Thomas Equels, Executive Vice Chairman, stated: "We anticipate that there will be an ongoing increase in both expenses and in net cash used relating to company-wide efforts seeking FDA approval of the Ampligen ® NDA for Chronic Fatigue Syndrome ("CFS")." Hemispherx recently met with the FDA as reported on July 11, 2012 (please see http://www.hemispherx.net/content/investor/default.asp?goto=734 ). At that meeting, Hemispherx reached agreement on the filing requirements for the Company's complete response to the FDA's November 25, 2009 Complete Response Letter ("CRL"). The FDA also agreed to accept, for review, further analyses of data from the previously conducted Ampligen ® clinical trials in lieu of the additional Phase III study originally called for in the CRL, although there can be no assurance the FDA will conclude the data are adequate to support approval of Ampligen ®. On July 31, 2012, Hemispherx filed with the FDA its complete response which begins a six month review cycle at the FDA (please see http://www.hemispherx.net/content/investor/default.asp?goto=736 ). Mr. Equels added, "Since no drug has yet received FDA approval to treat CFS, we are committed to working with the FDA as well as making an all-out effort by our staffs in New Jersey and Philadelphia, along with the necessary and appropriate investment in additional personnel, equipment and other resources, in the hope of getting a treatment approved for people who must live with this severely debilitating condition."
Hemispherx continued to move forward with enhancements to its FDA licensed manufacturing facility in New Brunswick, NJ to accommodate larger production volumes of its FDA-approved therapeutic, Alferon N Injection ®. The project is continuing its construction phase with approximately $4,335,000 having been spent from project commencement through June 30, 2012 as compared to $1,695,000 from project commencement through December 31, 2011.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain FDA approval of the Ampligen ® 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 ® 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 complete response Hemispherx submitted in support of the Ampligen ® NDA may not be accepted by the FDA or such acceptance may be delayed; (ii) the FDA may ask for additional data, information or studies to be completed or provided prior to approval; (iii) 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; and (iv) 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. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen ® NDA.
About Hemispherx BiopharmaHemispherx 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 ® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen ® and Alferon ® LDO. 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 with the referenced disorders. 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. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection ®). 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 . 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 "anticipate," "hope," 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. 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: Dianne Will Hemispherx Biopharma, Inc. 518-398-6222 firstname.lastname@example.org
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