ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP) Files An 8-K Other Events

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ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP) Files An 8-K Other Events

Item 8.01Other Events

On June 15, 2017, Adamis Pharmaceuticals Corporation (Adamis or
the Company) issued a press release announcing that the U.S. Food
Drug Administration (FDA) has approved the Companys Epinephrine
Injection USP, 1:1000 (0.3 mg Pre-filled single dose syringe)
(PFS) product for the emergency treatment of allergic reactions
(Type I) including anaphylaxis. The press release also announced
that the FDA approved the trade name of Symjepi for the product.
The approval was to the FDAs review of the Companys New Drug
Application (NDA), which was amended and resubmitted in December
2016, to the Food, Drug Cosmetic Act, as amended, relating to the
Epinephrine PFS product. Symjepi provides two single dose
syringes of epinephrine (adrenaline), which is used for
emergency, immediate administration in acute anaphylactic
reactions to insect stings or bites, allergic reaction to certain
foods, drugs and other allergens, as well as idiopathic or
exercise-induced anaphylaxis. In the press release, the Company
indicated that it was in the process of exploring
commercialization options and discussions with potential partners
regarding commercialization of the product, and that in the
interim, it expected to build inventory levels in preparation for
an anticipated launch in the second half of this year. The
Company also indicated in the press release that it was preparing
for the submission of a second NDA to the FDA for a junior, lower
dose version of the product.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements relate to
anticipated future events or future results of operations,
including, but not limited to, the following statements: the
companys beliefs concerning the timing and effectiveness of its
commercialization strategies; the companys beliefs concerning the
anticipated timing and nature of a commercial launch of its
Epinephrine PFS product; the ability of the Epinephrine PFS
product to compete successfully in the market; the companys
ability to build inventory levels of the product in anticipation
of a commercial launch; and the companys beliefs concerning the
timing and outcome of any future New Drug Application that the
company may submit to the FDA relating to a junior, lower dose
version of its Epinephrine PFS product. These statements are only
predictions and involve known and unknown risks, uncertainties
and other factors, which may cause the companys actual results to
be materially different from the results anticipated by these
forward-looking statements. Statements in this Report concerning
future events depend on several factors beyond the companys
control, including without limitation the following: adequate
funding to support the activities contemplated by the
forward-looking statements; the nature of any commercialization
arrangements that may be entered into or the nature of any
commercial launch of the product; the success of the Epinephrine
PFS product in the marketplace and the actions of competitors in
the marketplace; and the absence of unexpected regulatory
developments or delays. There can be no assurances regarding the
commercialization options that the company will pursue; that the
company will enter into any agreements with potential partners
regarding commercialization of the Epinephrine PFS product or
what the terms of any such agreement might be; that the companys
Epinephrine PFS product will be commercially launched by the end
of the year or what the nature of the launch may be; that the
product will be able to compete successfully in the market; that
the company will successfully build inventory levels in
anticipation of a product launch; regarding actions that
competitors may take in response to the FDAs approval of the
Epinephrine PFS product or any commercial launch of the product;
or concerning the timing of a submission to the FDA of an NDA
relating to a junior, lower dose version of the product or the
timing or outcome of the FDAs review of any such submission.
Factors that might cause actual results to differ from the
results anticipated by forward-looking statements made in this
Report include, without limitation: funding limitations regarding
anticipated activities; delays in entering into commercialization
arrangements with potential partners or delays in
commercialization of the Epinephrine PFS product; actions by
competitors in the marketplace or otherwise; and unexpected
adverse regulatory developments relating to the product or to the
companys anticipated NDA submission relating to a junior, lower
dose version of the product. Certain of the above matters, and
other 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 Report speak only as the date
of this Report, and Adamis expressly disclaims any obligation to
update any forward-looking statements.

Item 9.01Financial Statements and Exhibits

(d) Exhibits.

99.1Press release dated June 15, 2017.


About ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP)

Adamis Pharmaceuticals Corporation is a pharmaceutical company. The Company is engaged in the development of its specialty pharmaceutical products. The Company is developing various products in the allergy and respiratory markets, including a dry powder inhaler technology that it acquired from 3M Company (3M). The Company’s product portfolio includes specialty pharmaceutical products, such as Epinephrine pre-filled syringe (PFS), APC-5000 dry powder inhaler (DPI), APC-1000 and APC-2000, and biotechnology products, such as TeloB-VAX (vaccine), APC-100, APC-200 and APC-300. The Company’s lead product candidate, the Epinephrine Injection USP 1:1000 0.3 milligram Pre-filled Single Dose Syringe, or the Epinephrine PFS, is a pre-filled syringe designed to deliver a premeasured 0.3 milligrams dose of epinephrine for the treatment of anaphylaxis. The Company also has licensed vaccine technology called somatic transgene immunization (STI) technology.

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