Adamis Pharmaceuticals Announces Pre-IND Feedback from FDA Enabling Advancement of Tempol, a Novel Anti-Inflammatory and Anti...
August 14 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today that in response to Adamis’ Pre-Investigational New
Drug (IND) filing with the U.S. Food and Drug Administration (FDA),
the FDA has provided detailed comments regarding the prospective
use of Tempol in a randomized placebo controlled trial. The FDA’s
response now allows Adamis to proceed to the next step of formally
submitting an IND for Tempol, and at the same time, begin formal
applications for funding to governmental agencies to support the
clinical trial and large-scale manufacturing.
Dr. Dennis J. Carlo, President and CEO of Adamis stated: “After
submitting an extensive clinical protocol entitled ‘Preventing
COVID-19 Related Hospitalizations in Subjects with COVID-19
Infection’, we received thoughtful and comprehensive guidance from
the FDA. We believe that Tempol’s unique antioxidant and
anti-inflammatory activity, and its ability to inhibit the
“cytokine storm” in pertinent animal models, makes it a strong
candidate for the potential treatment of COVID-19. By protecting
healthy cells, Tempol may delay or prevent disease progression and
hospitialization.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, respiratory and inflammatory disease. The company’s
SYMJEPI (epinephrine) Injection products are approved by the FDA
for use in the emergency treatment of acute allergic reactions,
including anaphylaxis. Adamis’ naloxone injection product
candidate, ZIMHI, for the treatment of opioid overdose is currently
under FDA review with a target action date of November 15, 2020. In
May 2020, the Company announced a partnership with US WorldMeds for
the commercialization of SYMJEPI and, if approved by the FDA,
ZIMHI. Adamis is developing additional products, including
treatments for acute respiratory diseases, such as COVID-19,
influenza, asthma and COPD. The company’s subsidiary, U.S.
Compounding, Inc., compounds sterile prescription drugs, and
certain nonsterile drugs for human and veterinary 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 or product candidates described in
the press release; the timing of commencement of completion of any
clinical trials relating to Tempol; the results of any future
clinical trials that the company or may conduct relating to Tempol;
the company’s ability to apply and obtain government or other
funding for clinical trials relating to Tempol or the timing or
amount of any such funding; the company’s ability to commercialize
the product candidates described in this press release, itself or
through commercialization partners; and other statements concerning
our future operations and activities. 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 or outcome of our submission of an IND relating to a
clinical trial for Tempol, regarding the timing or the outcome of
our applications for government or other funding for clinical
trials relating to Tempol; concerning the timing or outcome of any
such clinical trials; or that Tempol will be found to be safe and
effective in the treatment of COVID-19 or any other indication. In
addition, forward-looking statements concerning our anticipated
future activities assume that we are able to 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 will 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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