AmpligenTreatment for Chronic Fatigue Syndrome
Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
PHILADELPHIA, Oct. 22, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (the "Company" or "Hemispherx") today announced that the U.S. Food and Drug Administration ("FDA") has scheduled for December 20, 2012 a meeting of the Arthritis Advisory Committee ("AAC") to discuss the Ampligen New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review is February 2, 2013.
The AAC meeting will be held from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993-0002. Further details are available at https://federalregister.gov/a/2012-25878.
The announcement of the December 20, 2012 AAC meeting follows the FDA's September 13, 2012 teleconference on CFS and Myalgic Encephalomyelitis ("CFS/ME"), the transcript of which is available at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf. In addition, on October 25, 2012, the FDA is holding a public meeting to discuss the patient-focused drug development initiative, one of its performance commitments under PDUFA V, which is intended to establish a more systematic approach to obtaining patient perspective on certain diseases. CFS is one of 39 diseases nominated for such review. Also, in the Spring of 2013, the FDA is scheduling a workshop on the development of treatments for CFS/ME.
About Arthritis Advisory Committee
The AAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases, and makes appropriate recommendations to the Commissioner of Food and Drugs. It consists of a core of 11 voting members including the Chair.
Information about the AAC can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
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.
CONTACT: Company/Investor Contact:
Hemispherx Biopharma, Inc.
Posted: October 2012
- Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome - February 5, 2013
- FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome - December 27, 2012
- Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome - September 24, 2012
- FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome - August 14, 2012
- Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome - August 1, 2012
- 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