Adamis Pharmaceuticals Provides Business Update
June 01 2021 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
biopharmaceutical company developing and commercializing specialty
products for respiratory disease, allergy and opioid overdose,
today provided the following business update.
“The bulk of our focus during the first quarter was on preparing
for the Type-A meeting with the FDA regarding our New Drug
Application for ZIMHI naloxone injection product intended for the
treatment of opioid overdose. Based on feedback received in that
meeting, we resubmitted the NDA in May,” stated Dennis J. Carlo,
Ph.D., President and Chief Executive Officer of Adamis
Pharmaceuticals. “We have also been preparing to begin patient
enrollment in a Phase 2/3 clinical trial to evaluate the use of
Tempol in patients with COVID-19.”
Product and Pipeline Updates and Other Corporate
Developments
SYMJEPI® (epinephrine) Injection
- Since completing the transition of SYMJEPI from Sandoz in the
fourth quarter of 2020, Adamis’ new commercial partner, US
WorldMeds, continues to make gains in the epinephrine market.
- In January, both SYMJEPI products became available through the
Walgreens Prescription Savings Club at a discounted price of $99.99
per two-pack.
- Based on third-party market data, the Company believes SYMJEPI
unit sales have increased approximately 90% for the five months
from December 2020 through April 2021 compared to the same
five-month period of the prior year, since transitioning the
product from Sandoz.
- Adamis expects the Walgreens arrangement, along with other
commercial initiatives currently underway, will continue the
positive trend on sales of SYMJEPI products for the remainder of
2021.
ZIMHI (naloxone) Injection
- During the first quarter 2021, Adamis submitted responses to
the FDA to address the deficiencies identified in the complete
response letter (CRL) relating to the Company’s ZIMHI New Drug
Application (NDA), along with a request for a Type-A meeting with
the agency.
- The Company met with the FDA in April to discuss the responses
and the regulatory path forward for ZIMHI.
- Based on the discussions and feedback from the agency, Adamis
resubmitted its NDA for ZIMHI to the FDA in May and is currently
awaiting an agency response and a new action date.
Tempol
- In February, the Company’s Investigational New Drug Application
(IND) relating to a protocol for a clinical trial of Tempol in
COVID-19 patients received FDA clearance to begin clinical
testing.
- The Company is now working with a large clinical research
organization (CRO) that has started the key operational aspects of
the clinical study including site selection, site agreements, and
vendor agreements. The CRO has identified clinical sites for
participation in the COVID-19 clinical study.
- The Company is prepared to provide Tempol drug product for the
clinical study for distribution to the clinical sites as subjects
are enrolled.
- The Company is also engaged in activities intended to support
preparing an IND for a study of Tempol for the treatment of
Radiation Dermatitis. The manufacturer for the topical Tempol gel
has been identified and drug substance is available for
manufacturing.
- The Company is also investigating the utility of Tempol for the
treatment of cocaine and methamphetamine abuse. A number of
published studies in animals suggest that Tempol significantly
decreases the urge for both cocaine and methamphetamines and
cocaine abuse. Methamphetamine abuse is a significant unmet public
health problem that parallels the opioid epidemic. According to the
Centers for Disease Control (CDC), methamphetamine
use resurged in the United States from 2015 to 2018, rising to
an annual use rate of 59.7 per 1,000 adults, or approximately 14.7
million individuals per year.
Targeted Potential Milestones
- Acceptance of the NDA and receipt of a target action date for
ZIMHI
- Start of patient enrollment into a Phase 2/3 clinical trial of
Tempol in COVID-19 patients
- Increasing sales of SYMJEPI
- Approval and commercial launch of ZIMHI
- IND-enabling development of Tempol for additional
indications
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. (USC), 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. For additional information about Adamis
Pharmaceuticals, please visit www.adamispharmaceuticals.com.
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
beliefs or that 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 CRL relating to the
Company’s NDA for the ZIMHI product, whether the FDA will accept
the Company’s resubmitted NDA for review, and the timing and
outcome of the FDA’s review of the resubmitted NDA; the Company’s
ability to sustain the projected increase in unit sales of SYMJEPI;
the timing and outcome of any IND that the Company may submit for
the study of Tempol for the treatment of Radiation Dermatitis; the
Company’s beliefs concerning the results of any future studies or
clinical trials that the Company may conduct relating to Tempol,
ZIMHI or its other products or product candidates; the Company’s
beliefs concerning the anticipated timing of activities relating to
its Phase 2/3 clinical studies relating to Tempol; the Company’s
beliefs concerning anticipated commencement and completion dates
for clinical trials; the Company’s beliefs concerning its ability
to commercialize its 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 SYMJEPI, ZIMHI or its other products
and product candidates; statements about strategies, objectives and
the Company’s future goals and achievements; future financial
results of the Company and its subsidiaries; future development and
regulatory actions concerning the Company’s product candidates;
expectations and goals for future growth; guidance regarding future
periods; and other statements concerning the Company’s future
operations and activities. Statements in this press release
concerning future events depend on several factors beyond the
Company's control, including the absence of unexpected developments
or delays, market conditions, and the regulatory approval process,
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 regarding whether the FDA
will accept for review the Company’s resubmitted NDA relating to
ZIMHI or the timing or outcome of the FDA’s review of the
resubmitted NDA, or that the Company will be able to successfully
take any actions or develop any additional information that the FDA
may require in connection with its review of the resubmitted NDA
for ZIMHI. The FDA may require additional studies, or other
actions, data or information, relating to the ZIMHI NDA. There can
be no assurances that the FDA will consider the Company’s responses
to the matters raised in the ZIMHI CRL as satisfactory, concerning
the timing or costs of any additional actions that may be required
in connection with the resubmitted NDA, that the FDA will approve
the resubmitted NDA relating to the Company’s ZIMHI product, or
that the product will be able to compete successfully in the market
if approved and launched. The Company may not achieve one or more
of the target future milestones described in the press release
either within the anticipated time periods or at all. In addition,
forward-looking statements concerning the Company’s anticipated
future activities assume that the Company has sufficient funding to
support such activities and continue its operations and planned
activities. As discussed in the Company’s filings with the
Securities and Exchange Commission (SEC), the Company may require
additional funding, and there are no assurances that such funding
will be available if required. Failure to timely obtain required
funding would adversely affect the Company and could require it to
materially reduce or suspend operations or one or more clinical
trials or other product development activities, or delay or prevent
its ability to realize the results contemplated by such forward
looking statements. As previously disclosed, each of the Company
and USC recently received a subpoena from the U.S. Attorney’s
Office for the Southern District of New York issued in connection
with a criminal investigation. Accordingly, all forward-looking
statements are subject to the outcome of this investigation, as
well as the related investigation being conducted by the Company’s
Audit Committee. In addition, the Company cannot assess the impact
of each factor on its 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, the Company undertakes 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, including
its annual report on Form 10-K for the year ended December 31,
2020, and its 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.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorWestwicke
ICR 619.228.5886robert.uhl@westwicke.com
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