PHILADELPHIA, May 31, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma. Inc. (NYSE MKT:HEB) announced today that it executed a renewed Sales, Marketing, Distribution and Supply Agreement for Argentina with GP Pharm Latino America (GP Pharm), an affiliate company of Spanish GP Pharm SA (www.gp-pharm.com). The previous agreement had expired on June 14, 2015. Under this new agreement, GP Pharm will be responsible for gaining regulatory approval in Argentina for Ampligen®, an experimental therapeutic, to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and for commercializing Ampligen® for this indication in Argentina. The Company has granted GP Pharm expanded rights to sell this experimental therapeutic into other Latin American countries based upon GP Pharm achieving certain performance milestones. The Company has also granted GP Pharm an option to market Alferon N Injection® trademarked in Argentina as Naturaferon®, its FDA approved natural interferon, in Argentina and other Latin America countries. In 2012, under GP’s original agreement they were able to extend Alferon’s indication in Argentina to treat any disease that is refractory to Recombinant Interferon. Under this Agreement, the Company will manufacture and supply Ampligen® and Alferon® to GP Pharm.
Thomas K. Equels, Hemispherx CEO, said, “The renewal of the GP Pharm agreement is in anticipation of the upcoming ruling from ANMAT on our pending application for Ampligen’s approval to treat CFS/ME. Since Hemispherx has no operation in Argentina it needs GP Pharm as its local representative in order for ANMAT to finalize its review and potentially provide Hemispherx an approval of Ampligen to treat CFS/ME patients in Argentina. Should we obtain this approval, we expect that it will also have a dramatic beneficial effect on our early access program partnerships which we have developed in Europe and Australia”.
Jorge Braver of GP Pharm said, “Thousands of people suffer from ME/CFS, a particularly insidious disease for which there is no known cure, in Argentina and elsewhere in Latin America. We are looking forward to expanding our relationship with Hemispherx by undertaking the commercialization of Ampligen® in Latin America. We are also excited to have the opportunity to market the FDA approved product, Alferon N Injection®, a natural interferon with a proven track record of safety and historically demonstrated anti-viral capabilities, throughout Latin America.”
About GP Pharm Argentina
Headquartered in Barcelona, GP Pharm SA has operations in each major country in Latin America either directly or through local partners. Its activities are focused on the research, development and marketing of injectable products made by others and by GP Pharm SA based on its proprietary drug delivery systems including microspheres and liposomes. GP Pharm’s new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of its own products and 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.
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. 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 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; 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 the validation phase is complete. While the facility is approved by FDA under the Biological License Application ("BLA”) for Alferon®, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. The validation phase is delayed until we are able to repair the damage caused by a flood that occurred on January 5, 2016 at the facility. At this moment, there is no definitive timetable to have the facility back online. 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 to allow commercial sales to resume. With regard to our NDA for Ampligen® to treat CFS, we note that there are additional steps which the FDA has advised us to take in our seeking approval. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. 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. No assurance can be given that GP Pharm’s endeavors on behalf of the company will enable the company to dispense and eventually sell Alferon or Ampligen ® for the treatment of Chronic Fatigue Syndrome (CFS) in its territory. No evidence is suggested that Ampligen® will be commercially approved for any treatment or that Alferon N Injection® will be commercially approved for potential new treatment indications or for new manufacturing procedures.
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 “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.