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ORLANDO, Fla., April 17, 2018 (GLOBE NEWSWIRE) -- 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.
ME/CFS is a chronic and disabling biological disorder affecting millions worldwide. The direct and indirect economic costs of ME/CFS in the United States have been estimated at $17 to $24 billion per annum (Jason et al., 2008), $9.1 billion of which has been attributed to lost household and labor force productivity (Reynolds et al., 2004). There are no approved treatments for ME/CFS in the United States. Ampligen is the only drug in late-stage clinical development.
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.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Certain risks and uncertainties specifically related to this press release include the following: The above referenced recently filled and finished commercial sized lot is still subject to normal and routine release testing before it is available for commercial or clinical use. The Company believes that such testing will go well, however, any issues with such testing may affect the availability of vials for clinical and commercial uses and, as a result, our anticipated revenues. While we anticipate that we will have sufficient product to conduct U.S. clinical trials, we cannot predict the final number or type of trials that the FDA may request or other trials that may be necessary regarding Ampligen’s application to various cancers, nor can we predict the results of such studies. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Hemispherx Biopharma, Inc.
Phone Number: 800-778-4042
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