AmpligenTreatment for Chronic Fatigue Syndrome
Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome
PHILADELPHIA, Sept. 24, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. today announced that the U.S. Food and Drug Administration ("FDA") has tentatively scheduled an Advisory Committee ("AC") meeting to discuss the Ampligen(R) New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. The date of the AC review has been tentatively set for December 20, 2012. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review is February 2, 2013.
Recently, the FDA has become increasingly active in working with the CFS and Myalgic Encephalomyelitis ("ME") communities. On September 13, 2012, a teleconference organized by Dr. Janet Woodcock, Director of the Center for Drug Evaluation & Research ("CDER"), was held between the FDA, patients, advocacy organizations and other stakeholders. As the FDA explained during that teleconference, it plans to host an "Excellency in Advocacy" webinar in mid-November 2012 that is intended to "advise patient advocates or advocacy groups on how to come together and develop common themes to ultimately further [their] mutual goals and be beneficial to everyone." In the Spring of 2013, the FDA plans to hold a workshop "to explore a multitude of scientific issues about identifying valid, reliable and measurable outcomes to determine if disease symptoms improve with intervention." (A transcript of the September 13, 2012 teleconference is available at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf). Further discussion on the FDA's activities can be found in a September 13, 2012 article, "Chronic Fatigue Syndrome Drug Development Efforts Get A Boost From FDA" from "The Pink Sheet" DAILY.
During the September 13, 2012 teleconference, Sandra L. Kweder, M.D., Deputy Director, CDER Office of New Drugs stated that the FDA considers CFS/ME to be a "serious and life threatening condition" and that the FDA is "committed to making promising drugs available to individuals with serious diseases as quickly as possible for the rapid development and review of these types of therapy." As noted previously, Hemispherx also believes that the FDA's recently expanded statutory authority under the Food and Drug Administration Safety and Innovation Act ("FDASIA") may be relevant to the potential for approval of Ampligen(R), although there can be no assurance how the FDA will implement the new FDASIA provisions.
DISCLOSURE NOTICE: The information in this press release and the article referenced therein includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain FDA approval of the Ampligen(R) NDA for the treatment of Chronic Fatigue Syndrome. 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(R) NDA. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed or provided prior to approval; (ii) the FDA may require additional work related to the commercial manufacturing process to be completed prior to approval or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved; (iii) the FDA may determine that the complete response submitted by Hemispherx is not "complete," potentially requiring the Company to conduct additional activities before it can re-file, if at all, the complete response; and (iv) until completion of the FDA review of the Ampligen(R) NDA, including the Advisory Committee review, and final approval of the product and prescribing information, if any, the specific patient population for which Ampligen(R) may be indicated will not be known. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen(R) NDA. In addition, the FDA's plans for the December 20, 2012 Advisory Committee review are tentative and are subject to change.
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Because both Ampligen(R) and Alferon(R) 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 with the referenced disorders. Ampligen(R) 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. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). 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 "believes," "plans," "anticipates," and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations and represent the Company's judgment as of the date of this release. 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 and Hemispherx's beliefs that the Ampligen(R) NDA may be covered by the new provisions of the FDASIA statute, which are subject to FDA interpretation and implementation, or that such provisions, if applicable, will be helpful with regard to obtaining FDA approval of the Ampligen(R) NDA. 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.
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Hemispherx Biopharma, Inc.
Posted: September 2012
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- Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen - March 7, 2008
- Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA - January 9, 2008
- Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome - October 11, 2007