Adamis Pharmaceuticals Announces Presentation of ZIMHI data at IHV Scientific Meeting
October 08 2019 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today the presentation of data pertaining to its
investigational high dose naloxone product (ZIMHI) at the Institute
of Human Virology (IHV) meeting
(http://www.ihv.org/ihvmeeting/Program/) in a session on “Opioid
Intersection”. Other participants at the meeting included Dr.
Robert Gallo, Co-Founder and Director, Institute of Human Virology,
Dr. Nora Volkow, Director, National Institute of Drug Abuse,
National Institutes of Health, and Admiral Brett Giroir, MD,
Assistant Secretary for Health, US Department of Health and Human
Services. The Adamis data was presented by Dr. Ronald Moss, Chief
Medical Officer at Adamis.
Naloxone is an opioid antagonist that competes opioids off their
receptors in the brain. Rapid and efficient reversal by naloxone is
critical as brain injury and death can occur within minutes.
Adamis presented data comparing the pharmacokinetics of ZIMHI to
current doses of naloxone products (Evzio, Narcan, and generic
Naloxone). ZIMHI had significantly higher and more rapid levels of
naloxone in the blood compared to the other products.
Adamis also presented data on a model that simulated various
overdoses due to the more potent synthetic opioids such as
fentanyl. ZIMHI was shown in the model to rapidly compete out
fentanyl from the receptors in the brain while current doses took
longer. The model suggested that at higher doses of fentanyl
overdose, higher doses of naloxone, such as are contained in ZIMHI,
can potentially result in a more rapid and successful
resuscitation.
Dr. Dennis J. Carlo, President and CEO of Adamis commented on
the presentation: “We believe these data suggest that ZIMHI should
be useful in the current opioid epidemic, where the more potent
synthetic opioids continue to cause deaths. We are hopeful that if
our ZIMHI product candidate is approved and commercialized, both
patients and first responders will have access to a higher dose
naloxone product, which should lead to saving more lives”.
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, and both were fully launched in the U.S. in
July 2019. 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’s subsidiary, U.S. Compounding,
Inc., compounds sterile prescription drugs, and certain nonsterile
drugs for patients, animals, 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. 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 timing and outcome
of the FDA’s review of the company’s NDA relating to its
ZIMHI™ (naloxone) Injection product candidate; the data and
interpretation of the data from the company’s studies pertaining to
the company’s ZIMHI product candidate; the company’s ability
to commercialize its product and product candidates, itself
or through commercialization partners; the company’s beliefs
concerning the ability of its products and product candidates to
compete successfully in the market; the company’s beliefs
concerning the safety and effectiveness of its products and product
candidates; 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 the outcome of the
FDA’s review process. There can be no assurances that
the FDA will agree with our interpretation of study data,
will approve our NDA relating to our naloxone product candidate or
will give final approval to our proposed brand name for the
product, concerning the timing of any such approval, that the
product will be commercially successful if approved and introduced,
or concerning the outcome of any discussions with third parties
concerning commercialization of the product.
The FDA review process is subject to a number of
uncertainties. The FDA’s review processes can extend beyond,
and in some cases significantly beyond, anticipated target PDUFA
action dates due to the timing of the FDA’s review process, FDA
requests for additional data, information, materials or
clarification, difficulties scheduling an advisory committee
meeting, FDA workload issues, extensions resulting from the
submission of additional information or clarification regarding
information already in the submission within the last three months
of the target PDUFA date, such as submission of the results of the
company’s PK study, or other reasons. As a result, the dates of
regulatory approval, if obtained, and commercial introduction of
our product could be delayed beyond our expectations. 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 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, 2018,
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 Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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