Adamis Pharmaceuticals Provides Update Regarding ZIMHI
February 19 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today
provided an update on the ZIMHI™ New Drug Application (NDA)
resubmission process.
On November 22, 2019, Adamis received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration (FDA) regarding
its NDA for its ZIMHI high-dose naloxone injection product for the
treatment of opioid overdose. On December 22, 2019, the
company announced that it had provided responses to the comments
raised in the CRL and had also requested a Type A meeting.
The FDA scheduled the meeting for the second week of
February. On February 12, 2020, Adamis met with the agency to
discuss the CRL, Adamis’ responses and to determine the best path
forward for ZIMHI.
At the face to face meeting, the Company obtained concurrence
from the agency on the Chemistry, Manufacturing and Controls (CMC)
information required for resubmission of the NDA. The
additional information involves extractables and leachables testing
from the syringe and glassware. In addition, the potential
public health role of ZIMHI (high dose naloxone) in the current
opioid epidemic was also discussed. The Company believes it can
generate the additional information and resubmit the NDA early in
the second quarter of 2020. The FDA expressed its intent to review
the resubmission in a rapid and timely manner. Adamis will
provide the next update on the ZIMHI NDA after the resubmission is
accepted.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We
are thankful to the Agency for expediting our meeting request and
we are very pleased with the outcome of the meeting. Most
fatal drug overdoses in the U.S. are attributable to potent
synthetic opioids like fentanyl. Therefore, we believe there
is an urgent need for higher dose forms of naloxone such as ZIMHI
to combat the increasing potency of these opioids. We are
committed to expeditiously complete the work required to resubmit
our NDA and we remain committed to bringing ZIMHI to the
market.”
About ZIMHI
ZIMHI is a high-dose naloxone injection product candidate
intended for the treatment of opioid overdose. Naloxone is an
opioid antagonist and is generally considered the drug of choice
for immediate administration for opioid overdose. It works by
blocking or reversing the effects of the opioid, including extreme
drowsiness, slowed breathing, or loss of consciousness. Common
opioids include morphine, heroin, tramadol, oxycodone, hydrocodone
and fentanyl. According to statistics published by the Centers
for Disease Control and Prevention (CDC) in 2017, drug
overdoses resulted in approximately 72,000 deaths in the
United States – greater than 195 deaths per day. Drug
overdoses are now the leading cause of death for Americans under
50, and more powerful synthetic opioids, like fentanyl and its
analogues, are responsible for the largest number of deaths from
opioid overdoses.
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 both use the same injection device as
used for ZIMHI and 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. In addition to its ZIMHI (naloxone) injection
product, Adamis is developing other products, including 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. 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 its ability to
satisfactorily respond to the matters raised in the FDA’s Complete
Response Letter (CRL) and to successfully develop the additional
information requested by the FDA at the Type A meeting; the results
of the company’s Type A meeting with the FDA and the
results of that meeting; the company’s beliefs concerning the
results of any future studies or clinical trials that the company
may conduct relating to ZIMHI or its other products or product
candidates; the company’s beliefs concerning the information and
activities required to resubmit the ZIMHI NDA to the FDA, the
timing of resubmission of the company’s NDA to
the FDA and the timing and outcome of the FDA’s review of
any resubmitted NDA relating to the ZIMHI product; the company’s
beliefs concerning its ability to commercialize ZIMHI and its other
products and product candidates; the company's beliefs concerning
the ability of its product candidates to compete successfully in
the market; the company's beliefs concerning the safety and
effectiveness of ZIMHI or its other products and product
candidates; the company’s beliefs concerning its commercialization
strategies; and the company’s beliefs concerning the anticipated
timing of any commercial launch of its ZIMHI product. 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. There can be no assurances that
the results of the additional company testing will be
successful, that the company will be able to successfully develop
the additional information required for resubmission of the NDA, or
concerning the timing of completion of testing and development of
the additional information for resubmission of the NDA. In
addition, there can be no assurance that the FDA will conclude
that any NDA that the company resubmits will satisfactorily
respond to the matters raised in the FDA’s CRL or discussed in the
Type A meeting, or concerning the timing of any resubmission by
Adamis of the NDA, that the FDA will approve our NDA
relating to our ZIMHI product or concerning the timing of any
future action by the FDA on our NDA, regarding the
commercialization options that the company will pursue if our NDA
is approved, or that the product will be able to compete
successfully in the market if approved and launched. 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. 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, 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,
any forward-looking statements in this press release speak only as
the date of this press release, and Adamis expressly disclaims any
obligation to update any forward-looking statements.
Contact Adamis: Mark Flather Senior Director,
Investor Relations& Corporate Communications (858)
412-7951mflather@adamispharma.com
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