SAN DIEGO, Feb. 26, 2019 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its sublingual tadalafil product. As previously announced, on December 28th, 2018, Adamis submitted an NDA for fast-disintegrating sublingual tadalafil (APC-8000) with the FDA for the treatment of erectile dysfunction (ED).
Upon its preliminary review, the FDA determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that Adamis supplement and include in a resubmitted NDA (i) longer real-time (versus accelerated) stability data and (ii) additional dissolution data for both the clinical and registration batches. Adamis may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter with the agency and seek additional guidance concerning information, data and specific deliverables that the agency would require for a resubmitted NDA to be deemed complete.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are obviously very disappointed with this development and are evaluating the letter and what the FDA has requested. We intend to work closely with the FDA to try to clearly map the path forward.”
Tadalafil is a drug used for treating erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia (BPH). Tadalafil is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors which includes, among others, sildenafil and vardenafil. Tadalafil is the drug in Lilly’s Cialis®, sildenafil is the drug in Viagra® (Pfizer) and vardenafil is the drug in Levitra® (GlaxoSmithKline). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED.
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 and allergy. The company’s Symjepi (epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection 0.15 mg products were approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis previously announced a distribution and commercialization agreement with Sandoz, a division of Novartis Group, to market Symjepi in the U.S. Adamis is developing additional products, including a sublingual tadalafil product candidate for the treatment of erectile dysfunction, a naloxone injection product candidate 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 human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients 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, future results of operations, or future risks and uncertainties, including, but not limited to the following matters: the company’s intention to request a Type A meeting with the FDA to discuss the refusal to file letter and the timing, occurrence and outcome of any such meeting with the FDA; what additional supporting data, information, studies or trials will be required or sufficient before the FDA will accept an NDA filing for the company’s tadalafil product candidate; whether any such required clinical trials or studies will be successful; whether any subsequent studies or data will demonstrate clinical superiority to existing products; whether any future clinical trials for the tadalafil product candidate will be completed on time or at all; potential changes in cost, scope and duration of the clinical development program relating to the tadalafil product candidate; whether the company will resubmit its New Drug Application for its tadalafil product candidate; risks that the tadalafil NDA is not accepted for filing by the FDA; the timing of any future FDA review and acceptance of a resubmitted NDA; the timing or ultimate outcome of the FDA’s review of the company’s NDA relating to its tadalafil tablet product candidate; if approved, whether the company’s tadalafil product candidate will be commercialized successfully; the company’s ability to advance its development-stage product candidates, including the tadalafil product candidate; 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. There is no assurance that the FDA will accept our NDA or a resubmitted NDA relating to our tadalafil tablet product candidate 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. 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 may 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, 2017, 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.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation