ADMP Adamis Pharmaceuticals Corporation

0.54
-0.02  -4%
Previous Close 0.56
Open 0.57
52 Week Low 0.27
52 Week High 1.57
Market Cap $39,815,436
Shares 73,732,288
Float 72,914,711
Enterprise Value $34,930,273
Volume 575,755
Av. Daily Volume 1,935,956
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Upcoming Catalysts

Drug Stage Catalyst Date
ZIMHI (naloxone HCI Injection)
Opioid overdose
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
APC-1000
Asthma/COPD
Phase 2
Phase 2
Phase 3 development on hold - noted May 9, 2019.
APC-8000 (sublingual tadalafil)
Erectile dysfunction
NDA Filing
NDA Filing
Refusal to file letter received February 26, 2019.
Symjepi - low dose
Anaphylaxis
Approved
Approved
FDA Approval announced September 27, 2018.
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
Approved
CRL issued March 27 2015. CRL issued again June 6, 2016. Approval announced June 15, 2017 following third submission.

Latest News

  1. SAN DIEGO, July 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that, on July 1, 2020, USWM, LLC ("USWM" or "US WorldMeds") began promoting Adamis' SYMJEPI ® (epinephrine) Injection 0.3mg and SYMJEPI ® (epinephrine) Injection 0.15mg products through its field sales force. As contemplated by the previously announced termination agreement between Adamis and Sandoz Inc., and the previously announced exclusive distribution and commercialization agreement between Adamis and USWM, USWM has been actively promoting SYMJEPI while preparing to launch through its field sales force. Adamis has also entered into a transition services agreement with Sandoz and USWM, which is intended to minimize any potential…

    SAN DIEGO, July 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that, on July 1, 2020, USWM, LLC ("USWM" or "US WorldMeds") began promoting Adamis' SYMJEPI ® (epinephrine) Injection 0.3mg and SYMJEPI ® (epinephrine) Injection 0.15mg products through its field sales force. As contemplated by the previously announced termination agreement between Adamis and Sandoz Inc., and the previously announced exclusive distribution and commercialization agreement between Adamis and USWM, USWM has been actively promoting SYMJEPI while preparing to launch through its field sales force. Adamis has also entered into a transition services agreement with Sandoz and USWM, which is intended to minimize any potential impact to patients and customers during the transfer of commercial rights regarding the SYMJEPI products from Sandoz to US WorldMeds.

    Dr. Dennis J. Carlo, President and CEO of Adamis, said, "We are very excited that US WorldMeds is now actively promoting both SYMJEPI products. Adamis has always believed that sales reps calling on high-prescribing allergists and primary care physicians was key to the success of SYMJEPI. I am very pleased those efforts are underway and I believe the US WorldMeds commercial infrastructure, combined with their expertise in acquiring and turning around underperforming assets from larger pharmaceuticals companies, bodes well for finally realizing the value of SYMJEPI in the market."

    P. Breckinridge Jones, Sr., CEO of US WorldMeds, added, "We have great expectations for SYMJEPI, and we plan to commit significant sales and marketing resources to leverage our commercial effort. SYMJEPI provides a unique alternative in the established epinephrine market, one which we believe will benefit from our enhanced focus. US WorldMeds is working closely with Sandoz to minimize market disruption while we increase our commercial and distribution efforts. We expect to complete the full transition from Sandoz during the third quarter of 2020."

    About the SYMJEPI Products

    SYMJEPI ® (epinephrine) Injection 0.3mg and SYMJEPI ® (epinephrine) Injection 0.15mg products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. In July 2018, Adamis licensed commercial rights for the U.S. to Sandoz Inc. On May 11, 2020, Adamis announced it was reacquiring commercial rights from Sandoz and entering into an exclusive distribution and commercialization agreement with US WorldMeds. Please refer to www.SYMJEPI.com for additional product information.

    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. 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.

    About US WorldMeds

    US WorldMeds is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. US WorldMeds has built a branded product portfolio in the therapeutic areas of addiction medicine, malignant hyperthermia, and central nervous system (CNS). In May 2020, the company acquired commercial rights to Adamis' SYMJEPI products in the U.S. market. On June 9, 2020, US WorldMeds completed the sale of its CNS division to Supernus Pharmaceuticals, Inc. More information on US WorldMeds can be found at USWorldMeds.com.

    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 future development and/or 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 outcome of transition services to be provided by Sandoz pursuant to the transition services agreement; the success of commercialization efforts by US WorldMeds regarding the SYMJEPI products; 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. 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, 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.

    Contact Adamis:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    (858) 412-7951

    Primary Logo

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  2. SAN DIEGO, June 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the publication of an article entitled "Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level" in the peer reviewed publication "PLOS ONE, " This study was done in collaboration with Rosa and Co.

    Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone works by reversing the detrimental effects of the opioid, including slowed breathing, brain dysfunction, loss of consciousness and death. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. Rapid resuscitation of an opioid overdose…

    SAN DIEGO, June 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the publication of an article entitled "Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level" in the peer reviewed publication "PLOS ONE, " This study was done in collaboration with Rosa and Co.

    Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone works by reversing the detrimental effects of the opioid, including slowed breathing, brain dysfunction, loss of consciousness and death. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. Rapid resuscitation of an opioid overdose with naloxone, an opioid antagonist, is critical as opioid induced toxicity results in rapid death, i.e., delaying adequate resuscitation can result in death.  Accordingly, the current approved naloxone doses (2 mg intramuscular (IM) and 4 mg intranasal (IN)), since they both give similar systemic exposure levels, might very well not be sufficient to reverse high doses of fentanyl. Fentanyl, a synthetic opioid, is considered 50 to 100 times more potent than morphine. According to the CDC, powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses.  To this end, it was recently reported that drug overdoses in British Columbia last month killed more people there than COVID-19 has all year.  The vast majority of the overdose deaths involved fentanyl.  There is no reason to believe that this same trend is not happening in the U.S.

    The manuscript describes an opioid receptor quantitative systems pharmacology (QSP) model which was developed to predict the effects of different IM doses of naloxone ( 2 mg, 5 mg, and 10 mg) in response to different levels of fentanyl exposure (low, medium, and high). The model defined a successful reversal as lowering the amount of opioid bound to the brain receptors to less than 50% within 10 minutes. For the lowest and middle levels of fentanyl exposure, the model predicted that the 2 mg IM naloxone resulted in successful resuscitations within ten minutes, but more rapid reversal was observed with the 5 and 10 mg doses. However, at the highest level of naloxone exposure, the model predicted that the 2 mg IM (and 4 mg IN) doses of naloxone did not result in a successful reversal. In contrast, the 5 and 10 mg doses of naloxone successfully reversed opioid toxicity.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "These results suggest that the current marketed doses of naloxone (2 mg IM or 4 mg IN) may be inadequate for rapid reversal of toxicity due to fentanyl exposure and that increasing the dose of naloxone is likely to improve outcomes. Therefore, it is reasonable to conclude that our high dose (5 mg IM) naloxone product candidate (ZIMHI) has the potential to improve outcomes and save lives."  

    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.  On May 11th the Company announced a partnership with US WOLRD MEDS for the commercialization of ZIMHI and SYMJEPI. The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs for human and veterinary use, 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.  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 relate to future events or 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 New Drug Application (NDA) relating to its ZIMHI™ (naloxone) Injection product candidate; the data and interpretation of the data from the company's studies pertaining to the ZIMHI product candidate; the company's ability to  commercialize its product and product candidates, itself or through commercialization partners; the company's beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company's beliefs concerning the safety and effectiveness of ZIMHI and its other products and product candidates; 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 can be no assurances regarding the timing or the outcome of the FDA's review process concerning the company's NDA relating to ZIMHI.  There can be no assurances that the FDA will agree with our interpretation of study data, will approve our NDA relating to our naloxone product candidate or will give final approval to our proposed brand name for the product, concerning the timing of any such approval, that the product will be commercially successful if approved and introduced, or concerning the outcome of any discussions with third parties concerning commercialization of the product.  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 Adamis' filings from time to time with the SEC, including its 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.

    Contacts:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951

     

    Primary Logo

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  3. SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today a license  to commercialize Tempol, a novel patented investigational drug for the treatment of Coronavirus (COVID-19).  The license includes the worldwide use of Tempol for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.  In addition, the exclusive license includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer.  A phase 2 radiation dermatitis clinical study has already been successfully completed, as well as discussions with FDA regarding the design of a pivotal phase 3 study. The license was obtained from Matrix…

    SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today a license  to commercialize Tempol, a novel patented investigational drug for the treatment of Coronavirus (COVID-19).  The license includes the worldwide use of Tempol for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.  In addition, the exclusive license includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer.  A phase 2 radiation dermatitis clinical study has already been successfully completed, as well as discussions with FDA regarding the design of a pivotal phase 3 study. The license was obtained from Matrix Biomed. 

    In consideration for Matrix providing the exclusive rights under its patent rights and related know-how relating to Tempol within the licensed fields, Adamis paid Matrix $250,000 following signing of the definitive agreement.  Adamis will also issue to Matrix 1,000,000 shares of Adamis convertible preferred stock, which will be convertible into an equal number of shares of common stock after and contingent on an increase in the number of available authorized shares of common stock under the company's restated certificate of incorporation.  Under the agreement, if any products are commercialized, net profits will be equally distributed between the parties.



    Coronavirus disease [Novel Coronavirus Disease (COVID-19), a human betacoronavirus] represents a global health problem.  Just within the U.S., the American Hospital Association estimates that the financial impact in losses for America's hospital and health care systems could exceed 200 billion dollars by mid-2020.  Therefore, identification of new drugs and biologics for treating COVID-19 infection is urgently needed.  Most common symptoms at onset include fever, cough, sore throat, sneezing, rhinorrhoea (runny nose) and fatigue.  In severe cases, this can progress to pneumonia, acute respiratory distress syndrome (ARDS), acute cardiac injury and eventually death.  ARDS occurs when there is damage to the lungs resulting in fluid accumulation in the small air sacs of the lungs.  This fluid causes a decrease in the oxygen supply to vital organs which can eventually lead to death.



    Tempol has demonstrated anti-inflammatory, anticogulant,  and antioxidant activity.  Tempol specifically targets ARDS, which is the major cause of death of COVID-19.  Both inflammatory cytokines and reactive oxygent species (ROS) generated from cells of the immune system (macrophages and neutrophils) damage the lungs in ARDS patients.  In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm) such as TNF-α, IL-Iβ, IL-6, IL-10, NF-kβ, ICAM-1, HIF-1a, HIF-2a and others. In addition, Tempol works as an antioxidant and decreases the harmful effects of ROS. ROS is a type of unstable molecule that contains oxygen and easily reacts with other molecules in the cell.  It can cause damage to all macromolecules, i.e., lipids, DNA, RNA and proteins.  In addition, Tempol has also been shown to decrease platelet aggregation and clotting, a problem observed in many COVID-19 patients. Published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury.  Additional published studies, in which animals were infected with betacoronavirus, show that Tempol treatment resulted in increased survival and decreased viral load. Taken together, this scientific data argue for the use of Tempol in preventing and treating the most severe death related lung manifestation of COVID-19.  Tempol has already been shown to be safe in multiple human clinical studies. 



    Dr. Dennis J. Carlo, President and CEO of Adamis commented: "We are hopeful that Tempol can be part of the solution to the current pandemic.  We believe that Tempol's multiple modes of action such as an antioxidant, an anticoagulant, and an anti-inflammatory may be more beneficial than targeting a single pathological pathway. Tempol has been the focus of numerous peer reviewed published articles by highly respected scientists from various institutions such as: Radiation Biology Branch of the National Cancer Institute, National Institute of Health, FDA Center for Drug Evaluation and Research, Georgetown University, University of Pittsburgh, University of Pennsylvania, Weizmann Institute, Johns Hopkins University, University of California San Diego, University of Texas and many more.  Tempol has been shown to be involved in cellular metabolism, apoptosis, (form of programmed cell death or cellular suicide), cell growth and development, stress response, inflammation, and angiogenesis.  Its role in decreasing multiple pro-inflammatory cytokines and controlling both the overactive inflammatory response and the cytokine storm could lead to one treatment strategy that helps decrease the burden to our health care system by reducing hospitalizations and potentially saving the many lives of those infected with COVID-19."



    Dr. Ronald Moss, Chief Medical Office at Adamis, stated "The previously published studies of Tempol provide a reasonable scientific rationale to begin immediate clinical testing against COVID-19 during this pandemic.  We plan on leveraging our depth of clinical experience with respiratory viruses and government collaborations to focus on this urgent public health problem.  To this end, Adamis will apply for government and other forms of funding to conduct well designed clinical trials and will work closely with FDA to expedite the testing.  Our goal is to test Tempol against COVID-19 as soon as possible.  Clinical trial material is currently available, since Tempol is an investigational drug currently in human trials for other indications."



    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 has entered into a distribution and commercialization agreement with US WorldMeds for the US commercial rights for SYMJEPI and ZIMHI.  The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs for human and veterinary use, 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.  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 relate to future events or future results of operations, including, but not limited to the following statements: the company's beliefs concerning the safety and effectiveness of the compounds and drugs described in this press release; the results of any future clinical trials that the company or Matrix may conduct relating to the compounds and drug product candidates described in this press release; the company's ability to fund future product development and trials; future revenues expected from any products that may be developed and approved for marketing by the FDA and other regulatory authorities; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the company's beliefs concerning the safety and effectiveness of any product candidates that may be developed; and the intellectual property protection that may be afforded by any of the licensed patents or patent applications.  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 can be no assurances regarding the timing, cost or outcome of any current or future trials that may be conducted relating to the compounds and products described in this press release.  There can be no assurances that we or any commercialization partners will file any New Drug Applications with the FDA regarding any of the compounds or products described in this press release, or that any such NDAs will be approved by the FDA.  In addition, forward-looking statements concerning our anticipated future activities assume that we can 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 Adamis' filings from time to time with the SEC, including its 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.

    Contacts:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951

    Primary Logo

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  4. SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the first quarter ended March 31, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are pleased to have resubmitted our ZIMHI New Drug Application to the FDA to get us back on track for regulatory review. We are also very excited to be partnering with US WorldMeds to commercialize both our SYMJEPI and ZIMHI products here in the U.S. Certainly, Adamis has been negatively affected by the COVID-19 outbreak and the various degrees of lockdowns, and it remains to be seen how quickly everyone can get back to a new normal. However, we…

    SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the first quarter ended March 31, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are pleased to have resubmitted our ZIMHI New Drug Application to the FDA to get us back on track for regulatory review. We are also very excited to be partnering with US WorldMeds to commercialize both our SYMJEPI and ZIMHI products here in the U.S. Certainly, Adamis has been negatively affected by the COVID-19 outbreak and the various degrees of lockdowns, and it remains to be seen how quickly everyone can get back to a new normal. However, we continue to operate and progress on a number of objectives. We will continue these efforts to mitigate the financial impact of the pandemic."

    Product Updates

    SYMJEPI (epinephrine) Injection

    Earlier this month, the company announced that it had entered into an agreement with Sandoz Inc. providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights to the company's SYMJEPI ® (epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection 0.15mg products currently marketed and available in the United States, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. Adamis also simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC (USWM) for the United States commercial rights for the SYMJEPI products as well as the Company's ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

    In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and in October 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

    ZIMHI (naloxone) Injection

    Adamis has entered into an exclusive distribution and commercialization agreement with USWM for the U.S. commercial rights for ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL product candidate. Under the terms of the Adamis/USWM agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz's commercial rights, and ZIMHI, if approved by the U.S. Food and Drug Administration, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, after deducting the supply price and certain other deductions, including an allocation for USWM sales and distribution expenses from net sales of the products, Adamis and USWM will share equally in the net profits, as defined in the agreement.

    Earlier today, the company announced the resubmission of the company's New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI product candidate. The resubmission follows the company's meeting with the agency in February and is intended to address the issues raised by the FDA in the agency's November 2019 Complete Response Letter ("CRL").

    Drug Outsourcing Facility

    During the first quarter of 2020, sterile and non-sterile revenues from the company's wholly owned drug outsourcing facility, US Compounding (USC), decreased by approximately 6% in the first quarter compared to the same quarter in the prior year. Revenues from the sale of pharmaceutical formulations by USC were adversely affected by slowing demand due to the novel coronavirus outbreak. The company is seeking to mitigate the impact with the development and launch of products for which there has been a recent increase in demand.     

    First Quarter Financial Results

    Revenues were approximately $4.7 million and $4.9 million for the three months ended March 31, 2020 and 2019, respectively. The decrease of approximately 5.0% in the first quarter of 2020 compared to the comparable period of 2019 was impacted by the effect of the pandemic on demand for USC's products. Specifically, hospitals cancelled elective and non-emergency procedures, pain clinics were either shutdown or experienced a significant drop in office visits during the first quarter and the horse racing industry shut down. 

    Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2020 and 2019 were approximately $6.1 million and $8.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses, and to a lesser extent by decreases in operational expenses relating to the ceasing of sales of certain USC products, and decreases in patent, consulting, outside services, professional fees, PDUFA fees, depreciation and other related expenses.

    Research and development expenses were approximately $2.0 million and $2.2 million for the three months ended March 31, 2020 and 2019, respectively, a decrease of approximately 7.3%. The decrease was primarily due to a decrease in development costs of our product candidates. 

    Cash and equivalents at the end of the first quarter was approximately $10.5 million. In February 2020, the company completed a registered direct offering of common stock, and a concurrent private placement of warrants, resulting in estimated net proceeds of approximately $6.2 million.

    Targeted Milestones  

    • Transition SYMJEPI commercial responsibility from Sandoz to USWM;
    • FDA approval and U.S. commercial launch of ZIMHI;
    • Develop and launch new USC products to help offset the impact of pandemic; and
    • Complete a Phase III ulcer study in horses.

    Conference Call
    Adamis will host a conference call and live webcast on Monday, May 18, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2020 as well as provide an update on business developments and activities.

    US Dial-in (Toll Free): 1-877-423-9813

    TOLL/International Dial-in: 1-201-689-8573

    Conference ID: 13703885

    Webcast: http://public.viavid.com/index.php?id=139872

    In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 18, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13703885.

    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. 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 relate to future events or future results of operations, including, but not limited to the following statements: the impact of the recent COVID-19 outbreak and overall economic outlook on the company's present and future operations, employees, suppliers, supply chain, manufacturers and commercial partners; the company's beliefs concerning its ability to satisfactorily respond to the matters raised in the FDA's Complete Response Letter (CRL) and to successfully develop the additional information requested by the FDA at the company's Type A meeting with the FDA; the timing and results of the FDA's review of the company's resubmitted NDA for ZIMHI; the company's beliefs concerning the results of studies or clinical trials that the company has conducted relating to ZIMHI or its other products or product candidates; the company's beliefs concerning its ability to commercialize ZIMHI and its other products and product candidates; the company's beliefs concerning the success of the transition of commercialization and marketing of its SYMJEPI products from Sandoz to USWM; 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; the company's beliefs concerning its commercialization strategies; the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product; statements about strategies, objectives and our future goals and achievements; future financial results of the company and its subsidiaries; future development and regulatory actions concerning the company's product candidates; the timing and progress of current and future clinical trials or studies; expectations and goals for future growth, including without limitation future growth in revenues from sales of compounded sterile pharmaceutical formulations; anticipated commencement and completion dates for clinical trials; product development timelines; anticipated dates for commercial introduction of products; guidance regarding future periods; and other statements concerning our future operations and activities. 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. There can be no assurances concerning the timing or outcome of future action by the FDA relating to our resubmitted NDA for ZIMHI. In addition, there can be no assurance that the FDA will conclude that the company's resubmitted NDA satisfactorily responds to the matters raised in the FDA's CRL or discussed in the Type A meeting, that the FDA will approve our resubmitted NDA relating to ZIMHI, or concerning the timing of any future action by the FDA on our resubmitted NDA. The FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated or target completion or action dates due to the timing of the FDA's review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission, issues relating to the COVID-19 pandemic, or other reasons. We 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 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. Failure to timely obtain required funding would adversely affect us and could require us to materially reduce or suspend operations or one or more clinical trials or other product development activities, or delay or prevent our ability to realize the results contemplated by such forward looking statements. In addition, 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, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, including its 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. Except to the extent required by law, any forward-looking statements in this press release speak only as the date of this press release, and Adamis expressly disclaims any obligation to update any forward-looking statements.

    Contacts:

    Mark Flather
    Senior Director, Investor Relations
    & Corporate Communications
    Adamis Pharmaceuticals Corporation
    (858) 412-7951


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  5. SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the resubmission of the Company's New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose. The resubmission follows the company's meeting with the agency in February and is intended to address the issues raised by the FDA in the agency's November 2019 Complete Response Letter ("CRL").

    Adamis previously announced that it entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC ("USWM") for commercial rights for the ZIMHI product candidate. Under the terms of the agreement, USWM…

    SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the resubmission of the Company's New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose. The resubmission follows the company's meeting with the agency in February and is intended to address the issues raised by the FDA in the agency's November 2019 Complete Response Letter ("CRL").

    Adamis previously announced that it entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC ("USWM") for commercial rights for the ZIMHI product candidate. Under the terms of the agreement, USWM obtained U.S. rights to commercialize and distribute the ZIMHI, if approved by the FDA, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, Adamis and USWM will share equally in the net profits, as defined in the agreement. Adamis has retained rights to commercialize the ZIMHI product outside the U.S. and may also continue to develop its injection platform for additional product candidates. Additional information concerning the agreement and the transaction is contained in a report on Form 8-K that has been filed by the company with the Securities and Exchange Commission.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our ZIMHI NDA. Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL. I feel the additional data addresses all the issues raised in the November CRL and we hope the FDA can expedite its review. With the rapid increase in synthetic opioid related deaths and the persistence of widespread opioid addiction, we believe that there remains a need for a higher dose treatment option to help combat this crisis."

    About ZIMHI
    ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. According to statistics published by the Centers for Disease Control and Prevention (CDC) in 2018, drug overdoses resulted in approximately 67,000 deaths in the United States – greater than 185 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50, and more powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses. On May 11, 2020, Adamis announced it entered into an exclusive distribution and commercialization agreement with USWM for U.S. commercial rights for the ZIMHI product.

    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.

    Contacts:

    Mark Flather
    Senior Director, Investor Relations
    & Corporate Communications
    Adamis Pharmaceuticals Corporation
    (858) 412-7951

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