Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA
May 18 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
the resubmission of the Company’s New Drug Application (“NDA”) to
the U.S. Food and Drug Administration (“FDA”) for its ZIMHI™
(naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the
treatment of opioid overdose. The resubmission follows the
company’s meeting with the agency in February and is intended to
address the issues raised by the FDA in the agency’s November 2019
Complete Response Letter (“CRL”).
Adamis previously announced that it entered into an exclusive
distribution and commercialization agreement with US WorldMeds, LLC
(“USWM”) for commercial rights for the ZIMHI product candidate.
Under the terms of the agreement, USWM obtained U.S.
rights to commercialize and distribute the ZIMHI, if approved by
the FDA, in exchange for an upfront payment and potential
regulatory and commercial milestones totaling up to $26 million.
Additionally, Adamis and USWM will share equally in the
net profits, as defined in the agreement. Adamis has retained
rights to commercialize the ZIMHI product outside the U.S. and
may also continue to develop its injection platform for additional
product candidates. Additional information concerning the agreement
and the transaction is contained in a report on Form 8-K that has
been filed by the company with the Securities and Exchange
Commission.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated,
“We have been encouraged by our interactions with the FDA following
our CRL and are pleased to resubmit our ZIMHI NDA. Based on the
feedback from our Type A meeting in February, we conducted
additional product testing with the goal of addressing the
Chemistry, Manufacturing and Controls deficiencies discussed in the
CRL. I feel the additional data addresses all the issues raised in
the November CRL and we hope the FDA can expedite its review. With
the rapid increase in synthetic opioid related deaths and the
persistence of widespread opioid addiction, we believe that there
remains a need for a higher dose treatment option to help combat
this crisis.”
About ZIMHIZIMHI 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 2018, drug overdoses resulted in
approximately 67,000 deaths in the United States –
greater than 185 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. On May 11, 2020,
Adamis announced it entered into an exclusive distribution and
commercialization agreement with USWM for U.S. commercial rights
for the ZIMHI product.
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. 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 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. These statements relate to future events or future results of
operations, including, but not limited to the following matters:
the timing or outcome of the FDA’s review of the company’s
resubmitted NDA relating to its naloxone product candidate and
whether the FDA will approve the resubmitted NDA; the company’s
beliefs concerning its ability to commercialize the naloxone
product candidate if approved and commercialized; the company’s
beliefs concerning the size of the markets in which the product
candidate will compete if approved; the company’s beliefs
concerning the safety and effectiveness of its products and product
candidates; the Company’s beliefs concerning its exclusive
distribution and commercialization agreement with USWM, LLC for
U.S. commercial rights for the ZIMHI product and whether milestone
payments and net profit share payments will be made pursuant to
that agreement; 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. The timing and outcome of the FDA’s review of our NDA
is uncertain. There is no assurance that the FDA will
approve the NDA relating to our naloxone product candidate (or any
other NDA that we file) or that other matters or events relating to
the submission and regulatory review process under Section
505(b)(2) of the Food, Drug & Cosmetic Act will not differ from
our expectations or result in delays in the regulatory approval
process. There are no assurances that the FDA will regard our
resubmitted NDA as satisfactorily responding to the matters raised
in the earlier CRL or in our Type A meeting with the FDA in
February 2020. The FDA could issue another CRL, require additional
studies or information, or take other actions other than approval
of our resubmitted NDA. Receipt of an additional CRL or other
adverse action by the FDA concerning our NDA could result in
significant additional time and expense before our ZIMHI NDA is
approved, if approved at all, and marketing of ZIMHI could
commence. There are no assurances concerning the amount of
milestone payments or net profit share payments that we may receive
in the future pursuant to our agreement with USWM. 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 our filings from
time to time with the SEC, including our 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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