Promotes Carol Smith, Ph.D., to Manager of Quality as Part of Manufacturing Optimization
Retains Step Change Pharma as Advisor to Strengthen Manufacturing and Technical Infrastructure
Retains Former Director of Research & Development, Joseph C. Horvath, M.D., as Scientific Advisor
PHILADELPHIA, July 19, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the “Company") announced today that it has bolstered its manufacturing and scientific capabilities with the promotion of Carol Smith, Ph.D., as Manager of Quality, the engagement of Step Change Pharma as an advisor to strengthen manufacturing and technical infrastructure, and the retention of Joseph C. Horvath, M.D., as a scientific advisor.
Dr. Smith will be responsible for all quality control and quality assurance for the manufacturing of Ampligen® and Alferon. She has more than 32 years of experience in the process development, manufacturing, and testing of antiviral drug products such as natural human alpha interferon, monoclonal antibodies, and double-stranded nucleic acids. She served as the Director of Manufacturing for alpha interferon and Manager of Quality Control in the biotech and pharmaceutical industries prior to joining Hemispherx as the Quality Control Manager in Rockville, Maryland in 1991. Since then, Dr. Smith has held several positions at Hemispherx, including Director of Manufacturing and Process Development for Ampligen® at the Rockville facility and VP of Operations as the Company expanded to the New Brunswick, New Jersey facility. She has played a critical role in the development of the analytical release test methods and in the development of the commercial manufacturing processes for Ampligen® and intermediate raw materials for Ampligen® at Contract Manufacturers (CMOs) and at the Hemispherx facility in New Brunswick. Dr. Smith has been involved in the successful inspection by the European Union of the manufacturing and quality control operations and in the successful FDA pre-approval inspection of the Ampligen® CMO in Spokane, Washington. Dr. Smith received a Ph.D. from the University of South Florida Medical School in Tampa, Florida, and an NIH Fellowship to continue her research endeavors at Hershey Medical in Hershey, Pennsylvania.
Step Change Pharma will be advising the Company on all forms of regulatory compliance and cGMP. The firm specializes in process design, re-design, and development; process analytical technology (PAT); quality by design (QbD); regulatory innovation (CMC assessment); establishing and advising regulatory process for interaction with regulatory bodies with the goal of helping companies maintain regulatory compliance; and preparation for FDA inspections and approvals. The firm’s principle, Ali Afnan, Ph.D., was a member of the Food and Drug Administration’s Drug Product Quality Initiative. He was a senior member of the agency’s PAT policy team and co-author of PAT Guidance, and is a former member of the team responsible for drafting and finalizing Process Validation Guidance.
Dr. Horvath will be advising the Company on scientific aspects of development, manufacturing, and regulatory of the Company’s clinical-stage candidates. Before re-joining the Company as a consultant, he served Hemispherx as the Director of Research and Development from 2007 – 2015 when his responsibilities included process development, method development, analytical method validation, among other related activities. Prior to joining Hemispherx, Dr. Horvath was the Scientific Director of the Biotherapeutic Research Laboratory at St. Joseph’s Hospital Cancer Institute in Tampa, Fla. where he was responsible for drafting clinical protocols and informed consent forms for clinical trials. His research resulted in 94 scientific publications. Dr. Horvath earned an M.D. at Semmelweis University Medical School in Budapest.
“The objective of enhancing the roles of these experienced professionals to the Hemispherx team are to make their vital manufacturing and scientific skill sets maximally available to the Company as we focus on advancing our two key assets, Alferon N Injection® and Ampligen®,” said Thomas Equels, CEO of Hemispherx Biopharma. “We look forward to their collective contributions as we approach the re-initiation of manufacturing at our New Brunswick facility and the further advancement of our drug candidates.”
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.
Forward-Looking Statements:
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 “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, 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.
Disclosure Notice:
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; the Company’s ability to adequately fund its 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; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s 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 the Company’s 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 is delayed until we are able to repair the damage caused by a flood that occurred on January 5, 2016 at the facility. While we have made progress in repairing the damage at the facility, we cannot assure when all repairs required to be made prior to seeking Pre-Approval Inspection by the FDA. 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 Hemispherx’s 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. No assurance can be given that new management’s new business plan and focus will prove successful.