0001564590-15-002073.txt : 20150330 0001564590-15-002073.hdr.sgml : 20150330 20150327201122 ACCESSION NUMBER: 0001564590-15-002073 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150327 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150330 DATE AS OF CHANGE: 20150327 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adamis Pharmaceuticals Corp CENTRAL INDEX KEY: 0000887247 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820429727 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36242 FILM NUMBER: 15732263 BUSINESS ADDRESS: STREET 1: 11455 EL CAMINO REAL STREET 2: SUITE 310 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: (858) 997-2400 MAIL ADDRESS: STREET 1: 11455 EL CAMINO REAL STREET 2: SUITE 310 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: CELLEGY PHARMACEUTICALS INC DATE OF NAME CHANGE: 19950615 8-K 1 admp-8k_20150327.htm 8-K

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): March 27, 2015

ADAMIS PHARMACEUTICALS CORPORATION

(Exact Name of Registrant as Specified in Charter)

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):

o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a‑12)

o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d‑2(b))

o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e‑4(c))

Item 8.01Other Events

On March 27, 2015, Adamis Pharmaceuticals Corporation (“Adamis” or the “Company”) issued a press release announcing that it had received a Complete Response Letter (“CRL”) from the U.S. Food & Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for its Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe, or the Epinephrine PFS, product, for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. On May 28, 2014, we submitted an NDA to the FDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for approval of the Epinephrine PFS product. The Epinephrine PFS delivers a premeasured dose of ephinephrine for the emergency treatment of anaphylaxis.

A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.

The questions raised by the FDA in the CRL pertained to Chemistry, Manufacturing and Controls (“CMC”) relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the NDA will remain open until the CMC issues are resolved. The letter indicated that the agency had reserved comment, if any, on the proposed labeling for the product until the application was otherwise adequate.

The Company is reviewing the CRL and plans to request a meeting with the FDA to discuss the CRL, including clarifying the product delivery volume specifications that will be required. In light of the above matters, the Company does not expect to be in a position to commence commercial sales of the Epinephrine PFS product by the end of the second quarter of 2015.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

99.1Press release dated March 27, 2015.

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: March 27, 2015	By:	/s/ Robert O. Hopkins
	Name:	Robert O. Hopkins
	Title:	Chief Financial Officer

EX-99.1 2 admp-ex991_201503276.htm EX-99.1

Exhibit 99.1

Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA

SAN DIEGO, CA--(March 27, 2015) - Adamis Pharmaceuticals Corporation

(NASDAQ: ADMP) (“Company”) announced that today it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product, for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. On May 28, 2014, Adamis submitted an NDA to the FDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for approval of the Epinephrine PFS product.

A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form. The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC) relating to the volume of dose delivered by the syringe, including our ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolved.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications. Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market.”

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, allergy, oncology and immunology. 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-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. The company's vaccine product candidates and cancer drug product candidates include TeloB-VAX, a cell-based therapeutic cancer vaccine and three drugs, APC-100, APC-200, and APC-300, for the treatment of prostate cancer.

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 CRL 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. 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
Director, Investor Relations

& Corporate Communications
(858) 412-7951
mflather@adamispharma.com

Mark Gundy
External Investor Relations
972-240-1873
markgundy@gmail.com

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

11682 El Camino Real, Suite 300

San Diego, CA

(Address of Principal Executive Offices)

(Zip Code)