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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): December 16, 2016
ADAMIS PHARMACEUTICALS CORPORATION
(Exact Name of Registrant as Specified in Charter)
Delaware
(State or other jurisdiction
of incorporation)
0-26372
(Commission File Number)
11682 El Camino Real, Suite 300
San Diego, CA
(Address of Principal Executive Offices)
82-0429727
(IRS Employer
Identification No.)
92130
(Zip Code)
Registrant’s telephone number, including area code: (858) 997-2400
(Former name or Former Address, if Changed Since Last Report.)
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):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01
Other Events
On December 16, 2016, Adamis Pharmaceuticals Corporation (“Adamis” or the “Company”) issued a press release announcing
that the Company has resubmitted to the U.S. Food & Drug Administration (“FDA”) the Company’s New Drug Application (“NDA”)
pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for the Company’s Epinephrine Injection USP 1:1000
0.3mg Pre-filled Single Dose Syringe product candidate, for the emergency treatment of anaphylaxis. The resubmission is intended to
address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”).
A copy of the Company’s press release relating to the resubmission is filed as an exhibit to this Form 8-K.
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 future events or our future results of operations, including, but not limited to the
following statements: the Company’s beliefs concerning the timing and outcome of the FDA’s review of the Company’s NDA relating
to its Epinephrine PFS product candidate and the Company’s ability to satisfactorily respond to the matters raised in the FDA’s
Complete Response Letter relating to the Epinephrine PFS product; the Company's beliefs concerning the ability of the Epinephrine
PFS product or other product candidates to compete successfully in the market; the Company's beliefs concerning the safety and
effectiveness of its product candidates; the results of any future clinical trials that the Company may conduct relating to the
Epinephrine PFS product or the Company’s other product candidates; the costs of any additional studies or resubmissions to the FDA;
the ability to fund future product development; future revenues expected from any of its product candidates, assuming that they are
developed and approved for marketing by the FDA and other regulatory authorities; and the intellectual property protection that may
be afforded by any patents or patent applications relating to its products and product candidates. Statements in this Report concerning
future events depend on several factors beyond the company's control, including receipt of adequate funding to support these
activities, the absence of unexpected developments or delays, market conditions, and the regulatory approval process. 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 these forward-looking statements. There can be no assurances that the
Company will successfully complete development of the Epinephrine PFS product candidate, that the FDA will approve the NDA
following resubmission of the NDA by the Company, or that the product will be commercially successful if introduced. The
Company will require additional funding to commercially launch the product. Certain of these risks, uncertainties, and other factors
are described in greater detail in the Company’s filings from time to time with the SEC, which the Company 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, the Company expressly disclaims any obligation to update any forward-looking statements.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1
Press release dated December 16, 2016.
SIGNATURES
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.
ADAMIS PHARMACEUTICALS CORPORATION
Dated: December 23, 2016
By:
Name:
Title:
/s/ Robert O. Hopkins
Robert O. Hopkins
Chief Financial Officer
Adamis Pharmaceuticals Corporation 8-K
Exhibit 99.1
Adamis Pharmaceuticals Announces NDA Resubmission of Its
Epinephrine Pre-Filled Syringe Application to the FDA
SAN DIEGO, CA--(December 16, 2016)- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Company” or “Adamis”)
today announced the resubmission of the Company’s New Drug Application (“NDA”) to the U.S. Food and Drug Administration
(“FDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. The
resubmission is intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”).
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are pleased to resubmit our Epinephrine Pre-filled Syringe NDA.
With all of the recent news regarding products in the anaphylaxis market, we believe our product, now so, more than ever, can be a
part of the potential solution for patients and payors as there is an obvious need for a low-cost therapeutic alternative like our PFS. I
was encouraged by the results of the Human Factors study in that it showed our product to be intuitive in its use. In addition, based on
what we have seen, we believe that many individuals would prefer our product over the EpiPen. The Human Factors study consisted
of testing in trained and untrained adolescents (12 to 18 years of age), trained and untrained adults, and trained and untrained
caretakers.”
About Adamis Pharmaceuticals Corporation
Adamis 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 current specialty pharmaceutical product candidates
include the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000
for the treatment of asthma and chronic obstructive pulmonary disease, and APC-2000 for the treatment of bronchospasms. The
Company’s U.S. Compounding, Inc. 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, provides prescription compounded medications,
including compounded sterile preparations and non-sterile compounds, to patients, physician clinics, hospitals, surgery centers and
other clients throughout most of the United States. USC’s product offerings broadly include, among others, corticosteroids, hormone
replacement therapies, hospital outsourcing products, injectables, urological preparations, ophthalmic preparations, topical compounds
for pain and men’s and women’s health products.
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 our future results of operations, including, but not limited to the following statements: the
Company’s beliefs concerning the timing and outcome of the FDA’s review of the Company’s NDA relating to its Epinephrine PFS
product candidate and the company’s ability to satisfactorily respond to the matters raised in the FDA’s Complete Response Letter
relating to the Epinephrine PFS product; 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 its product candidates; the results of any future clinical
trials that the company may conduct relating to its product candidates; the ability to fund future product development; future revenues
expected from any of its product candidates, assuming that they are developed and approved for marketing by the FDA and other
regulatory authorities; and the intellectual property protection that may be afforded by any patents or patent applications relating to its
products and product candidates. Statements in this press release concerning future events depend on several factors beyond the
company's control, including receipt of adequate funding to support these activities, the absence of unexpected developments or
delays, market conditions, and the regulatory approval process. These statements 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 that the Company will successfully complete development of the PFS product
candidate, that the FDA will approve the NDA following resubmission of the NDA by the Company, or that the product will be
commercially successful if introduced. The Company will require additional funding to commercially launch the product. Certain of
these 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, Adamis expressly disclaims any obligation to update any forward-looking statements.
Contact Adamis
Mark Flather
Senior Director, Investor Relations
& Corporate Communications
(858) 412-7951
[email protected]