Adamis Pharmaceuticals Discusses 2017 Highlights and Business Update
15 Marzo 2018 - 3:59PM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided
investors with an update concerning certain accomplishments for
2017 and accomplishments and goals for 2018.
2017 Highlights
As reflected in the company’s annual report on Form 10-K for
year ending December 31, 2017, recently filed with the Securities
and Exchange Commission, some of the company’s accomplishments
during 2017 included the following:
- New Drug Application (“NDA”) for Symjepi TM (epinephrine)
Injection 0.3mg product, was approved by the U.S. Food and Drug
Administration (“FDA”) for the treatment of allergic reactions
(Type I) including anaphylaxis.
- Supplemental New Drug Application (“sNDA”) was submitted for
the lower dose Symjepi TM (epinephrine) Injection 0.15mg product
for patients weighing 33-65 pounds.
- Investigational New Drug (“IND”) application was submitted to
the FDA for a Naloxone injection product candidate, which uses the
same approved injection device, for the treatment of opioid
overdose.
- The number of outstanding warrants was reduced through exercise
transactions, which the company believes improved its balance
sheet.
- U.S. Compounding, Inc. subsidiary applied for a patent and
began marketing a novel equine ulcer product for which the company
believes there could be a significant market.
Early 2018 Highlights
Some of the company’s accomplishments during 2018 include the
following:
- In January, an IND application was submitted to the FDA for a
beclomethasone HFA (APC-1000) product candidate and in February,
the company received approval from the FDA to proceed with Phase 3
clinical studies.
- In February, Adamis received correspondence from the FDA
indicating that the agency had determined that the company’s sNDA
for Symjepi ™ (epinephrine) Injection 0.15mg was sufficiently
complete to permit a substantive review and indicated that no
potential review issues were identified as of the date of the
agency’s communication.
- In March, Adamis presented human factors data for Symjepi ™ at
the American Academy of Allergy Asthma and Immunology joint
congress with the World Allergy Organization, and another human
factors study was published in a peer-reviewed journal.
More on APC-1000
After the IND submission to the FDA, Adamis has recently
received approval by the FDA to proceed to pivotal Phase 3 studies
of APC-1000 in asthmatics. APC-1000 consists of a metered dose
inhaler device containing an HFA (hydrofluoroalkane) inhaled
corticosteroid called Beclomethasone, intended for the treatment of
asthma. An ideal inhaled corticosteroid provides adequate
lung exposure with limited systemic absorption of the drug.
APC-1000 is being developed with the goal of demonstrating efficacy
(lung function) and lower systemic absorption, thereby
differentiating it from the current market leading inhaled
corticosteroids. Following commencement of the studies, each
asthmatic patient will be enrolled in the study for twelve
weeks.
Asthma causes recurring periods of wheezing, chest tightness,
shortness of breath, and cough. Asthma affects people of all ages,
but it most often starts during childhood. In the United States,
more than an estimated 25 million people are known to have asthma.
Based on industry sources, we estimate that the annual global sales
of prescription steroid HFA and similar products are approximately
$3 billion, of which we intend to target a smaller niche.
Inhaled corticosteroids play a major role in reducing the
morbidity and mortality from asthma and also reduce the need for
oral corticosteroids and their related systemic toxicity risks.
According to the Expert Panel Report-3 on the Guidelines for the
Diagnosis and Management of Asthma, inhaled corticosteroids, such
as Beclomethasone, are recommended for all stages of persistent
asthma in adults and children. However, inhaled corticosteroids are
also known to have local and systemic adverse effects. The
goal of the Phase 3 study of APC-1000 is mainly to demonstrate
efficacy, but in addition, show an improved safety profile for
asthmatic patients.
Dr. Carlo, commenting on the Phase 3 clinical studies of
APC-1000, said, “We are pleased with the news of receiving approval
to proceed to pivotal Phase 3 studies of APC-1000 by the FDA. We
will continue to work with them and seek their guidance on the
commercialization of what we believe is a needed product.”
Dr. Ronald Moss, Chief Medical Officer of Adamis, added, “Our goal
is to initiate the Phase 3 studies as soon as reasonably possible,
during 2018. Having a cost-effective inhaled corticosteroid with a
good safety profile would, we believe, greatly benefit asthmatic
patients.”
Future Milestones
Some of the company’s goals for the 2018 year include the
following:
- Finalizing and announcing the commercialization strategy for
Symjepi ™ (epinephrine) Injection 0.3mg;
- FDA approval for Symjepi TM (epinephrine) Injection
0.15mg;
- Initiate pivotal Phase 3 studies of APC-1000 in
asthmatics;
- Complete a “proof of concept” study with dry powder inhaler
platform using fluticasone;
- Filing an NDA for Naloxone injection;
- Increase sales of compounded medications from our U.S.
Compounding, Inc. subsidiary by at least 30%.
Dr. Carlo continued, “We remain committed to bringing Symjepi TM
to market and are pleased with recent developments regarding our
discussions with potential commercialization partners since our
last press release pertaining to this topic. Once the
commercial strategy is finalized, our focus will be advancing our
other product candidates with the objective of increasing
shareholder value. The entire Adamis team is working hard to
achieve these goals during 2018.”
About Adamis PharmaceuticalsAdamis
Pharmaceuticals Corporation is a specialty biopharmaceutical
company focused on developing and commercializing products in the
therapeutic areas of respiratory disease and allergy. The company’s
first product, Symjepi™ (epinephrine) Injection 0.3mg, was approved
for use in the emergency treatment of acute allergic reactions,
including anaphylaxis. Adamis’ product pipeline includes HFA
metered dose inhaler and dry powder inhaler products for the
treatment of bronchospasm and asthma.
The Company’s U.S. Compounding, Inc. (USC) subsidiary, which is
registered as a drug compounding outsourcing facility under Section
503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug
Quality and Security Act, compounds sterile prescription drugs, and
certain nonsterile drugs for human and veterinary use, to patients,
physician clinics, hospitals, surgery centers and other clients
throughout most of the United States.
Adamis Forward Looking StatementsThis 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 timing and outcome of finalizing the
commercialization arrangements and strategy for its Symjepi ™
(epinephrine) Injection 0.3mg product; statements about strategies,
objectives and our future goals and achievements; the company’s
ability to commercialize its product and product candidates; 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; expectations and goals for future
growth; current or planned clinical trials or research and
development activities; anticipated commencement and completion
dates for clinical trials; product development timelines;
anticipated dates for commercial introduction of products; guidance
regarding future periods; 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
results of studies relating to Symjepi and user perceptions of
Symjepi; 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. In addition, many 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 to continue operations, and there are no
assurances that such funding will be available. Failure to
timely obtain required funding would adversely affect and could
delay or prevent our ability to realize the results contemplated by
such forward looking statements. 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. In addition, 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, 2017,
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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