Adamis Pharmaceuticals Strengthens Patent Portfolio for Its Naloxone Product Candidate
18 February 2021 - 1:00AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company")
today announced that it recently received a notice that one of its
patent applications relating to its ZIMHI™ high dose naloxone
injection product candidate, intended for the treatment of opioid
overdose, was allowed by the U.S. Patent and Trademark Office. The
allowed claims describe a naloxone composition at a dose greater
than or equal to five milligrams configured for administration as
an injection. The company believes this patent should protect and
strengthen the existing intellectual property associated with the
product candidate.
According to new data from the U.S. Centers for Disease Control
and Prevention (“CDC”), deaths from drugs overdoses have
substantially accelerated amid the COVID-19 pandemic. The CDC data
indicates that more than 81,000 drug overdose fatalities occurred
in the U.S. between June 2019 and May 2020. This is the highest
number of overdose deaths ever recorded in a year-long period.
These numbers are expected to increase.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, added, “The current opioid epidemic seems
to be fueled by the more potent synthetic opioids such as fentanyl
and its derivatives, and it has worsened during the COVID-19
pandemic. Concomitant with the rise of overdoses caused by
synthetic opioids, deaths have risen despite increased availability
of the current naloxone product. Administratively, too little too
late can be life-threatening. The CDC has noted the need for
multiple doses of the current nasal naloxone product, which
suggests that a higher dose product may be necessary for the
successful resuscitation of overdose victims. Additionally, there
is concern that administering the nasal product could potentially
put caregivers at risk of contracting COVID-19.
“Our 5 mg dose of naloxone delivered by intramuscular or
subcutaneous injection has demonstrated significantly higher
availability (naloxone in the blood) at 2.5 and 5 minutes (critical
period) when compared to the current FDA-approved product. This
should translate into more successful reversal of toxicity caused
by higher potency synthetic opioids and potentially save many
lives. We look forward to meeting with the FDA to discuss the
responses that we have submitted to the agency to the issues raised
in the most recent complete response letter relating to our New
Drug Application for ZIMHI, and will continue to work with the FDA
towards our goal to get ZIMHI approved.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, 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. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma and COPD. The company’s subsidiary,
US Compounding Inc., compounds sterile prescription drugs, and
certain nonsterile drugs for human and veterinary use by hospitals,
clinics, surgery centers, and vet clinics throughout most of the
United States. Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to future events or our future
results of operations or future financial performance, including,
but not limited to the following statements: the extent of
intellectual property protection that may be afforded by any issued
patents or patent applications relating to ZIMHI product or the
company’s other products and product candidates; the severity of,
and reasons for, the current opioid crisis; the company’s beliefs
concerning the safety or effectiveness of its ZIMHI product; the
company’s beliefs concerning the ability of its ZIMHI product to
reverse toxicity caused by higher potency synthetic opioids and
potentially save lives; the company's beliefs concerning the
ability of its product candidates to compete successfully in the
market; the company’s beliefs concerning its ability to
satisfactorily respond to the matters raised in the FDA’s complete
response letter (“CRL”); the company’s beliefs concerning the
information, data and actions that the FDA may require in
connection with responding to the most recent CRL relating to ZIMHI
or resubmitting the company’s New Drug Application (NDA) relating
to ZIMHI; the company’s beliefs concerning the timing and outcome
of any meeting with the FDA or appeal and formal dispute resolution
process that the company may initiate; the company’s beliefs
concerning the timing and outcome of the FDA’s review of the
company’s NDA relating to the ZIMHI product or any resubmitted NDA;
and the results of any future clinical trials that the company may
conduct relating to ZIMHI. Statements in this press release
concerning future events depend on several factors beyond the
company's control, including receipt of adequate funding to support
these activities, the absence of unexpected developments or delays,
market conditions, and the regulatory approval process. The FDA may
require additional studies, or other actions, data or information,
prior to any resubmission of the NDA. There can be no assurances
that the company will be able to satisfactorily respond to the
matters raised in the FDA’s CRL or concerning the timing of any
resubmission by us of the NDA responding to the CRL, concerning the
timing or costs of any additional actions that may be required in
connection with any resubmission of the NDA, that the FDA will
approve any resubmitted NDA relating to our ZIMHI product or
concerning the timing of any future action by the FDA on our NDA,
that the company will be successful in any formal dispute
resolution appeal process with the FDA, or that the product will be
able to compete successfully in the market if approved and
launched. These statements are only predictions and involve known
and unknown risks, uncertainties and other factors, which may cause
Adamis' actual results to be materially different from these
forward-looking statements. Certain of these risks, uncertainties,
and other factors are described in greater detail in Adamis'
filings from time to time 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. Except to the extent
required by law, Adamis expressly disclaims any obligation to
update any forward-looking statements. The company does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this press release.
Contact AdamisMark FlatherSenior Director,
Investor Relations& Corporate CommunicationsAdamis
Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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