PHILADELPHIA, May 31, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the “Company") announced today that it continues to build its manufacturing and scientific capabilities with the promotion of Carol Smith, Ph.D., as the Chief Manufacturing Officer and Deputy Chief Scientific Officer.
In this new role, which is critical to the company’s plan to increase Ampligen® production, Dr. Smith will be responsible for all manufacturing processes of Ampligen® and Alferon® to satisfy the Early Access Program (EAP) for pancreatic cancer and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as U.S.-based compassionate care programs such as AMP-511. She will work closely with Dr. David Strayer, Chief Scientific and Medical Officer, to assist in managing the Company's scientific, technological, and research operations.
“Due to the demand for Ampligen in the current EAP in pancreatic cancer and upcoming immuno-oncology studies, we felt that we needed a lead scientist with her depth of manufacturing experience to make sure that we can meet the demand for Ampligen,” said Thomas Equels, CEO of Hemispherx Biopharma. “This is a critical time for the company and increased production of Ampligen directly relates to incoming revenues. Dr. Smith has years of experience in the manufacture and fill-and-finish of GMP grade Ampligen and has worked with multiple contract manufacturers. She is a dynamic team leader. Dr. Smith clearly has the “right stuff” for this job.”
Prior to this promotion, Dr. Smith held several positions since joining the Company in 1991, including Manager of Quality, VP of Manufacturing and Process Development, and Manger of Quality Control. She has more than 35 years of experience in the biopharmaceutical industry involving the production of immuno-modulatory agents comprised of natural interferons and nucleic acids. Dr. Smith has been responsible for the technology transfer of the manufacture processes and analytical methodology for both the active pharmaceutical ingredients (API) and final drug products to contract manufacture organizations (CMO).
Dr. Smith earned a Ph.D. in Medical Sciences from the University of South Florida School of Medicine. She continued her graduate work in virology as a Post Doctorate Fellow at the Pennsylvania State University School of Medicine where her research concentrated on the anti-viral activity of natural interferons and other anti-viral agents in the discovery for medical treatments for Human Immunodeficiency Virus (HIV) and herpes viruses. Her responsibilities as Manager of Quality are being assumed by Victoria Scott, M.S., R.A.C. Director of Regulatory and Quality Assurance.
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 rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod is an experimental 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 both rintatolimod and Alferon® LDO are experimental in nature, they are not designated safe and effective by the FDA 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. Our Alferon N® approval in Argentina includes the use of Alferon N Injection® (under the pending brand name “Naturaferon”) for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Rintamod® has received approval in the Argentine Republic to treat severe cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). It will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. Hemispherx 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.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends,” “plans,” “potential,” “potentially,” “possible,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, below, market and other conditions, the impact of general economic, industry or political conditions in the United States or internationally, as well as the risks described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.
The information in this press release includes certain "forward-looking” statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States. The final results of these and other ongoing activities could vary materially from Hemispherx’s expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. The clinical studies referenced herein have been previously reviewed by the FDA and are not, in and of themselves, a sufficient basis for approval in the United States. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; our ability to adequately fund our projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; our ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of our patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in our filings with the Securities and Exchange Commission. The production of new Alferon® API inventory will not commence until the validation phase is complete. While the facility is approved by FDA under the Biological License Application (BLA) for Alferon®, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. The validation phase was delayed because of the damage caused by the flood that occurred in January 2016 at the facility. At this time, we believe that all repairs to the manufacturing facility have been completed. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. With regard to our NDA for Ampligen® to treat CFS, we note that there are additional steps which the FDA has advised us to take in our seeking approval. The final results of these efforts and/or any other activities could vary materially from our expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries. No evidence is suggested that Ampligen® will be commercially approved for any treatment or that Alferon N Injection® will be commercially approved for potential new treatment indications or for new manufacturing procedures. Approval of Rintamod® for CFS in the Argentine Republic does not in any way suggest that the Ampligen® NDA in the United States will obtain commercial approval. Also, it is noted that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely, additional steps required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing, etc., and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result in an overall successful commercialization and product launch). Expansion of the Early Access Program with myTomorrows into pancreatic cancer is no assurance of commercial approval in the US or elsewhere. No assurance can be given that Hemispherx will be able to sustain or increase revenues from the manufactured lots of Ampligen®.
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