Hemispherx Biopharma Europe N.V./S.A. : Orphan Medicine Designation and European Medicines Agency Public Opinion Summary Published by EMA Regarding Alferon N Injection® as a Treatment of Middle East Respiratory Syndrome (MERS)
The EMA has approved the opinion of the Committee for Orphan Medicinal Products (COMP) that the medicinal product, interferon alfa-n3, satisfies the criteria for designation and established that no satisfactory method for treating MERS was authorized in the EU at the time of designation.
The PSO also states that, “This medicine contains a type of interferon called interferon alfa-n3. Interferons are natural substances produced by the body that have a number of actions; one of these is to help fight off viruses. The Middle East Respiratory Syndrome virus overcomes the body’s natural defenses by stopping the body’s own interferons from working properly.” It is hypothesized that giving additional interferon in the form of interferon alfa-n3 may help to restore the body’s defense against the virus.
Middle East Respiratory Syndrome (MERS) was first identified in Saudi Arabia in 2012, and is an illness caused by a coronavirus known as the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Infection can cause severe acute respiratory illness with symptoms of fever, cough, and shortness of breath as well as death. Some infected people developed pneumonia and experienced gastrointestinal symptoms including diarrhea, nausea/vomiting, and kidney failure. MERS has a fatality rate of 38% and the mean time from onset to death is 12 days.
About Alferon® Alferon® is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® is approved in the U.S. 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 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 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 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; as well as numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. 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 final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. For instance, 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. The re-launch of Alferon N as a commercial product cannot commence until all regulatory approvals have been obtained.
Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, are based upon the current beliefs and expectations of the Company’s management, are subject to significant risks and uncertainties 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, 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 Injection® will ever be commercially approved for the new potential treatment indications mentioned in this release.
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