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Class Action Lawsuit Against Hemispherx Biopharma is Without Merit

* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:45 am EST, Monday November 16, 2009
Companies:
o Hemispherx Biopharma, Inc.

PHILADELPHIA, Nov. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") said the recently filed lawsuit is without merit. The lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.
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On July 7, 2008 the Company received the following letter from the Department of Health and Human Services, Food and Drug Administration, which stated:


"Please refer to your April 25, 2008 new drug application (NDA)
submitted under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act for Ampligen (poly I: poly C12U) 2.5 mg/mL Sterile
Solution in 80mL.

We also refer to your submissions dated June 13 and 17, 2008.

We have completed our filing review and have determined that your
application is sufficiently complete to permit a substantive review.
Therefore, in accordance with 21 CFR 314.101(a), this application
is considered filed 60 days after the date we received your
application. The review classification for this application is
standard. Therefore, the user fee goal date is February 25, 2009".
(Emphasis supplied)

Upon receipt of an NDA, the FDA reviewers conduct a filing review to determine whether the application is sufficiently complete to warrant a substantive review. During that filing review, the agency may identify matters involving the organization of the application, needed clarification or additional information which need to be addressed before the agency will decide to formally file the application and begin its substantive review. As reflected in the letter quoted above, FDA informed the Company of the agency's decision to file the Ampligen NDA on July 7, 2008.

Apart from matters affecting the filing decision, the FDA reviewers may, at any time during the review of an NDA, request additional information or clarification of previously submitted information. Such requests made during the course of the NDA review are, by the FDA policy, not considered a determination by the FDA of the status of the NDA or of the prospects for approval of the NDA during the current review cycle (see "Guidance for Industry, Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act" November, 2001). A determination of whether or not any outstanding matters need to be resolved prior to approval is only made, through established internal agency processes, at the end of the review. That determination is made by responsible supervisory reviewers and officials with delegated agency authority, in light of all of the completed reviews, based in part on a risk-benefit analysis which takes into account the clinical importance of the drug and the condition being treated, the strength of the supporting data, and the significance of any potentially outstanding matters. Only at that time is a determination made whether any remaining matters need to be resolved prior to approval or can be properly addressed through available alternative regulatory options or post-approval requirements or commitments.

This is why the cited Guidance explicitly states that an end-of-review action letter may omit matters raised in interim communications (even if they were not addressed by the sponsor) and may include new matters that were never raised in interim communications.

Although, as previously disclosed, FDA reviewers have made inquiries and requested clarification or additional information in connection with their ongoing review of the Ampligen NDA, the FDA reviewers did not seek additional information from the Company either with respect to extension of the first PDUFA date of February 25, 2009, or the second PDUFA date extension on May 25, 2009, and have not indicated in any way that either such extension was related to the need for submission of additional clarification or data. Moreover, based on numerous published reports and statements by Agency officials, it is the Company's understanding that, during the past two years, the Agency has increasingly failed to meet established PDUFA goals due to resource limitations and competing priorities which have often prevented timely completion of NDA reviews (see the FDA presentation, New Drug Review: 2008 Update, available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm117686.pdf ).

As stated in its recent earnings release of November 9, 2009, the FDA has not informed the Company as to any outstanding responses required in order to take action on the pending NDA.

Thus, the class action fraud claim is false. The FDA has in writing stated, "We have completed our filing review and have determined that your application is sufficiently complete to permit a substantive review." Further, the FDA has not sought new information from the Company either with respect to extension of its first PDUFA date of February 25, 2009, or with respect to its second PDUFA date extension on May 25, 2009.

About Hemispherx Biopharma

Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and potentially life-threatening disease with which a new retrovirus was recently associated. Researchers are investigating the possible role of this virus in the symptomatology of the disease using Ampligen(R) as an investigational therapeutic.

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) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 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.

Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such 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. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.

Contact:

Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
[e-mail]