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| You can stop hitting me now... |
What
follows is the full text of Hemispherx Biopharma's press release.
Anyone who has been following the long, long history of Ampligen vs.
The World, won't be surprised that, yet again, HB has been trounced.
To be fair, the odds were slightly tilted in favor of the FDA and the
multi-billion dollar industry it represents. (FYI: I have italicized the touching section in which HB expresses "concern" for our health. Apparently, Bob Miller got their attention. Good job, Bob! Next time, I'll join you.)
PHILADELPHIA, Feb 04, 2013
(GLOBE NEWSWIRE via COMTEX) -- Hemispherx Biopharma, Inc. (nyse
mkt:HEB) (the "Company" or "Hemispherx"),
announced that it received a Complete Response Letter from the US
Food and Drug Administration ("FDA") declining to approve
its new drug application ("NDA") for Ampligen for Chronic
Fatigue Syndrome ("CFS"). The FDA said Hemispherx should
conduct at least one additional clinical trial, complete various
nonclinical studies and perform a number of data analyses.
In its Complete Response
Letter ("CRL"), the FDA set forth the reasons for this
action and provided recommendations to address certain of the
outstanding issues. The Agency stated that the submitted data do not
provide substantial evidence of efficacy of Ampligen for the
treatment of CFS and that the data do not provide sufficient
information to determine whether the product is safe for use in CFS
due to the limited size of the safety database and multiple
discrepancies within the submitted data.
In the two pivotal clinical
studies that form the basis of approval for Ampligen, Hemispherx
believes that the primary efficacy endpoints were met and that they
showed a statistically significant improvement (i.e., with a p-value
of 0.05 or less). The FDA and Hemispherx do agree that in clinical
study AMP-502, the primary endpoint was met (p=0.02). In clinical
study AMP-516, the FDA's analysis resulted in a p-value of 0.10,
while Hemispherx's calculation resulted in a p-value of <0.05, and
yet both analyses indicate that those patients on Ampligen improved
over those on placebo. With regard to safety, Hemispherx has provided
data from the 845 subjects who have received Ampligen, including 589
subjects suffering from severe CFS and over 200 CFS patients who have
received Ampligen for at least one year or longer. The Company
believes that these data are sufficient to determine the safety
profile of Ampligen. At the December 20, 2012 FDA Advisory Committee
meeting, 8 of the 13 Advisory Committee members voted yes on the
question of "Is the safety profile of Ampligen adequate for
approval for the treatment of CFS?"
Hemispherx plans to request
an end-of-review conference with the FDA as a precursor to submitting
a formal appeal to the Office of New Drugs in the FDA's Center for
Drug Evaluation and Research regarding the Agency's decision. The
purpose of the conference is to review all of the issues raised in
the Agency's CRL as well as to discuss the corroborating data and
experiences of clinicians and patients who have seen the benefits of
Ampligen therapy.
Hemispherx has become aware
that a prominent CFS advocate and long-time CFS sufferer, who has
been on Ampligen since 1999 through a treatment IND, began a hunger
strike on January 30, 2013 to seek FDA approval of Ampligen.
Hemispherx understands the frustration that there is still no
FDA-approved treatment for CFS and the concern that patients may lose
access to Ampligen therapy. Out of concern for the health of the CFS
community, Hemispherx has asked any hunger strikes be discontinued
and that patients join in a collaborative effort between the FDA,
Hemispherx, CFS clinicians and patient advocates to find a solution
to this significant unmet medical need.
In the past, the FDA has
shown great willingness to work with stakeholders to find solutions
for serious and life-threatening illnesses. Dr. Margaret Hamburg,
Commissioner of the FDA has previously stated that, "FDA has an
important role to play in shaping the future of medical breakthroughs
by bringing stakeholders together to identify and overcome
challenges." Hemispherx hopes that the FDA will view the
Ampligen end-of-review conference as an opportunity to involve
patient advocacy, clinicians and researchers in a concentrated effort
to do something for these patients over the near-term, including
further evaluation of how new legislation, such as the recently
enacted "FDASIA" statute, may have a role in finding a
solution. The views of one internationally recognized
researcher/clinician, Dr. Nancy Klimas, who has over 20 years'
experience evaluating and treating CFS patients, can be found at
http://www.sciencedaily.com/releases/2013/01/130124183448.htm
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, including the
aforementioned end-of-review conference and appeals process, which
the FDA may require and Hemispherx may take in further seeking 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. Any
failure to satisfy the FDA's requirements could significantly delay,
or preclude outright, approval of the Ampligen NDA.
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 (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 "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, including its
intent to pursue the end-of-review conference and appeals process.
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 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 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.
