PHILADELPHIA, March 2, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") announced today that its manufacturing site located in New Brunswick, New Jersey, presently configured at over 43,000 square feet, has completed its $8 million of upgrades. These upgrades will provide for a higher capacity, more cost effective manufacturing process for the production of Alferon N Injection®, the only FDA-approved natural alpha interferon. The added efficiency of the process has been accomplished by integrating continuous flow manufacturing technology throughout the process. This has led to improved cost efficiency, enhanced yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety as seen in other cutting edge pharmaceutical companies.
The upgraded facility is installed with a 600-liter bioreactor instead of a labor-intensive method using 100 x 6 liter flasks for the same size batch. Scaling up to the automated 600-liter bioreactor has eliminated ~ 80% of the manpower previously needed for this part of the process.
In March 2008, the company halted the manufacturing and marketing of Alferon N Injection® due to the high labor cost for manufacturing Alferon® and the low capacity significantly limiting the commercialization potential of Alferon N Injection®. The original process, producing the Alferon® in hundreds of small flasks, was extremely labor intensive. The upgraded manufacturing facility which uses a 600-liter bioreactor will provide a cost effective process and provide the capacity to supply both the US and South American market. The FDA will need to re-affirm the amended Biological License Application (BLA) for the facility before the commercial sales of Alferon N Injection® are recommenced. The company is anticipating having commercial product available for distribution by Armada Healthcare by late 2015.
According to industry sources, global sales of interferon (from multiple manufacturers) was approximately $7.8 billion in year 2013, with about two-thirds of global sales generated in the US. A review summarized and analyzed the clinical outcomes following treatment of a wide range of diseases with recombinant interferons (r-IFNs) and/or natural interferons (n-IFNs) (Strayer, et al. Recombinant and Natural Human Interferons: Analysis of the Incidence and Clinical Impact of Neutralizing Antibodies. J Interferon Cytokine Res 2012;32(3):95-102).
About Alferon® N
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities ("biological modifiers") for treatment of seriously debilitating disorders especially life-threatening viruses. 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 including cancers. 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 .
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. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries 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 validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. 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 manufactured in the upgraded facility. The final results of these efforts could vary materially from Hemispherx's expectations. Dr. David Strayer is the Medical Director of Hemispherx Biopharma and author of the referenced review article.
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 "intends," "plans," 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, above, 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. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.
Company/Investor Contact Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email:
