a developmental milestone
with the completed production of a commercial-size batch of more than
8,500 vials of Ampligen®, its drug candidate that has been accorded
Orphan Drug Product Designation by the FDA for the treatment of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The Company
announced that following its “Fill & Finish” at the Contract
Manufacturing Organization (CMO), the batch is now undergoing routine
release testing prior to shipment.
Hemispherx plans to generate substantial revenues from this large batch through an existing 2,100 vial stock order from myTomorrows for its early access programs. Further, this batch will supply the initial demand for the anticipated commercial launch of Ampligen in Argentina, where it is approved for treatment of severe ME/CFS. The recent Argentine approval is the first-ever approval of a drug for severe ME/CFS. Additionally, this large lot meets the Company’s projected needs for clinical trials of Ampligen in the United States, including the FDA-approved compassionate care program in ME/CFS, and clinical trials involving various cancers with Ampligen as a stand-alone therapy as well as in combination with checkpoint blockade technology.
“This accomplishment is an important milestone for Hemispherx. Team Hemispherx has demonstrated it can compound its polymers into filled and finished commercial-size lots, thereby setting the ground for dramatically expanding revenues in the coming months. Additional commercial-sized lots are scheduled and we are moving full speed ahead,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “This further demonstrates our ability to produce commercial-scale lots of Ampligen, thereby paving the way to better serve those with dire unmet medical needs.”
Hemispherx announced in January 2018 that it had polymers, equivalent to approximately 18,000 vials of Ampligen, ready to compound fill and finish at its CMO. The more than 8,500 vials recently successfully filled and finished at our CMO were derived from a portion of these polymers.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include the FDA approved drug Alferon N Injection® and the Argentina approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials, however, Ampligen has been approved in Argentina for ME/CFS and the company is working toward legal access in other countries where early access programs exist for serious diseases such as ME/CFS where there are unmet medical needs. Ampligen is the only therapy approved anywhere in the world for ME/CFS. Also, an Ampligen EAP approval has been obtained for therapeutic use in the Netherlands for pancreatic cancer.
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