PHILADELPHIA, July 27, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the “Company") announced today that it has reached an agreement with Avrio Biopharmaceuticals (“Avrio”), Irvine California, to serve as an additional contract manufacturer of Hemispherx’s experimental drug, Ampligen®, also known by its generic name rintatolimod. Avrio, an FDA inspected facility, has the capabilities for the compounding and fill/finish of sterile clinical and commercial grade Ampligen® to satisfy the Company’s ongoing domestic clinical studies as well as the recently initiated Early Access Program (EAP) in Europe and Turkey. This agreement with Avrio should allow Hemispherx to rapidly replenish its Ampligen®/rintatolimod inventory. Serving the EAP, outside of the United States, is especially important because it has the potential to generate positive cash flow on EAP transactions while Hemispherx seeks commercial approval for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States, Argentina, and elsewhere.
Thomas Equels, Hemispherx CEO, commented, “We are pleased to be working with Avrio, a well-respected professional team that is highly motivated to support our short term goal of accelerated manufacturing of Ampligen® to serve our clinical initiatives and the EAP, as well as partner with us for the long haul. Avrio, as an additional CMO for Ampligen®, provides price efficiencies, very rapid turnarounds, and a safety net of redundancy. Maintaining a supply of clinical grade Ampligen® is one of our top priorities since many individuals with severe ME/CFS continue to seek Ampligen® availability through our access programs.”
Dr. Assad Kazeminy, CEO of Avrio Biopharmaceuticals, noted, “The new relationship with Hemispherx represents an exciting addition to our well-established client portfolio. We are delighted with the Hemispherx decision, and strongly believe that Hemispherx’s manufacturing strategy is an excellent match to Avrio’s core competencies.”
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 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.
About Avrio Biopharmaceuticals, LLC:
Avrio Biopharmaceuticals is a FDA inspected, premier contract development and manufacturing organization (CDMO) supporting the pharmaceutical, biopharmaceutical, and medical device industries with cGMP parenteral manufacturing and product development services from early phase through post-market life cycle management. Together with its affiliate Irvine Pharmaceutical Services, Avrio’s comprehensive service offering includes aseptic manufacturing, lyophilization, formulation, analytical/biopharmaceutical development, structural chemistry, process validation, scale-up studies, stability storage and complete analytical CMC testing. Learn more at www.avriobiopharma.com.
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, 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:
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. While we have made progress in repairing the damage at the facility, we cannot assure when all repairs required to be made prior to seeking Pre-Approval Inspection by the FDA. 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 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. No assurance can be given as to if or when ANMAT will approve Ampligen® for the CFS indication.