“The bulk of our focus during the first quarter was on preparing for the Type-A meeting with the FDA regarding our New Drug Application for ZIMHI naloxone injection product intended for the treatment of opioid overdose. Based on feedback received in that meeting, we resubmitted the NDA in May,” stated
Product and Pipeline Updates and Other Corporate Developments
SYMJEPI® (epinephrine) Injection
- Since completing the transition of SYMJEPI from Sandoz in the fourth quarter of 2020, Adamis’ new commercial partner,
US WorldMeds, continues to make gains in the epinephrine market.
- In January, both SYMJEPI products became available through the
Walgreens Prescription Savings Clubat a discounted price of $99.99per two-pack.
- Based on third-party market data, the Company believes SYMJEPI unit sales have increased approximately 90% for the five months from
December 2020through April 2021compared to the same five-month period of the prior year, since transitioning the product from Sandoz.
- Adamis expects the Walgreens arrangement, along with other commercial initiatives currently underway, will continue the positive trend on sales of SYMJEPI products for the remainder of 2021.
ZIMHI (naloxone) Injection
- During the first quarter 2021, Adamis submitted responses to the FDA to address the deficiencies identified in the complete response letter (CRL) relating to the Company’s ZIMHI New Drug Application (NDA), along with a request for a Type-A meeting with the agency.
- The Company met with the FDA in April to discuss the responses and the regulatory path forward for ZIMHI.
- Based on the discussions and feedback from the agency, Adamis resubmitted its NDA for ZIMHI to the FDA in May and is currently awaiting an agency response and a new action date.
- In February, the Company’s Investigational New Drug Application (IND) relating to a protocol for a clinical trial of Tempol in COVID-19 patients received FDA clearance to begin clinical testing.
- The Company is now working with a large clinical research organization (CRO) that has started the key operational aspects of the clinical study including site selection, site agreements, and vendor agreements. The CRO has identified clinical sites for participation in the COVID-19 clinical study.
- The Company is prepared to provide Tempol drug product for the clinical study for distribution to the clinical sites as subjects are enrolled.
- The Company is also engaged in activities intended to support preparing an IND for a study of Tempol for the treatment of Radiation Dermatitis. The manufacturer for the topical Tempol gel has been identified and drug substance is available for manufacturing.
- The Company is also investigating the utility of Tempol for the treatment of cocaine and methamphetamine abuse. A number of published studies in animals suggest that Tempol significantly decreases the urge for both cocaine and methamphetamines and cocaine abuse. Methamphetamine abuse is a significant unmet public health problem that parallels the opioid epidemic. According to the
Centers for Disease Control( CDC), methamphetamine use resurged in the United Statesfrom 2015 to 2018, rising to an annual use rate of 59.7 per 1,000 adults, or approximately 14.7 million individuals per year.
Targeted Potential Milestones
- Acceptance of the NDA and receipt of a target action date for ZIMHI
- Start of patient enrollment into a Phase 2/3 clinical trial of Tempol in COVID-19 patients
- Increasing sales of SYMJEPI
- Approval and commercial launch of ZIMHI
- IND-enabling development of Tempol for additional indications
Adamis Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or beliefs or that otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the Company’s beliefs concerning its ability to satisfactorily respond to the matters raised in the FDA’s CRL relating to the Company’s NDA for the ZIMHI product, whether the FDA will accept the Company’s resubmitted NDA for review, and the timing and outcome of the FDA’s review of the resubmitted NDA; the Company’s ability to sustain the projected increase in unit sales of SYMJEPI; the timing and outcome of any IND that the Company may submit for the study of Tempol for the treatment of Radiation Dermatitis; the Company’s beliefs concerning the results of any future studies or clinical trials that the Company may conduct relating to Tempol, ZIMHI or its other products or product candidates; the Company’s beliefs concerning the anticipated timing of activities relating to its Phase 2/3 clinical studies relating to Tempol; the Company’s beliefs concerning anticipated commencement and completion dates for clinical trials; the Company’s beliefs concerning its ability to commercialize its products and product candidates; 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 SYMJEPI, ZIMHI or its other products and product candidates; statements about strategies, objectives and the Company’s future goals and achievements; future financial results of the Company and its subsidiaries; future development and regulatory actions concerning the Company’s product candidates; expectations and goals for future growth; guidance regarding future periods; and other statements concerning the Company’s future operations and activities. Statements in this press release concerning future events depend on several factors beyond the Company's control, including the absence of unexpected developments or delays, market conditions, and the regulatory approval process, 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 regarding whether the FDA will accept for review the Company’s resubmitted NDA relating to ZIMHI or the timing or outcome of the FDA’s review of the resubmitted NDA, or that the Company will be able to successfully take any actions or develop any additional information that the FDA may require in connection with its review of the resubmitted NDA for ZIMHI. The FDA may require additional studies, or other actions, data or information, relating to the ZIMHI NDA. There can be no assurances that the FDA will consider the Company’s responses to the matters raised in the ZIMHI CRL as satisfactory, concerning the timing or costs of any additional actions that may be required in connection with the resubmitted NDA, that the FDA will approve the resubmitted NDA relating to the Company’s ZIMHI product, or that the product will be able to compete successfully in the market if approved and launched. The Company may not achieve one or more of the target future milestones described in the press release either within the anticipated time periods or at all. In addition, forward-looking statements concerning the Company’s anticipated future activities assume that the Company has sufficient funding to support such activities and continue its operations and planned activities. As discussed in the Company’s filings with the
Adamis Investor Relations
Source: Adamis Pharmaceuticals Corporation