Current Report Filing (8-k)
June 16 2017 - 6:04AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): June 15, 2017
ADAMIS PHARMACEUTICALS CORPORATION
(Exact Name of Registrant as Specified
in Charter)
Delaware
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0-26372
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82-0429727
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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11681
El Camino Real, Suite 300
San
Diego, CA
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92130
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s telephone number,
including area code: (858) 997-2400
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other
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 Company’s 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 pursuant to the FDA’s review of the Company’s New
Drug Application (“NDA”), which was amended and resubmitted in December 2016, pursuant 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 company’s beliefs concerning the timing and effectiveness of its
commercialization strategies; the company’s 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 company’s ability to build inventory levels of the product in anticipation of a commercial launch; and
the company’s 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 company’s 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 company’s 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 company’s 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 FDA’s 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 FDA’s 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 company’s 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 9.01 Financial
Statements and Exhibits
(d) Exhibits.
99.1
Press release dated June 15, 2017.
SIGNATURE
Pursuant to
the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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ADAMIS PHARMACEUTICALS CORPORATION
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Dated: June
15, 2017
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By:
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/s/ Robert O. Hopkins
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Name: Robert O. Hopkins
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Title: Chief Financial Officer
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