PHILADELPHIA, May 21, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced the preliminary stage agreement required to manufacture Ampligen® in Argentina in order to serve Latin American markets should Ampligen® be approved in Argentina. The aforementioned agreement is another important step moving forward in Argentina and South America pursuant to our Sales, Marketing, Distribution and Supply Agreement for Ampligen® with GP Pharm. The agreement is a prerequisite to the company starting the manufacture of stability lots, followed by stability testing, necessary to gain ANMAT's approval to manufacture Ampligen, contingent upon ANMAT approval. The parties are also actively discussing establishing a manufacturing capacity for Alferon® N in Argentina.
In June 2010, the parties entered into a Sales, Marketing, Distribution and Supply Agreement for Ampligen® in certain Latin American countries. In December 2010, the parties extended this agreement to cover Mexico. In August 2012, the parties announced they had filed for approval of Ampligen® by Administración Nacional de Medicamentos, Alimentos y Tecnología Médica ("ANMAT") to treat Chronic Fatigue Syndrome ("CFS"). This application is pending and there can be no guarantee that Ampligen® will be approved in Argentina or in any other country.
In December 2010, the parties entered into a Sales, Marketing, Distribution, and Supply Agreement with respect to Hemispherx's natural interferon, Alferon® N, the only FDA approved natural interferon for the treatment of refractory HPV genital warts. In August 2011, the parties announced they had filed for approval by ANMAT of Alferon® N for treatment of this condition. In January 2012, ANMAT approved Alferon® N for this indication. In October 2012, the parties announced they had applied to ANMAT for an extended treatment indication for Alferon® N. This approval, for any patient nonresponsive to recombinant interferon, was thereafter approved by ANMAT in March 2013, significantly broadening the Alferon® N label of approved treatments.
Jorge Braver, CEO of GP Pharm, stated "This agreement is important for an Argentinian pharmaceutical company because it establishes the potential to manufacture products which originate outside Argentina. This agreement has the potential to create jobs in Argentina and import technology and expertise in the pharmaceutical and biopharmaceutical fields and will expand our presence, over time, in new South American markets pending approval."
Thomas Equels, Executive Vice Chairman of Hemispherx, stated "We see this as a logical expansion of our relationship with GP Pharm in Latin America which also provides Hemispherx with backup manufacturing as well as a means for making and supplying products to Latin America. This is an excellent synergy of the assets of both companies."
About GP Pharm Argentina
GP Pharm SA International headquarters are located in Barcelona, Spain with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research, development and marketing of injectable products made by partners and by GP Pharm SA based on its proprietary drug delivery systems which includes microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.
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.
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, 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
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA, ANMAT, and any other regulatory agencies may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® for the treatment of Chronic Fatigue Syndrome in the United States, South America, or any other countries. The manufacturing agreement does not in any way guarantee the approval of Ampligen® in South America, nor does it in anyway guarantee the ability to manufacture or supply Ampligen to provide the South American 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.