PHILADELPHIA, June 25, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE:HEB) (the "Company" or "Hemispherx"), announced that it received formal notice on June 18, 2015, that the European Patent Office's Examining Division issued the formal notification of intention to grant the Hemispherx application titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" by inventors Carter, et al. and assignee Hemispherx Biopharma, Inc. The patent claims a novel form of rugged dsRNA. Rugged dsRNA are nucleic acids with a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities. This form of dsRNA has increased bioactivity and binding affinity to the TLR 3 receptor because of its reduced tendency to form branched dsRNA that can inhibit receptor binding. Pharmaceutical formulations containing this nucleic acid as active ingredients, and methods of treatment with those formulations, are also described in the accepted application.
Hemispherx' Executive Vice Chairman, Thomas Equels, states, "We are pleased to announce this significant step in our business plan for Ampligen. The EPO's formal written communication states, 'You are informed that the Examining Division intends to grant a European patent....' Success at this critical first stage is important for implementation of our global program for Ampligen and, while final formal approval by the member nations is still pending, this formal notification by the EPO of the intention to grant the composition of matter patent is an essential first step in that approval process."
With this important milestone achieved, the patent application is expected to be granted by the EPO in the near future and will thereafter enter a national validation phase taking several months which may include review and approval by up to approximately 25 countries. A similar application (U.S. patent 8,722,874) was granted in the U.S. on May 13, 2014.
An earlier U.S. composition-of-matter patent on Ampligen®, an experimental biotherapeutic, was issued to Johns Hopkins University with results published in the Journal of Molecular Biology, and thereafter licensed to Hemispherx Biopharma, Inc. exclusively. Upon expiration of the original patent, Hemispherx relied on a continued research program and sizable portfolio of subsequently issued related patents to maintain a degree of proprietary protection for novel compositions and treatment methods based on Ampligen® technology. With issuance of U.S. Patent 8,722,874, and this significant progress with the EPO, Hemispherx Biopharma's planned patent protection for novel formulations of Ampligen® products may extend through 2029 and potentially beyond.
Patent extension is a possibility in the U.S., because of patent law provisions (commonly known as the "Hatch-Waxman Amendments"), which permit patent extensions in certain cases to partially compensate for patent life lost due to a lengthy clinical drug development cycle. Hemispherx is presently engaged in multiple clinical trials in the U.S. related to Chronic Fatigue Syndrome (CFS) (AMP-511), enhancement of immune responses to influenza vaccines, and various immunotherapies for human cancers. Similar clinical studies are projected for the European Union and Australia under various collaborative agreements.
To augment potential responses in CFS, Hemispherx has identified an immune marker characteristic of many patients with severe CFS (http://www.hemispherx.net/content/investor/default.asp?goto=812) which responds favorably to Ampligen® treatment in vitro.
For previously, largely untreatable cancers, Hemispherx has identified potential therapeutic regimens that combine Ampligen with newly proven immunotherapeutics with the goal of increasing overall effectiveness and survival. These new immunotherapeutics are also called "check-point inhibitors" because they unleash the human immune apparatus to accelerate the killing of human tumor cells.
The recently issued U.S. patent, and its potential counterparts in the EU, indicate how dsRNAs acting through TLR3 receptor activation are potent antiviral compounds and anticancer agents and through secondary immunomodulators have the potential to enhance the bioactivity of vaccines and treat autoimmune diseases.
The significant extension of proprietary longevity via the new composition-of-matter patent in the U.S. and the application now accepted by the EU is expected to favorably affect patent longevity of Ampligen® in potentially up to an additional 25 countries.
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 Company's Alferon® N 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.
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, 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.
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA and other regulatory agencies may require and Hemispherx may take in continuing to seek commercial approval of Ampligen® in the United States, Europe, South America, or any other countries. The novel patent does not in any way guarantee the ability to manufacture or supply Ampligen® to various markets due to the potential for delays in approvals or the inability to manufacture Ampligen®.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® in any of these countries. Any failure to satisfy these regulatory agencies requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries. 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 final results of these efforts and/or any other activities could vary materially from Hemispherx's expectations.
CONTACT: Company/Investor Contact: Charles Jones CJones & Associates Public Relations firstname.lastname@example.org 1-888-557-6480Source:Hemispherx Biopharma, Inc.