Adamis Pharmaceuticals Strengthens Patent Portfolio for Its Naloxone Product Candidate
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced that a patent application for its ZIMHI™ high-dose naloxone injection has been approved by the U.S. Patent and Trademark Office. This patent covers a composition with a dose equal to or greater than five milligrams for injection use, aimed at addressing the opioid overdose crisis, which has seen record fatalities, especially amid the COVID-19 pandemic. The company believes this patent enhances its existing intellectual property for ZIMHI, which is under FDA review.
- Patent approval strengthens intellectual property for ZIMHI, providing competitive protection.
- ZIMHI's 5 mg dosage shows higher efficacy in reversing opioid toxicity compared to existing products.
- The growing opioid crisis increases demand for effective overdose treatments like ZIMHI.
- FDA's complete response letter raises uncertainties about ZIMHI's approval timeline.
- Potential need for additional studies as indicated by the FDA, which may delay product launch.
SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company") today announced that it recently received a notice that one of its patent applications relating to its ZIMHI™ high dose naloxone injection product candidate, intended for the treatment of opioid overdose, was allowed by the U.S. Patent and Trademark Office. The allowed claims describe a naloxone composition at a dose greater than or equal to five milligrams configured for administration as an injection. The company believes this patent should protect and strengthen the existing intellectual property associated with the product candidate.
According to new data from the U.S. Centers for Disease Control and Prevention (“CDC”), deaths from drugs overdoses have substantially accelerated amid the COVID-19 pandemic. The CDC data indicates that more than 81,000 drug overdose fatalities occurred in the U.S. between June 2019 and May 2020. This is the highest number of overdose deaths ever recorded in a year-long period. These numbers are expected to increase.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, added, “The current opioid epidemic seems to be fueled by the more potent synthetic opioids such as fentanyl and its derivatives, and it has worsened during the COVID-19 pandemic. Concomitant with the rise of overdoses caused by synthetic opioids, deaths have risen despite increased availability of the current naloxone product. Administratively, too little too late can be life-threatening. The CDC has noted the need for multiple doses of the current nasal naloxone product, which suggests that a higher dose product may be necessary for the successful resuscitation of overdose victims. Additionally, there is concern that administering the nasal product could potentially put caregivers at risk of contracting COVID-19.
“Our 5 mg dose of naloxone delivered by intramuscular or subcutaneous injection has demonstrated significantly higher availability (naloxone in the blood) at 2.5 and 5 minutes (critical period) when compared to the current FDA-approved product. This should translate into more successful reversal of toxicity caused by higher potency synthetic opioids and potentially save many lives. We look forward to meeting with the FDA to discuss the responses that we have submitted to the agency to the issues raised in the most recent complete response letter relating to our New Drug Application for ZIMHI, and will continue to work with the FDA towards our goal to get ZIMHI approved.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The company’s SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis’ naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company’s subsidiary, US Compounding Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, surgery centers, and vet clinics throughout most of the United States.
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 or future financial performance, including, but not limited to the following statements: the extent of intellectual property protection that may be afforded by any issued patents or patent applications relating to ZIMHI product or the company’s other products and product candidates; the severity of, and reasons for, the current opioid crisis; the company’s beliefs concerning the safety or effectiveness of its ZIMHI product; the company’s beliefs concerning the ability of its ZIMHI product to reverse toxicity caused by higher potency synthetic opioids and potentially save lives; the company's beliefs concerning the ability of its product candidates to compete successfully in the market; the company’s beliefs concerning its ability to satisfactorily respond to the matters raised in the FDA’s complete response letter (“CRL”); the company’s beliefs concerning the information, data and actions that the FDA may require in connection with responding to the most recent CRL relating to ZIMHI or resubmitting the company’s New Drug Application (NDA) relating to ZIMHI; the company’s beliefs concerning the timing and outcome of any meeting with the FDA or appeal and formal dispute resolution process that the company may initiate; the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s NDA relating to the ZIMHI product or any resubmitted NDA; and the results of any future clinical trials that the company may conduct relating to ZIMHI. 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. The FDA may require additional studies, or other actions, data or information, prior to any resubmission of the NDA. There can be no assurances that the company will be able to satisfactorily respond to the matters raised in the FDA’s CRL or concerning the timing of any resubmission by us of the NDA responding to the CRL, concerning the timing or costs of any additional actions that may be required in connection with any resubmission of the NDA, that the FDA will approve any resubmitted NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, that the company will be successful in any formal dispute resolution appeal process with the FDA, or that the product will be able to compete successfully in the market if approved and launched. 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. The company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
Contact Adamis
Mark Flather
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation
(858) 412-7951
mflather@adamispharma.com
FAQ
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