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Hemispherx Biopharma Announces Granting
of Final Settlement of Derivative and Class Action Case
PHILADELPHIA - September 22, 2016
- Hemispherx Biopharma (NYSE MKT: HEB) (the "Company"), announced today that the Court of Chancery of the State
of Delaware has issued an order granting final approval of a settlement of the derivative and class action case captioned Kastis,
et al. v. Carter, et al.
At a final settlement
hearing on September 19, 2016, the Court approved the settlement and awarded the plaintiffs' counsel $1.25 million in attorneys'
fees. No Company funds were used to pay the settlement or attorneys' fees award; the settlement was funded by Hemispherx's
insurance companies which paid to Hemispherx $3.5 million in settlement of several policy disputes, in part related to this claim,
that were in policy mediation. The final settlement does not constitute any admission of fault or wrongdoing by Hemispherx
or any of the individual defendants.
to close this chapter and move forward toward continued success in accomplishing our important corporate goals of developing and
commercializing Ampligen and Alferon," said Tom Equels, Hemispherx's CEO. "The net result of this order is that
substantial funds and management time are now free for business purposes, rather than litigation, and we have settled all pending
material litigation."
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 and the experimental therapeutics
rintatolimod (tradenames Ampligen or Rintamod ) and Alferon LDO. Rintatolimod 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. Because both Rintatolimod 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. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product
(Alferon N Injection ), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection
is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's
Alferon N approval in Argentina includes the use of Alferon N Injection (under the pending brand name "Naturaferon")
for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis
C infection. Rintamod has received approval in the Argentine Republic to treat severe cases of Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome (ME/CFS). It will be marketed by GP Pharm, Hemispherx's commercial partner in Latin America. 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 (intends", "plans", "potential",
"potentially", "possible" and similar expressions are intended to identify forward-looking statements.
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, below, 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.
The information in this press release includes
certain "forward-looking" statements including without limitation statements about additional steps which the FDA may
require and Hemispherx may take in continuing to seek commercial approval of the Ampligen NDA for the treatment
of Chronic Fatigue Syndrome in the United States. 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 in
the United States and other countries. The clinical studies referenced herein have been previously reviewed by the FDA and are
not, in and of themselves, a sufficient basis for approval in the United States. Any failure to satisfy the FDA regulatory requirements
or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen
NDA in the United States and other countries.
Information contained in this news release,
other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties
including, but not limited to, general industry conditions and competition; general economic factors; the Company's ability
to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States
and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory approval; the Company's ability to accurately
predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company's
patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions;
and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission.
The production of new Alferon API inventory will not commence until the validation phase is complete. While the facility is
approved by FDA under the Biological License Application ("BLA") for Alferon , this status will need to be reaffirmed
by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. The validation
phase is delayed until we are able to repair the damage caused by a flood that occurred on January 5, 2016 at the facility. While
we have made progress in repairing the damage at the facility, we cannot assure when all repairs required to be made prior to seeking
Pre-Approval Inspection by the FDA. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon
API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. With regard
to our NDA for Ampligen to treat CFS, we note that there are additional steps which the FDA has advised us to take in our
seeking approval. The final results of these efforts and/or any other activities could vary materially from Hemispherx's
expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly
delay, or preclude outright, approval of Ampligen in the United States and other countries. No evidence is suggested that
Ampligen will be commercially approved for any treatment or that Alferon N Injection will be commercially approved for
potential new treatment indications or for new manufacturing procedures. Approval of Rintamod for CFS in the Argentine
Republic does not in any way suggest that the Ampligen NDA in the United States will obtain commercial approval.
Also, it is noted that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely,
additional steps required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate
marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final
manufacturing, etc., and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed
to result in an overall successful commercialization and product launch.