Hemispherx Biopharma Announces Completion of Ampligen® Manufacturing Technology Transfer Milestone
PHILADELPHIA, Oct. 19, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the "Company") announced today that it has completed its technology transfer of the Ampligen® manufacturing processes to Avrio Biopharmaceuticals ("Avrio"). The transfer consists of providing Avrio with all information that is relevant to the manufacturing process of Ampligen® and associated assays. This includes performing a test engineering run to identify any potential issues before moving forward with the first cGMP lot and confirming that the information exchange was successful. This will enable Avrio to begin manufacturing current Good Manufacturing Practice (“cGMP”) lots of Ampligen®. The first cGMP lot is expected to be compounded, filled and finished in November and released in December, 2016, for use in the Company’s Early Access Program (“EAP”) in Europe and Turkey.
/EIN News/ -- A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a341a509-8ec2-4ad9-aa0d-9f068cb33453
On July 27, 2016, Hemispherx announced that it had reached an agreement with Avrio, a contract manufacturer with the capabilities for the compounding and fill/finish of sterile, clinical and commercial grade Ampligen® to supply the Company's ongoing domestic clinical studies as well as the recently initiated EAP in Europe and Turkey. On October 11, 2016, Avrio announced that they have entered into a definitive agreement to be acquired by Avecia, a member of Nitto Denko Inc., a large, multi-discipline, Japanese based conglomerate. Avecia is a recognized leader in therapeutic nucleic acid manufacturing and development services with facilities located in Milford and Marlboro, Massachusetts, and Cincinnati, Ohio, offering services for DNA, RNA and other oligonucleotides based therapeutics.
"This is an important step in our initiative to increase Ampligen® manufacturing capabilities in order to ensure a stable supply for our ongoing clinical and early access programs,” said Thomas Equels, CEO of Hemispherx, “We look forward to working with Avecia, with their over 20 years of experience in development and production, and Hemispherx will be exploring areas of mutual interest in Japan. Much of the hallmark research in Ampligen® as a therapeutic and influenza vaccine enhancer has been done at the Japanese National Institute of Infectious Diseases by Professor Hideki Hasegawa. This is yet another milestone achievement on our production timeline, demonstrating our commitment and dedication to making Ampligen® available to ME/CFS patients through the EAP, to promote our plan to generate revenue for the company in 2017 and to obtain manufacturing approvals required in Argentina."
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 Rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod 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 Rintatolimod 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 pending brand name “Naturaferon”) for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Rintamod® has received approval in the Argentine Republic to treat severe cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). It will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. 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.
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”, “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.
The information in this press release includes certain "forward-looking” statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. 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® NDA in the United States and other countries. The clinical studies referenced herein have been previously reviewed by the FDA and are not, in and of themselves, a sufficient basis for approval in the United States. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.
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. Approval of Rintamod® for CFS in the Argentine Republic does not in any way suggest that the Ampligen® NDA in the United States will obtain commercial approval. Also, it is noted that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely, additional steps required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing, etc.), and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result in an overall successful commercialization and product launch.
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