Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA - Seite 2

About Adamis Pharmaceuticals

Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease, allergy and opioid overdose. The company’s SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Please refer to www.SYMJEPI.com for additional product information. Adamis is developing additional products, including a naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, and a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for use by hospitals, clinics and surgery centers throughout most of the United States.

Adamis 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 future results of operations, including, but not limited to the following matters: the timing or outcome of the FDA’s review of the company’s resubmitted NDA relating to its naloxone product candidate and whether the FDA will approve the resubmitted NDA; the company’s beliefs concerning its ability to commercialize the naloxone product candidate if approved and commercialized; the company’s beliefs concerning the size of the markets in which the product candidate will compete if approved; the company’s beliefs concerning the safety and effectiveness of its products and product candidates; the Company’s beliefs concerning its exclusive distribution and commercialization agreement with USWM, LLC for U.S. commercial rights for the ZIMHI product and whether milestone payments and net profit share payments will be made pursuant to that agreement; 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. 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. The timing and outcome of the FDA’s review of our NDA is uncertain. There is no assurance that the FDA will approve the NDA relating to our naloxone product candidate (or any other NDA that we file) or that other matters or events relating to the submission and regulatory review process under Section 505(b)(2) of the Food, Drug & Cosmetic Act will not differ from our expectations or result in delays in the regulatory approval process. There are no assurances that the FDA will regard our resubmitted NDA as satisfactorily responding to the matters raised in the earlier CRL or in our Type A meeting with the FDA in February 2020. The FDA could issue another CRL, require additional studies or information, or take other actions other than approval of our resubmitted NDA. Receipt of an additional CRL or other adverse action by the FDA concerning our NDA could result in significant additional time and expense before our ZIMHI NDA is approved, if approved at all, and marketing of ZIMHI could commence. There are no assurances concerning the amount of milestone payments or net profit share payments that we may receive in the future pursuant to our agreement with USWM. In addition, 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, and there are no assurances that such funding will be available if required. 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 our filings from time to time with the SEC, including our annual report on Form 10-K for the year ended December 31, 2019, and our subsequent filings 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.