×

Hemispherx Biopharma Europe N.V./S.A. Receives Positive Opinion on Application for Orphan Designation by the European Medicines Agency for Alferon N Injection to Treat Patients With Middle East Respiratory Syndrome (MERS)

PHILADELPHIA, Oct. 19, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”) announces that the European subsidiary, “Hemispherx Biopharma Europe N.V./S.A.” gained a positive opinion from the COMP (Committee on Medical Products) regarding its Orphan Medicinal Product Application for Alferon N Injection® to treat Middle East Respiratory Syndrome (MERS).

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c731594b-487e-4283-b512-7d674d66f48a

The COMP is of the opinion that the medicinal product satisfies the criteria for designation and the sponsor has established that there exists no satisfactory method of treatment of MERS. The COMP, therefore, recommends the granting of orphan medicinal product designation for Alferon N Injection® in respect to the MERS indication.

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 people infected 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.

The EU Orphan application process consists of multiple steps and a final decision from the European Commission normally occurs sometime after the summary report of the COMP. No assurances can be given that the final decision will designate Alferon N Injection® as an Orphan Medical Product for treatment of MERS.

"Alferon has great experimental potential as an early onset therapeutic for this dread disease. Hemispherx is dedicated to making Alferon available for MERS clinical trials, emergency uses and early access programs consistent with all applicable laws," according to Tom Equels, Hemispherx' President.

About Alferon N Injection®
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. 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 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® and any potential income derived therefrom in the United States and other countries. The re-launch of Alferon N, as a commercial product and any potential income derived therefrom in the United States and other countries 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 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: cjones@cjonespr.com

Source:Hemispherx Biopharma, Inc.