Adamis Pharmaceuticals Announces License to Commercialize Tempol, a Novel Investigational Anti-inflammatory and Antioxidant D...
June 15 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today a license to commercialize Tempol, a novel
patented investigational drug for the treatment of Coronavirus
(COVID-19). The license includes the worldwide use of Tempol
for the treatment of all respiratory diseases including asthma,
respiratory syncytial virus, influenza and COVID-19. In
addition, the exclusive license includes the use of Tempol for
reducing radiation dermatitis in patients undergoing treatment for
cancer. A phase 2 radiation dermatitis clinical study has
already been successfully completed, as well as discussions with
FDA regarding the design of a pivotal phase 3 study. The license
was obtained from Matrix Biomed.
In consideration for Matrix providing the exclusive rights under
its patent rights and related know-how relating to Tempol within
the licensed fields, Adamis paid Matrix $250,000 following signing
of the definitive agreement. Adamis will also issue to Matrix
1,000,000 shares of Adamis convertible preferred stock, which will
be convertible into an equal number of shares of common stock after
and contingent on an increase in the number of available authorized
shares of common stock under the company’s restated certificate of
incorporation. Under the agreement, if any products are
commercialized, net profits will be equally distributed between the
parties.Coronavirus disease [Novel Coronavirus Disease (COVID-19),
a human betacoronavirus] represents a global health problem.
Just within the U.S., the American Hospital Association estimates
that the financial impact in losses for America’s hospital and
health care systems could exceed 200 billion dollars by
mid-2020. Therefore, identification of new drugs and
biologics for treating COVID-19 infection is urgently needed.
Most common symptoms at onset include fever, cough, sore throat,
sneezing, rhinorrhoea (runny nose) and fatigue. In severe
cases, this can progress to pneumonia, acute respiratory distress
syndrome (ARDS), acute cardiac injury and eventually death.
ARDS occurs when there is damage to the lungs resulting in fluid
accumulation in the small air sacs of the lungs. This fluid
causes a decrease in the oxygen supply to vital organs which can
eventually lead to death.Tempol has demonstrated anti-inflammatory,
anticogulant, and antioxidant activity. Tempol
specifically targets ARDS, which is the major cause of death of
COVID-19. Both inflammatory cytokines and reactive oxygent
species (ROS) generated from cells of the immune system
(macrophages and neutrophils) damage the lungs in ARDS
patients. In animal models, Tempol has been shown to decrease
proinflammatory cytokines (cytokine storm) such as TNF-α, IL-Iβ,
IL-6, IL-10, NF-kβ, ICAM-1, HIF-1a, HIF-2a and others. In addition,
Tempol works as an antioxidant and decreases the harmful effects of
ROS. ROS is a type of unstable molecule that contains oxygen and
easily reacts with other molecules in the cell. It can cause
damage to all macromolecules, i.e., lipids, DNA, RNA and
proteins. In addition, Tempol has also been shown to decrease
platelet aggregation and clotting, a problem observed in many
COVID-19 patients. Published articles describing animal models of
ARDS show Tempol to cause a decrease in lung inflammation and
preserve lung pathology associated with acute and chronic lung
injury. Additional published studies, in which animals were
infected with betacoronavirus, show that Tempol treatment resulted
in increased survival and decreased viral load. Taken together,
this scientific data argue for the use of Tempol in preventing and
treating the most severe death related lung manifestation of
COVID-19. Tempol has already been shown to be safe in
multiple human clinical studies. Dr. Dennis J. Carlo,
President and CEO of Adamis commented: “We are hopeful that Tempol
can be part of the solution to the current pandemic. We
believe that Tempol’s multiple modes of action such as an
antioxidant, an anticoagulant, and an anti-inflammatory may be more
beneficial than targeting a single pathological pathway. Tempol has
been the focus of numerous peer reviewed published articles by
highly respected scientists from various institutions such as:
Radiation Biology Branch of the National Cancer Institute, National
Institute of Health, FDA Center for Drug Evaluation and Research,
Georgetown University, University of Pittsburgh, University of
Pennsylvania, Weizmann Institute, Johns Hopkins University,
University of California San Diego, University of Texas and many
more. Tempol has been shown to be involved in cellular
metabolism, apoptosis, (form of programmed cell death or cellular
suicide), cell growth and development, stress response,
inflammation, and angiogenesis. Its role in decreasing
multiple pro-inflammatory cytokines and controlling both the
overactive inflammatory response and the cytokine storm could lead
to one treatment strategy that helps decrease the burden to our
health care system by reducing hospitalizations and potentially
saving the many lives of those infected with COVID-19.”Dr. Ronald
Moss, Chief Medical Office at Adamis, stated “The previously
published studies of Tempol provide a reasonable scientific
rationale to begin immediate clinical testing against COVID-19
during this pandemic. We plan on leveraging our depth of
clinical experience with respiratory viruses and government
collaborations to focus on this urgent public health problem.
To this end, Adamis will apply for government and other forms of
funding to conduct well designed clinical trials and will work
closely with FDA to expedite the testing. Our goal is to test
Tempol against COVID-19 as soon as possible. Clinical trial
material is currently available, since Tempol is an investigational
drug currently in human trials for other indications.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
respiratory disease, allergy and opioid overdose. The company’s
SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine)
Injection 0.15mg products were approved by the FDA for use in the
emergency treatment of acute allergic reactions, including
anaphylaxis. Please refer to www.SYMJEPI.com for additional
product information. Adamis is developing additional
products, including a naloxone injection product candidate, ZIMHI,
for the treatment of opioid overdose, and a metered dose inhaler
and dry powder inhaler product candidates for the treatment of
asthma and COPD. The company has entered into a distribution
and commercialization agreement with US WorldMeds for the US
commercial rights for SYMJEPI and ZIMHI. The company’s
subsidiary, U.S. Compounding, Inc., compounds sterile prescription
drugs for human and veterinary use, and certain nonsterile drugs
for use by hospitals, clinics and surgery centers throughout most
of the United States.
Adamis Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those that
express plans, anticipation, intent, contingencies, goals, targets
or future development and/or otherwise are not statements of
historical fact. These statements relate to future events or
future results of operations, including, but not limited to the
following statements: the company's beliefs concerning the safety
and effectiveness of the compounds and drugs described in this
press release; the results of any future clinical trials that the
company or Matrix may conduct relating to the compounds and drug
product candidates described in this press release; the company’s
ability to fund future product development and trials; future
revenues expected from any products that may be developed and
approved for marketing by the FDA and other regulatory authorities;
the company’s ability to commercialize the product candidates
described in this press release, itself or through
commercialization partners; the company’s beliefs concerning the
safety and effectiveness of any product candidates that may be
developed; and the intellectual property protection that may be
afforded by any of the licensed patents or patent applications.
Such forward-looking statements include those that express
plans, anticipation, intent, contingencies, goals, targets or
future development and/or otherwise are not statements of
historical fact. These statements are only predictions, are
not guarantees, involve known and unknown risks, uncertainties and
other factors, and concern matters that could subsequently differ
materially from those described in this press release, which may
cause Adamis' actual results to be materially different from those
contemplated by these forward-looking statements. There can
be no assurances regarding the timing, cost or outcome of any
current or future trials that may be conducted relating to the
compounds and products described in this press release. There
can be no assurances that we or any commercialization partners will
file any New Drug Applications with the FDA regarding any of the
compounds or products described in this press release, or that any
such NDAs will be approved by the FDA. In addition,
forward-looking statements concerning our anticipated future
activities assume that we can obtain sufficient funding to support
such activities and continue our operations and planned
activities. As discussed in our filings with the Securities
and Exchange Commission, we may require additional funding, and
there are no assurances that such funding will be available if
required. We cannot assess the impact of each factor on our
business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements. You should not
place undue reliance on any forward-looking statements.
Further, any forward-looking statement speaks only as of the date
on which it is made, and except as may be required by applicable
law, we undertake no obligation to update or release publicly the
results of any revisions to these forward-looking statements or to
reflect events or circumstances arising after the date of this
press release. Certain of these risks, and additional risks,
uncertainties, and other factors are described in greater detail in
Adamis’ filings from time to time with the SEC, including its
annual report on Form 10-K for the year ended December 31, 2019,
and our subsequent filings with the SEC, which Adamis strongly
urges you to read and consider, all of which are available free of
charge on the SEC's web site at http://www.sec.gov.
Contacts:
Mark FlatherSenior Director, Investor Relations& Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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