Adamis Pharmaceuticals Provides an Update on ZIMHI
December 19 2019 - 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, the company received a Complete Response
Letter (CRL) from the U.S. Food and Drug Administration (FDA)
regarding its NDA for Adamis’ ZIMHI™ high-dose naloxone injection
product for the treatment of opioid overdose. The company has
provided responses to the comments included in the CRL and
submitted these answers to the FDA this week. With the responses,
the company requested a Type A meeting with the agency and is
currently waiting for the FDA to respond to this request. The next
update from the company on the ZIMHI NDA resubmission process will
be sometime after the FDA meeting occurs. At that time, the company
would expect to have more information regarding the timeline for
the full resubmission of the NDA back to the FDA.
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); the timing of the company’s requested Type A
meeting to discuss the CRL 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 timing of resubmission of the company’s New
Drug Application (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 FDA
will conclude that the company’s submitted responses to the
comments included in the CRL are satisfactory, that company will be
able to satisfactorily respond to the matters raised in the FDA’s
CRL or concerning the timing of any resubmission by Adamis of the
NDA responding to the CRL, 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
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Sep 2023 to Sep 2024