1. SAN DIEGO, March 15, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Company") announced today that in studies conducted at Galveston National Laboratory (GNL), University of Texas Medical Branch (UTMB) at Galveston, hamsters challenged with the virus that causes COVID-19 (SARS-CoV-2), resulted in decreased inflammation in the lungs of animals treated with Tempol compared to controls. This is the first data demonstrating that Tempol, a novel antioxidant, can reduce inflammation in animals given the virus (SARS-CoV-2) that causes COVID-19. The group plans on submitting the publication to a peer review journal.

    Dr. Chien-Te Kent Tseng, Professor of the Department of Microbiology and Immunology and Director of GNL's…

    SAN DIEGO, March 15, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Company") announced today that in studies conducted at Galveston National Laboratory (GNL), University of Texas Medical Branch (UTMB) at Galveston, hamsters challenged with the virus that causes COVID-19 (SARS-CoV-2), resulted in decreased inflammation in the lungs of animals treated with Tempol compared to controls. This is the first data demonstrating that Tempol, a novel antioxidant, can reduce inflammation in animals given the virus (SARS-CoV-2) that causes COVID-19. The group plans on submitting the publication to a peer review journal.

    Dr. Chien-Te Kent Tseng, Professor of the Department of Microbiology and Immunology and Director of GNL's SARS/MERS/COVID-19 Laboratory at UTMB, commented on these results: "In our hamster COVID-19 model, pulmonary inflammation with cellular infiltrates and hemorrhage (mild-to-moderate) is triggered by SARS-CoV-2 infection. Treatment with Tempol reduces the overall inflammatory responses and appears to start repairing damaged lungs."

    These results are also consistent with the results that the Company announced regarding in-vitro cytokine data from Stanford University. The results demonstrated that incubation of Tempol significantly suppresses multiple inflammatory cytokines from cells taken from COVID-19 patients.

    Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). Tempol has now been shown to: (1) Decrease the proinflammatory cytokines (cytokine storm) in animal models (lipopolysaccharide induced), (2) Suppress cytokines in stimulated COVID-19 positive human cells, and (3) Reduce inflammation in hamsters challenged with COVID-19. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients.

    The new results demonstrating decreased lung inflammation in hamsters challenged and treated with Tempol are consistent with the design of the recent FDA allowed IND and protocol to study Tempol in early COVID-19 infection. The goal of the study titled, "A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection" is to examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study will examine markers of inflammation and the rate of hospitalization for patients taking Tempol versus placebo early in COVID-19 infection. More details of the protocol can be found here or by searching Clinicaltrials.gov. Dr. Ronald Moss, Chief Medical Officer of Adamis, commented: "These results from a validated animal model for COVID-19 provide further support on implementing our well-designed clinical trial in order to obtain activity and safety information on the use of Tempol in early COVID-19 infection in humans."

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, commented: "The results to date support the design of our clinical study in that we are targeting early infection with the objective of reducing lung inflammation and eventual hospitalization. We are hopeful that the clinical study will replicate the results obtained to date, i.e., preventing or ameliorating some of the most severe symptoms of COVID-19 caused by dysfunctional inflammation."

    In addition to Dr. Tseng, the UTMB team includes Drs. Aleksandra K. Drelich, Kempaiah Rayavara Kempaiah, and Bi-Hung Peng (Pathologist).

    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. 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 Tempol or the company's other product candidates; the timing of commencement or completion of studies or trials relating to Tempol; the results of any studies or trials that the company may conduct relating to Tempol; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; 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 the results anticipated by such forward-looking statements. There can be no assurances regarding the timing of commencement of trials relating to Tempol, the timing of completion of such trials or the outcome of such trials, that the company's planned Phase 2/3 study will produce results that are consistent with earlier preclinical or clinical studies or trials relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. 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 most recent annual report on Form 10-K and 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

    Adamis Pharmaceuticals Corporation

    (858) 412-7951



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  2. SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) --  Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Company") announced today that the U.S. Food and Drug Administration ("FDA") has completed the safety review of the Company's Investigational New Drug ("IND") application and has concluded that Adamis may proceed with the proposed clinical investigation of Tempol for the treatment of COVID-19. The clearance to proceed follows the submission of an IND application to FDA and a Pre-IND meeting.

    The goal of the study titled, "A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection," is to examine the safety…

    SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) --  Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Company") announced today that the U.S. Food and Drug Administration ("FDA") has completed the safety review of the Company's Investigational New Drug ("IND") application and has concluded that Adamis may proceed with the proposed clinical investigation of Tempol for the treatment of COVID-19. The clearance to proceed follows the submission of an IND application to FDA and a Pre-IND meeting.

    The goal of the study titled, "A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection," is to examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study will examine markers of inflammation and the rate of hospitalization for patients taking Tempol versus placebo early in COVID-19 infection. More details of the protocol can be found here or by searching Clinicaltrials.gov.

    "As the principal investigator of this study, I am excited to initiate this clinical trial to evaluate the role of Tempol to prevent serious complications and hospitalization in COVID-19 patients. We are in need of additional therapeutic options for COVID-19, and this novel antioxidant approach deserves a thorough investigation," noted Shyam Kottilil, MBBS, PhD, Professor of Medicine and Director of the Division of Clinical Care and Research at the Institute of Human Virology at the University of Maryland School of Medicine.

    Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients.

    Recently, in collaboration with investigators at the Human Immune Monitoring Center at Stanford University, preliminary data from a study to investigate the effects of Tempol on immune cells from COVID-19 patients showed that Tempol decreased cytokine production in stimulated COVID-19 positive human cells. Numerous published articles describing animal models of ARDS show Tempol caused a decrease in lung inflammation and preserved lung pathology associated with acute and chronic lung injury.

    Tempol has also been shown to have an impact on gene expression. Examples include:

    (1)   Glutathione s-transferase, regulators of oxidative stress - Tempol has been shown to significantly increase the enzyme gene expression, thereby protecting cells against the onslaught of oxidative stress from numerous sources;



    (2)   ADIPOQ gene, an inflammation regulatory gene - Tempol has been shown to significantly increase expression of ADIPQ, thereby regulating the expression of pro-inflammatory cytokines such as TNF∝ and IL-6; and



    (3)   HIF-1∝ and HIF-2∝, hypoxia inducible factors - Tempol has been shown to decrease the genes (HIF1∝ and HIF-2∝) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and poor outcome. Controlling hypoxia and the cytokine store can be considered essential to the successful treatment of COVID-19.



    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals commented: "With new mutations of COVID-19 continuing to occur, there is a distinct possibility that the current vaccines will be less effective. This also holds true for the current antibody products. As the virus continues to mutate, it is likely that this will have a negative impact on viral neutralization. This highlights how critically important it is to develop new therapeutic products. The consequences of cytokine storm caused by COVID-19 remain a major burden on our healthcare system, with few treatment options available. We are hopeful that this study will demonstrate the important role of Tempol in treating and preventing hospitalization and the severe after effects of COVID-19. If this trial is successful, we would likely petition the FDA to consider Emergency Use Authorization for Tempol as a therapeutic treatment for COVID-19".

    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. 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 Tempol; the timing of commencement of enrollment of patients, conduct or completion of any studies or trials relating to Tempol including the trial discussed in this press release; the results of any studies or trials that the company may conduct relating to Tempol; the impact of Tempol on gene expression; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the effectiveness of current or future COVID-19 vaccine products against new mutations of COVID-19; 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 the results anticipated by such forward-looking statements. There can be no assurances regarding the timing of commencement of patient enrollment for trials or studies relating to Tempol, or regarding the timing of the conduct and completion of such clinical trials; that the Tempol trial discussed in this press release will be successful; that future trials or studies regarding Tempol will produce results regarding the impact of Tempol of gene expression or other results that are consistent with the results in previous studies or trials; that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication; that we will apply for or that the FDA will grant any emergency use authorization for Tempol for Tempol as a therapeutic treatment for COVID-19; or regarding the effectiveness of current or future COVID-19 vaccine products against new mutations of COVID-19. 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 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

    Adamis Pharmaceuticals Corporation

    (858) 412-7951



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  3. 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…

    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



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  4. SAN DIEGO, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), today announced the closing of its underwritten public offering of 46,621,621 shares of its common stock, including 6,081,081 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, at the public offering price of $1.11 per share. As a result of the underwriters' exercise of the option, the aggregate gross proceeds to Adamis from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by the company, was approximately $51.7 million.

    Raymond James & Associates, Inc. acted as the sole book-running manager for the offering.

    The company intends to use…

    SAN DIEGO, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), today announced the closing of its underwritten public offering of 46,621,621 shares of its common stock, including 6,081,081 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, at the public offering price of $1.11 per share. As a result of the underwriters' exercise of the option, the aggregate gross proceeds to Adamis from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by the company, was approximately $51.7 million.

    Raymond James & Associates, Inc. acted as the sole book-running manager for the offering.

    The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

    The securities described above were offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A final prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at .

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamis Pharmaceuticals Corporation

    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, including statements regarding the public offering and the intended use of the net proceeds from the offering and statements about future developments relating to company's product candidates. 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 company's beliefs concerning the following statements: the intended use of proceeds from the offering described in this press release; and future developments regarding the company's products and product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the company's actual results to be materially different from these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made and should not be relied upon as representing the company's views as of any subsequent date, and except as may be required by applicable law, we expressly disclaim any, 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, 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:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951



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  5. SAN DIEGO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today the pricing of its previously announced underwritten public offering of 40,540,540 shares of its common stock at a public offering price of $1.11 per share, resulting in gross proceeds of approximately $45,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company. All shares of common stock to be sold in the public offering are being sold by Adamis.

    The offering is expected…

    SAN DIEGO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today the pricing of its previously announced underwritten public offering of 40,540,540 shares of its common stock at a public offering price of $1.11 per share, resulting in gross proceeds of approximately $45,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company. All shares of common stock to be sold in the public offering are being sold by Adamis.

    The offering is expected to close on February 2, 2021, subject to the satisfaction of customary closing conditions. The company has also granted the underwriters a 30-day option to purchase up to 6,081,081 additional shares of its common stock to cover over-allotments, if any.

    Raymond James & Associates, Inc. is acting as the sole book-running manager for the offering.

    The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

    The securities described above are being offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC's website at www.sec.gov. A final prospectus supplement and an accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at .

    Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamis Pharmaceuticals Corporation

    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, including statements regarding the public offering and the intended use of proceeds from the offering and statements about the progress of the company's product candidates. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. These forward-looking statements also are subject to risks, uncertainties and assumptions, including those detailed from time to time in the company's filings with the SEC, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date. The company's actual results may differ materially from those contemplated by these forward-looking statements. Except to the extent required by law, 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:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951

     



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  6. SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today that it intends to offer to sell shares of its common stock in an underwritten public offering. The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual…

    SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today that it intends to offer to sell shares of its common stock in an underwritten public offering. The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Raymond James & Associates, Inc. will act as the sole book-running manager for the proposed offering.

    The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

    The securities described above will be offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (SEC) on July 18, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at , or by accessing the SEC's website at www.sec.gov.

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about the company.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamis Pharmaceuticals Corporation

    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, including statements regarding the proposed public offering and the intended use of proceeds from the offering and statements about the progress of development of the company's product candidates. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. These forward-looking statements also are subject to risks, uncertainties and assumptions, including those detailed from time to time in the company's filings with the SEC, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date. The company's actual results may differ materially from those contemplated by these forward-looking statements. Except to the extent required by law, 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.

    Contacts:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951



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  7. SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") in collaboration with the Human Immune Monitoring Center at Stanford University have conducted a study to investigate the effects of Tempol on immune cells from COVID-19 patients. Preliminary data from that study shows that Tempol decreases cytokines from stimulated cells from COVID-19 patients. The collaboration expects to submit the final data to a peer reviewed journal.

    Tempol has previously demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory…

    SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") in collaboration with the Human Immune Monitoring Center at Stanford University have conducted a study to investigate the effects of Tempol on immune cells from COVID-19 patients. Preliminary data from that study shows that Tempol decreases cytokines from stimulated cells from COVID-19 patients. The collaboration expects to submit the final data to a peer reviewed journal.

    Tempol has previously demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous 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. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.   Tempol could potentially be used to treat the many manifestations of COVID-19 and prevent severe disease as well as the need for hospitalization.

    Dr. Dennis J. Carlo, President and CEO of Adamis commented: "We are very excited about the collaboration with Stanford University. This is the first data that we know of that shows Tempol has a positive impact in decreasing cytokine production from COVID-19 positive patient cells. These data further support the need for clinical studies of Tempol in COVID-19 patients. We intend to continue pursuing government and/or non-government funding for these studies; however, the recent exercise of outstanding warrants have provided the company with additional capital which may be used to help support and/or accelerate Tempol clinical studies."

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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, U.S. 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. 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 Tempol or the company's other product candidates; the timing of funding for, or commencement or completion of, any studies or trials relating to Tempol; the availability of, and the company's success in applying for and obtaining, government or other funding for studies or trials relating to Tempol or the timing or amount of any such funding; the results of any future studies or trials that the company may conduct relating to Tempol; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; 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 the results anticipated by such forward-looking statements. There can be no assurances regarding the outcome of our submission of the IND relating to investigational use of, or trials or studies relating to, Tempol, regarding the timing or the outcome of any applications or requests that we may submit for government or other funding for studies or trials relating to Tempol; concerning the timing or outcome of any such studies or trials; or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. 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 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 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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  8. SAN DIEGO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that it has entered into a non-binding letter of intent with a potential buyer for sale of substantially all of the assets of its US Compounding Inc. (USC) subsidiary. Under the terms described in the letter of intent, the buyer would agree to acquire substantially all of the assets of US Compounding in exchange for a total gross consideration that could range from approximately $10-20 million, before transaction fees and expenses and other potential post-closing adjustments.

    If a transaction is negotiated, reflected in definitive agreements entered into by the parties, and completed, the proposed purchase price consideration includes…

    SAN DIEGO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that it has entered into a non-binding letter of intent with a potential buyer for sale of substantially all of the assets of its US Compounding Inc. (USC) subsidiary. Under the terms described in the letter of intent, the buyer would agree to acquire substantially all of the assets of US Compounding in exchange for a total gross consideration that could range from approximately $10-20 million, before transaction fees and expenses and other potential post-closing adjustments.

    If a transaction is negotiated, reflected in definitive agreements entered into by the parties, and completed, the proposed purchase price consideration includes a combination of a cash payment at the closing of the transaction, a promissory note representing portion of the purchase price payable at a future date, and potential future performance-based milestone payments over a period of years. The amount and structure of consideration could change as a result of subsequent negotiations, due diligence or other factors.

    Any definitive agreement would be subject to approval by the respective parties, including approval by the board of directors of Adamis, and would likely include a number of customary provisions, including without limitation representations and warranties of Adamis and USC, restrictive covenants and indemnification provisions.

    The closing of a transaction would be contingent on the satisfaction of closing conditions which might include, among other things: (i) the receipt of required governmental, regulatory, and third-party consents and approvals, (ii) buyer obtaining required licenses, permits, registrations, or other approvals from the necessary state boards of pharmacy and other state and federal governmental authorities, and (iii) other customary closing conditions.

    The letter of intent is non-binding other than with respect to certain customary confidentiality and exclusivity provisions. There can be no assurances that the parties will negotiate and enter into definitive transaction agreements, the final terms that might be included in any definitive agreements, whether a transaction will be completed, or concerning the timing of closing of any such transaction.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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, U.S. 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.

    About US Compounding

    In April 2016, Adamis acquired US Compounding Inc. (USC) which is registered as a drug compounding outsourcing facility under Section 503B of the FDCA and the U.S. Drug Quality and Security Act, or DQSA, and which provides prescription compounded medications, including compounded sterile preparations and nonsterile compounds, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States. USC's product offerings broadly include, among others, corticosteroids, hospital outsourcing products, and injectables. USC also provides compounded pharmaceutical products for animals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to a number of risks and uncertainties. These statements relate to future events our future results of operations, including without limitation: whether Adamis and USC will negotiate any definitive agreements regarding the sale of USC's business and assets, the terms of any such definitive agreement, the timing of completion of any such transaction, and the amount of gross consideration that Adamis and USC may receive at the closing of any such transaction or pursuant to the promissory note or potential future contingent milestone payments contemplated by the letter of intent or any definitive agreement. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. There can be no assurances that Adamis or USC will enter into any definitive agreements for the sale of the business and assets of USC or that, if such an agreement is entered into, it will be completed, or concerning the time when the proposed transaction contemplated by the letter of intent might be completed. 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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  9. SAN DIEGO, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its SYMJEPI® (epinephrine) Injection products are now available to members of the Walgreens Prescription Savings Club program, for a discounted price of $99.99 for a two-pack, the lowest price offered for epinephrine products through the Walgreens Prescriptions Savings Club, and the lowest price for epinephrine devices on the market1.

    At the start of 2021, Adamis' SYMJEPI 0.3mg and SYMJEPI 0.15mg Injection products, which are used in the emergency treatment of acute allergic reactions, were added to the Walgreens Prescription Savings Club program. The Walgreens Prescription Savings Club offers customers, who pay an annual…

    SAN DIEGO, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its SYMJEPI® (epinephrine) Injection products are now available to members of the Walgreens Prescription Savings Club program, for a discounted price of $99.99 for a two-pack, the lowest price offered for epinephrine products through the Walgreens Prescriptions Savings Club, and the lowest price for epinephrine devices on the market1.

    At the start of 2021, Adamis' SYMJEPI 0.3mg and SYMJEPI 0.15mg Injection products, which are used in the emergency treatment of acute allergic reactions, were added to the Walgreens Prescription Savings Club program. The Walgreens Prescription Savings Club offers customers, who pay an annual membership fee, significant savings off retail prices on thousands of medications. For full details visit www.walgreens.com/psc/prescription-savings-club.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, added, "We are very excited Walgreens has added SYMJEPI through its Prescription Savings Club and feel this program will avail this potentially life-saving medication to the patients that need it most. Adamis remains committed to making SYMJEPI the most affordable epinephrine product available to patients."

    Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    • You should get emergency medical care right away after using SYMJEPI.
    • You may need to use a second SYMJEPI (epinephrine) injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
    • SYMJEPI should only be injected into the middle of your outer thigh (upper leg) with the needle facing downwards. Never inject into any other part of the body. If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. SYMJEPI can be injected through your clothing if needed.
    • The needle cap on the SYMJEPI prefilled syringe helps to prevent needle sticks and accidental injection of epinephrine. Do not remove the needle cap until you are ready to use it.
    • Never put your thumb, fingers, or hand over the exposed needle.
    • If an accidental injection happens, get medical help right away.
    • Do not drop the carrier case or SYMJEPI prefilled syringe. If the carrier case or prefilled syringe is dropped, check for damage and leakage. Dispose of the prefilled syringe and carrier case, and replace if damage or leakage is noticed or suspected.
    • Do not place patient information or any other foreign objects in the carrier case with the prefilled syringe, as this may prevent you from removing the prefilled syringe for use.
    • If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during injection.



    • Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:
      • have heart problems or high blood pressure.
      • have diabetes.
      • have thyroid problems.
      • have asthma.
      • have a history of depression.
      • have Parkinson's disease.
      • are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
      • are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

    Adverse Reactions

    SYMJEPI may cause serious side effects.

    • Rarely, patients who have used SYMJEPI may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
      • redness that does not go away
      • swelling
      • tenderness
      • the area feels warm to the touch
    • Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during the injection.
    • If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your SYMJEPI. Talk to your healthcare provider about all your medical conditions.

    Common side effects of SYMJEPI include:

    • fast, irregular or "pounding" heartbeat
    • sweating
    • headache
    • weakness
    • shakiness
    • paleness
    • feelings of over excitement, nervousness or anxiety
    • dizziness
    • nausea and vomiting
    • breathing problems

    These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.

    Drug Interactions

    • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Tell your healthcare provider of all known allergies.
    • Especially tell your healthcare provider if you take certain asthma medicines.
    • SYMJEPI and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.
    • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    Please see full Prescribing Information for SYMJEPI.

    To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    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. In addition to its ZIMHI, naloxone injection product candidate, Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company's subsidiary, U.S. 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. 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 commercialization of SYMJEPI and its other products and product candidates; the extent of sales of SYMJEPI resulting from the availability of the products within the Walgreens Prescription Savings Club program; and the company's beliefs concerning the ability of its product to compete successfully in the market; the company's beliefs concerning the safety and effectiveness of SYMJEPI or its other products and product candidates. 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. You should not place undue reliance on any forward-looking statements. There are no assurances regarding the extent of sales of SYMJEPI products, or revenues to the company, resulting from the availability of the products within the Walgreens Prescription Savings Club program. 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, 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

    ______________________________

    1 ProspectoRx data for epinephrine devices, December 2020.



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  10. SAN DIEGO, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). The submission of the IND to FDA followed a Pre-IND meeting with FDA in which FDA gave specific recommendations on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects to be included in the IND. The Company plans to seek government and/or non-government funding to study the treatment and prevention of COVID-19 with Tempol.

    Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species…

    SAN DIEGO, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). The submission of the IND to FDA followed a Pre-IND meeting with FDA in which FDA gave specific recommendations on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects to be included in the IND. The Company plans to seek government and/or non-government funding to study the treatment and prevention of COVID-19 with Tempol.

    Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous 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. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.

    Dr. Dennis J. Carlo, President and CEO of Adamis commented: "With over 23 million COVID-19 infections in the US and over 394,000 deaths in the US (according to the CDC), additional treatments are urgently warranted. We believe that Tempol could play a pivotal role not only in the treatment of COVID-19, but actually in preventing hospitalization. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. The South African and other variants could very well evade the protection of antibody treatments and also bring up concerns about the efficacy of the current COVID-19 vaccines. Mutations can possibly render these vaccines less potent and could require them to be updated as with influenza vaccines."

    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. In addition to its ZIMHI, naloxone injection product candidate, Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, and asthma. The company's subsidiary, U.S. 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. 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 Tempol or the company's other product candidates; the timing of funding for, or commencement or completion of, any studies or trials relating to Tempol; the availability of, and the company's success in applying for and obtaining, government or other funding for studies or trials relating to Tempol or the timing or amount of any such funding; the results of any future studies or trials that the company may conduct relating to Tempol; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; 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 the results anticipated by such forward-looking statements. There can be no assurances regarding the outcome of our submission of the IND relating to investigational use of, or trials or studies relating to, Tempol, regarding the timing or the outcome of any applications or requests that we may submit for government or other funding for studies or trials relating to Tempol; concerning the timing or outcome of any such studies or trials; or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. 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 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 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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  11. SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced a planned response to a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding its New Drug Application (NDA) for Adamis' ZIMHI high dose naloxone injection product for the treatment of opioid overdose.

    The CRL, received November 13, 2020, identified deficiencies that the FDA determined must be corrected before the Agency can approve the NDA, and provided recommendations needed for resubmission. FDA had not previously identified those deficiencies. Adamis intends to address all the deficiencies raised in the CRL and request that FDA approve the NDA. All of the company's responses to the deficiencies…

    SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced a planned response to a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding its New Drug Application (NDA) for Adamis' ZIMHI high dose naloxone injection product for the treatment of opioid overdose.

    The CRL, received November 13, 2020, identified deficiencies that the FDA determined must be corrected before the Agency can approve the NDA, and provided recommendations needed for resubmission. FDA had not previously identified those deficiencies. Adamis intends to address all the deficiencies raised in the CRL and request that FDA approve the NDA. All of the company's responses to the deficiencies will be submitted before year end. The company will then ask the FDA for a Type A meeting. If the matter cannot be resolved with the FDA Division that sent the CRL, Adamis intends to appeal the matter within the agency through a Formal Dispute Resolution.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We believe our high dose naloxone product (ZIMHI) offers a greater possibility to save lives given the high rates of synthetic opioid (fentanyl) overdoses. As the COVID-19 pandemic increases, the number of deaths due to opioid overdoses has also risen. Currently, only lower dose naloxone products are available. Recently, the injectable Evzio products have been discontinued, leaving no available intramuscular products approved for the layperson. This leaves a therapeutic vacuum that our high dose product would automatically fill and potentially save thousands of lives."

    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.

    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. In addition to its ZIMHI, naloxone injection product candidate, Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company's subsidiary, U.S. 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. 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 its ability to satisfactorily respond to the matters raised in the FDA's CRL; the company's beliefs concerning the information, data and actions that the FDA may require in connection with any resubmitted New Drug Application (NDA) relating to ZIMHI; the company's beliefs concerning the timing and outcome of any appeal and formal dispute resolution process that the company may initiate; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI; 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; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product. 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. 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. 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. 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, 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



    Primary Logo

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  12. SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis' ZIMHI™ high dose naloxone injection product for the treatment of opioid overdose. The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.

    A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form…

    SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis' ZIMHI™ high dose naloxone injection product for the treatment of opioid overdose. The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.

    A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  The questions raised by the FDA related generally to new Chemistry, Manufacturing and Controls (CMC) issues. It should be noted that no issues related to "extractables and leechables testing", that were associated with the previous initial CRL that the company received relating to the product, were noted by the FDA. The company's plan is to provide the FDA with additional analysis and information in order to attempt to satisfy the CRL items. The company will request a Type A meeting or consider other options to resolve the issues.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "This is a very disappointing setback that was totally unexpected since we completed the extractables and leechables issues that were associated with the first CRL. To me, it is very surprising to have new issues brought up this late in the review process. We believe the comments and recommendations stated in the CRL can be addressed and overcome. With all of the factors that are currently contributing to a growing number of fatal overdoses during the COVID-19 pandemic, we believe there is a clear need for higher dose forms of intramuscular naloxone found in ZIMHI. We remain committed to this product and our mission to provide physicians and patients access to a higher dose of naloxone. As soon as reasonably possible, we will resubmit additional information and analysis of data to the FDA for the NDA."

    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.

    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.  In addition to its ZIMHI, naloxone injection product candidate, Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD.  The company's subsidiary, U.S. 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.

    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 its ability to satisfactorily respond to the matters raised in the FDA's CRL; the company's beliefs concerning the information, data and actions that the FDA may require in connection with any resubmitted NDA relating to ZIMHI; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI or its other products or product candidates; the company's beliefs concerning the timing and outcome of the FDA's review of the company's New Drug Application (NDA) relating to the ZIMHI product or any resubmitted NDA; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product. 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. The FDA may require additional studies, and/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, or that the product will be able to compete successfully in the market if approved and launched. 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.  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, 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.

    Contact Adamis:



    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    (858) 412-7951



    Primary Logo

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  13. SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are excited to have US WorldMeds in full control of our SYMJEPI product now that the transition from Sandoz has been completed. We expect to see the full impact of this transition going forward and I expect 2021 to be the breakout year for this product. We and our commercial partner eagerly await the FDA's decision on our ZIMHI NDA which has a target PDUFA date of November 15th. We remain very excited about the remainder of this year and…

    SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are excited to have US WorldMeds in full control of our SYMJEPI product now that the transition from Sandoz has been completed. We expect to see the full impact of this transition going forward and I expect 2021 to be the breakout year for this product. We and our commercial partner eagerly await the FDA's decision on our ZIMHI NDA which has a target PDUFA date of November 15th. We remain very excited about the remainder of this year and beyond."

    Product Updates

    SYMJEPI (epinephrine) Injection

    On July 1, 2020, Adamis' new commercial partner, USWM began promoting SYMJEPI® (epinephrine) Injection 0.3mg and SYMJEPI® (epinephrine) Injection 0.15mg products through its field sales force in the U.S. USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians. The transition of sales and distribution from Sandoz to USWM was completed on October 31, 2020 and now USWM is fully responsible for sales and distribution of SYMJEPI.

    The company's Australian partner, Emerge Health, which was acquired by Chiesi Farmaceutica in June, continues to work through the regulatory process with the Therapeutic Goods Administration (TGA) in Australia and the company expects a decision from the TGA sometime in the first half of 2021.

    ZIMHI (naloxone) Injection

    The FDA has provided a target action date (PDUFA) of November 15, 2020 with respect to the company's resubmitted New Drug Application (NDA) relating to ZIMHI. The company continues to work with its commercial partner, as USWM prepares for the commercial launch of ZIMHI.

    Tempol

    Since licensing this product, the company has made some progress on the development of Tempol. Unfortunately, few therapies have been successful so far for the treatment of COVID-19. In preliminary results from a study in collaboration with Stanford University, Tempol inhibits the release of multiple cytokines from activated immune cells of COVID-19 patients. This new data now provides the additional scientific rationale needed to conduct clinical studies in early COVID-19 patients with Tempol. We are currently identifying sites that could conduct this trial. With the additional data from this study, the company continues to explore its options for government and other forms of funding to potentially support additional testing of Tempol.

    Discussions with various groups continue to evolve on the funding and design of a large clinical study to examine the effects of Tempol for the treatment of radiation induced dermatitis. One of these groups, which was previously under the direction Dr. Stephen Hahn (current FDA commissioner), conducted successful clinical studies of Tempol for the treatment of radiation induced alopecia.

    Drug Outsourcing Facility

    Year to date, sterile and non-sterile revenues from the company's wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the COVID-19 outbreak. Revenues decreased by approximately 21% for the nine months ended September 30, 2020, compared to the same period in the prior year.

    Third Quarter Financial Results

    Revenues were approximately $4.3 million and $5.9 million for the three months ended September 30, 2020 and 2019, respectively. This decrease in revenues of approximately 27% year over year was primarily due to the COVID-19 pandemic which has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians' offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC's customers for certain of USC's products.

    Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were approximately $5.8 million and $5.3 million, respectively.

    Research and development expenses were approximately $1.7 million and $3.3 million for the three months ended September 30, 2020 and 2019, respectively. The decrease was primarily due to completing work on ZIMHI and a decrease in development costs of our other product candidates.

    Cash and equivalents at the end of the third quarter was approximately $12.4 million. This amount includes proceeds from an equity offering completed in September which provided net proceeds of approximately $10.7 million.

    Targeted Milestones

    • FDA approval and U.S. commercial launch of ZIMHI;
    • Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
    • Ex-US partnerships for SYMJEPI and ZIMHI.

    Conference Call

    Adamis will host a conference call and live webcast on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.

    US Dial-in (Toll Free): 1-855-327-6838

    TOLL/International Dial-in: 1-604-235-2082

    Conference ID: 10011804

    Webcast: http://public.viavid.com/index.php?id=142367

    In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 9, 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 10011804.

    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 with a target action date of November 15, 2020. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company's subsidiary, U.S. 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.

    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 COVID-19 outbreak and overall economic outlook on the company's present and future operations, employees, suppliers, supply chain, manufacturers and commercial partners; 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; the company's beliefs concerning the timing or outcome of discussions with the FDA or others concerning the design and funding for trials relating to use of Tempol as a therapeutic treatment for COVID-19 or radiation induced dermatitis, or the timing or outcome of any such trials; 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 previous Complete Response Letter, 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

    Primary Logo

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  14. SAN DIEGO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.  The company's press release concerning its third quarter 2020 financial results will be available after 1:00 p.m. Pacific Time on November 9, 2020, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the third quarter ended September 30, 2020, on that date. 

    Event: Adamis Pharmaceuticals Third Quarter 2020…

    SAN DIEGO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.  The company's press release concerning its third quarter 2020 financial results will be available after 1:00 p.m. Pacific Time on November 9, 2020, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the third quarter ended September 30, 2020, on that date. 

    Event: Adamis Pharmaceuticals Third Quarter 2020 Conference Call

    Date: Monday, November 9, 2020

    Time: 2:00 pm PT (5:00 pm ET)

    US Dial-in (Toll Free): 1-855-327-6838

    TOLL/International Dial-in: 1-604-235-2082

    Conference ID:  10011804

    Dr. Dennis J. Carlo, President and CEO of Adamis, will host the call along with other members of the management team.  The call is open to the public and will provide an update on recent developments, events that have taken place during this quarter and certain target milestones and goals for future periods.  Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

    A live audio webcast of the conference call will also be available via this link – http://public.viavid.com/index.php?id=142367.  Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 9, 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 10011804.

    About Adamis

    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 with a target action date of November 15, 2020. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD.  The company's subsidiary, U.S. 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.

    Contact



    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951

    Primary Logo

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  15. SAN DIEGO, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today the pricing of its previously announced underwritten public offering of 16,129,032 shares of its common stock at a public offering price of $0.62 per share, resulting in gross proceeds of approximately $10,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company. All shares of common stock to be sold in the public offering are being sold by Adamis.

    The offering is expected…

    SAN DIEGO, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today the pricing of its previously announced underwritten public offering of 16,129,032 shares of its common stock at a public offering price of $0.62 per share, resulting in gross proceeds of approximately $10,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company. All shares of common stock to be sold in the public offering are being sold by Adamis.

    The offering is expected to close on September 22, 2020, subject to the satisfaction of customary closing conditions. The company has also granted the underwriters a 30-day option to purchase up to 2,419,354 additional shares of its common stock to cover over-allotments, if any.

    Raymond James & Associates, Inc. is acting as the sole book-running manager for the offering. Maxim Group LLC is acting as lead manager for the offering.

    The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

    The securities described above are being offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC's website at www.sec.gov. A final prospectus supplement and an accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at .

    Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamis Pharmaceuticals Corporation

    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, U.S. 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, including statements regarding the public offering and the intended use of proceeds from the offering and statements about the progress of the commercialization of its epinephrine pre-filled syringe product and the development of the company's product candidates. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. These forward-looking statements also are subject to risks, uncertainties and assumptions, including those detailed from time to time in the company's filings with the SEC, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date. The company's actual results may differ materially from those contemplated by these forward-looking statements. Except to the extent required by law, 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.

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  16. SAN DIEGO, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today that it intends to offer to sell shares of its common stock in an underwritten public offering.  The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering.  The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the…

    SAN DIEGO, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, announced today that it intends to offer to sell shares of its common stock in an underwritten public offering.  The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering.  The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Raymond James & Associates, Inc. will act as the sole book-running manager for the proposed offering.

    The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

    The securities described above will be offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (SEC) on July 18, 2018.  A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC.  Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at , or by accessing the SEC's website at www.sec.gov.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamis Pharmaceuticals Corporation

    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, U.S. 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, including statements regarding the proposed public offering and the intended use of proceeds from the offering and statements about the progress of development of the company's product candidates.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.  These forward-looking statements also are subject to risks, uncertainties and assumptions, including those detailed from time to time in the company's filings with the SEC, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date.  The company's actual results may differ materially from those contemplated by these forward-looking statements.  Except to the extent required by law, 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.

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  17. SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the results of its reconvened 2020 annual meeting of stockholders which was initially held August 20, 2020, and was adjourned until September 3, 2020.  At the reconvened meeting, the stockholders voted on a proposal to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock, and a proposal to approve an amendment to the company's restated certificate of incorporation to implement a reverse stock split of the outstanding common stock, if the board of directors in its discretion determines to implement a reverse stock split as described in the company's…

    SAN DIEGO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the results of its reconvened 2020 annual meeting of stockholders which was initially held August 20, 2020, and was adjourned until September 3, 2020.  At the reconvened meeting, the stockholders voted on a proposal to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock, and a proposal to approve an amendment to the company's restated certificate of incorporation to implement a reverse stock split of the outstanding common stock, if the board of directors in its discretion determines to implement a reverse stock split as described in the company's proxy statement relating to the meeting.

    A majority of the outstanding shares of common stock entitled to vote at the meeting approved the proposal to amend the company's restated certificate of incorporation to increase the number of authorized shares of common stock by 100 million shares and the proposal was approved.  The company has filed a certificate of amendment to its restated certificate of incorporation to increase the number of authorized shares from 100 million to 200 million shares of common stock.  Other than the conversion of one million preferred shares into an equal number of shares of common stock, the filing will not impact the number of shares of common stock currently outstanding.

    Although the reverse stock split proposal was approved by a majority of the votes cast at the meeting, it did not receive approval by a majority of the outstanding shares entitled to vote at the meeting.  As a result, the reverse stock split proposal was not approved, and the Board of Directors will now take no further action to implement a reverse stock split.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are pleased with the outcome of the annual meeting and most appreciative of the efforts of our shareholders to participate in the process.  We now eagerly look ahead to what we expect to be an approval and a commercial launch of ZIMHI before year end."

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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, U.S. 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 that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs.  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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  18. SAN DIEGO, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided additional information concerning the proposals to be considered at its adjourned 2020 annual meeting of stockholders, which will resume on September 3, 2020 at 10:00 a.m. Pacific Time.  The proposals, described as Proposals 2 and 3 in the company's definitive proxy statement filed with the Securities and Exchange Commission on July 11, 2020, as supplemented by any supplements or amendments thereto, are (i) to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock (the "increase in authorized shares proposal"), and (ii) to approve an amendment to the company's…

    SAN DIEGO, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided additional information concerning the proposals to be considered at its adjourned 2020 annual meeting of stockholders, which will resume on September 3, 2020 at 10:00 a.m. Pacific Time.  The proposals, described as Proposals 2 and 3 in the company's definitive proxy statement filed with the Securities and Exchange Commission on July 11, 2020, as supplemented by any supplements or amendments thereto, are (i) to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock (the "increase in authorized shares proposal"), and (ii) to approve an amendment to the company's restated certificate of incorporation to implement a reverse stock split of the outstanding common stock, if the board of directors in its discretion determines to implement a reverse stock split before December 31, 2020 (the "reverse split proposal").

    While management continues to recommend that shareholders approve both Proposals 2 and 3, the company intends to take the actions described below under the following scenarios:

    1. If both Proposal 2 and 3 are approved - the company will amend its restated certificate of incorporation to authorize an additional 100 million shares of common stock, as described in Proposal 2 but does not intend to also implement a reverse stock split as described in Proposal 3.

       
    2. If Proposal 2 is approved and Proposal 3 is not approved - the company will amend its restated certificate of incorporation to authorize an additional 100 million shares of common stock, as described in Proposal 2 and will not implement a reverse stock split as described in Proposal 3.

       
    3. If Proposal 3 is approved and Proposal 2 is not approved – as described in the company's proxy statement, pursuant to its February 2020 securities purchase agreement with certain investors (the "February agreement"), the company will implement a reverse stock split promptly after the meeting and will determine the ratio of the reverse stock split as described in the proxy statement. 

       
    4. If neither Proposal 2 or 3 is approved – as described in the proxy statement, under the February agreement the company agreed to call additional meetings of stockholders each four months after the initial meeting at which the proposals were considered, to seek stockholder approval of at least one of the proposals until the date that stockholder approval is obtained. 

    The adjourned meeting will be a completely "virtual" meeting of stockholders, and stockholders will be able to listen and participate in the virtual meeting as well as vote and submit questions during the live webcast of the meeting by visiting www.virtualshareholdermeeting.com/ADMP2020.  To participate in the virtual meeting, stockholders will need the control number found on their proxy card or in the instructions that accompanied their proxy materials. Only stockholders of record on the record date of June 23, 2020, are entitled to vote.  Stockholders who have previously submitted their proxy or otherwise voted with respect to the proposals to be considered at the adjourned meeting and who do not want to change their vote need not take any action.

    As described in the proxy statement, a stockholder may use one of the following methods to vote before the September 3, 2020 adjourned meeting with respect to Proposal 2 and Proposal 3:

    Voting by Telephone, 1-800-690-6903, or Internet, www.proxyvote.com:  If you are a holder of record of shares, you can choose to vote by telephone or by Internet.  You can vote by telephone by calling the toll-free telephone number on your proxy card, 1-800-690-6903.  The website for Internet voting is http://www.proxyvote.com and it is also listed on the proxy card.  Please have your proxy card, which includes your stockholder control number, handy when you call or go online.  Telephone and Internet voting facilities for stockholders of record will close with respect to the adjourned meeting at 11:59 p.m., Eastern Standard Time, on September 2, 2020.  If you hold your shares beneficially in street name, the availability of telephonic or Internet voting will depend on the voting process of your broker, trustee or other nominee.  Please check with your broker, trustee or other nominee and follow the voting procedures your broker, trustee or other nominee provides to vote your shares.

    Voting Via the Virtual Annual Meeting Website.  To vote during the virtual Meeting, follow the instructions posted at www.virtualshareholdermeeting.com/ADMP2020.   

    Vote by Mail:  Stockholders of record (that is, if you hold your stock in your own name) may sign and date the proxy card you receive and return it in the enclosed stamped, self-addressed envelope.

    If your shares are held in the name of a bank, broker, trustee or other nominee holder of record (i.e., in "street name"), you should follow the instructions from the holder of record that you must follow in order for your shares to be voted.  The company encourages any stockholder whose shares are held in street name to contact their bank, broker, trustee or other nominee.  Telephone and Internet voting generally will be offered to stockholders owning shares through most banks and brokers by following the instruction form provided to you by your broker, bank, trustee, or other nominee.

    Important Information

    In connection with the solicitation of proxies, on July 10, 2020, Adamis Pharmaceuticals Corporation filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") in connection with the Company's 2020 annual meeting of stockholders, and filed a Supplement No. 1 to the Proxy Statement with the SEC on August 7, 2020.  The company's stockholders are strongly advised to read the definitive proxy materials, as supplemented or amended, and any other relevant solicitation materials filed by the company with the SEC before making any voting or investment decision because these documents contain important information.  The company's proxy statement and any other materials filed by the company with the SEC can be obtained free of charge at the SEC's web site at www.sec.gov.  The company's proxy statement, notice of annual meeting, and annual report to shareholders are available free of charge on the company's website at http://www.adamispharmaceuticals.com.  The contents of the website referenced above are not deemed to be incorporated by reference into the proxy statement.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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, U.S. 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 that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs.  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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  19. SAN DIEGO, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its 2020 Annual Meeting of Stockholders ("Annual Meeting"), convened on Thursday, August 20, 2020, has been adjourned and will resume on September 3, 2020 at 10:00 a.m. Pacific Time, to permit additional time for solicitation of proxies with respect to two of the proposals described in the company's notice of meeting and definitive proxy statement filed with the Securities and Exchange Commission on July 11, 2020 and any supplements thereto, to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock, and to approve an amendment to the company's restated…

    SAN DIEGO, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its 2020 Annual Meeting of Stockholders ("Annual Meeting"), convened on Thursday, August 20, 2020, has been adjourned and will resume on September 3, 2020 at 10:00 a.m. Pacific Time, to permit additional time for solicitation of proxies with respect to two of the proposals described in the company's notice of meeting and definitive proxy statement filed with the Securities and Exchange Commission on July 11, 2020 and any supplements thereto, to approve an amendment to the company's restated certificate of incorporation to increase the number of authorized shares of common stock, and to approve an amendment to the company's restated certificate of incorporation to implement a reverse stock split of the outstanding common stock, if the board of directors in its discretion determines to implement a reverse stock split, as described in the proxy statement.  The adjourned meeting will be a completely "virtual" meeting of stockholders, and stockholders will be able to listen and participate in the virtual meeting as well as vote and submit questions during the live webcast of the meeting by visiting www.virtualshareholdermeeting.com/ADMP2020.  To participate in the virtual meeting, stockholders will need the control number found on their proxy card or in the instructions that accompanied their proxy materials. Only stockholders of record on the record date of June 23, 2020, are entitled to vote. Prior to adjournment, the director nominees proposed for election in the company's definitive proxy statement were elected and the other proposals described in the notice of meeting and proxy statement, other than the two proposals described above, were voted on.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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 with a target action date of November 15, 2020. In May 2020, the Company announced a partnership with US WorldMeds for the commercialization of SYMJEPI and, if approved by the FDA, ZIMHI.  Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD.  The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, and surgery centers 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 that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs.  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.

    Important Information

    In connection with the solicitation of proxies, on July 10, 2020, Adamis Pharmaceuticals Corporation filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") in connection with the Company's 2020 annual meeting of stockholders, and filed a Supplement No. 1 to the Proxy Statement with the SEC on August 7, 2020.  The company's stockholders are strongly advised to read the definitive proxy materials, as supplemented, and any other relevant solicitation materials filed by the company with the SEC before making any voting or investment decision because these documents contain important information.  The company's proxy statement and any other materials filed by the company with the SEC can be obtained free of charge at the SEC's web site at www.sec.gov.  The company's proxy statement, notice of annual meeting, and annual report to shareholders are available free of charge on our website at http://www.adamispharmaceuticals.com.  The contents of the website referenced above are not deemed to be incorporated by reference into the proxy statement.

    Contacts:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    Adamis Pharmaceuticals Corporation

    (858) 412-7951

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  20. SAN DIEGO, Calif., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Although we continue to be negatively impacted by the pandemic and government required operating restrictions, we are very excited about several developments during the last quarter.  First, we finalized our agreement with Sandoz, Inc. to take back U.S. commercial rights for our SYMJEPI® products.  More importantly, we executed a new agreement with US WorldMeds, LLC (USWM) under which they have assumed U.S. rights to market and distribute…

    SAN DIEGO, Calif., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Although we continue to be negatively impacted by the pandemic and government required operating restrictions, we are very excited about several developments during the last quarter.  First, we finalized our agreement with Sandoz, Inc. to take back U.S. commercial rights for our SYMJEPI® products.  More importantly, we executed a new agreement with US WorldMeds, LLC (USWM) under which they have assumed U.S. rights to market and distribute the SYMJEPI products and, upon FDA approval which we believe will occur this year, will have commercial rights for our ZIMHI™ product.  I strongly feel USWM's commitment to detail SYMJEPI to allergists and high-prescribing physicians will be a catalyst to bring broad awareness and usage within the billion plus dollar anaphylaxis market."

    "Also, during the last quarter we acquired rights to develop a novel drug compound, Tempol, for certain indications including COVID-19 infections. We believe Tempol could be a powerful therapeutic agent in combating COVID-19 and are committed to working with the FDA and other agencies with a goal to begin testing Tempol in patients as soon as practicable.  I believe there are a number of exciting near-term milestones for Adamis and I am very excited about the second half of 2020 and beyond."

    Product Updates

    SYMJEPI (epinephrine) Injection

    On July 1, 2020, Adamis' new commercial partner, USWM began promoting SYMJEPI ® (epinephrine) Injection 0.3mg and SYMJEPI ® (epinephrine) Injection 0.15mg products through its field sales force in the U.S.   USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians.

    In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and during the last quarter, through its Australian partner, Emerge Health, Adamis submitted a regulatory dossier to seek clearance to begin marketing both SYMJEPI products in the Australian market.

    ZIMHI (naloxone) Injection

    On May 11, 2020, Adamis 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 agreement, USWM 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 FDA, 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.  The FDA has provided a target action date (PDUFA) of November 15, 2020 with respect to the company's resubmitted New Drug Application (NDA) relating to ZIMHI.

    Tempol

    In June, the company entered into a license agreement with Matrix Biomed, Inc. (Matrix)  to license rights under patents, patent applications and related know-how of Matrix related to Tempol, an investigational drug in the fields of COVID-19 infection, asthma, respiratory syncytial virus influenza infection and as a therapeutic for reducing radiation-induced dermatitis in patients undergoing treatment for cancer.

    Since licensing this product, the company has submitted to the FDA a Pre-Investigational New Drug (IND) package, and the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled Phase II study examining Tempol in COVID-19 patients.  The company's goal is to apply for and obtain funding from certain government agencies and programs to enable the necessary trials to determine the efficacy of Tempol as a therapeutic treatment for COVID-19.

    Drug Outsourcing Facility

    Year to date, sterile and non-sterile revenues from the company's wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the novel coronavirus outbreak.  Revenues decreased by approximately 19% year to date compared to the same period in the prior year. 

    Second Quarter Financial Results

    Year to date revenues were approximately $8.6 million and $10.7 million for the six months ended June 30, 2020 and 2019, respectively. The COVID-19 pandemic has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians' offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC's customers for certain of USC's products.  Revenues for the first six months of 2020 decreased by approximately 20% at the end of June of 2020 compared to the comparable period of 2019.  

    Selling, general and administrative expenses ("SG&A") for the six months ended June 30, 2020 and 2019 were approximately $11.7 million and $15.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses and to a lesser extent by decreases in patent, consulting, outside services, professional fees, depreciation and other related expenses. 

    Research and development expenses were approximately $5.1 million and $5.0 million for the six months ended June 30, 2020 and 2019, respectively.

    Cash and equivalents at the end of the second quarter was approximately $7.9 million.

    Targeted Milestones  

    • Work with USWM to finalize transition of SYMJEPI commercial responsibility from Sandoz;
    • FDA approval and U.S. commercial launch of ZIMHI;
    • Return USC division back to pre-COVID-19 levels;
    • Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
    • Begin Phase 2 trial for Tempol in COVID-19 patients

    Conference Call

    Adamis will host a conference call and live webcast on Thursday, August 20, 2020 at 1:30 pm Pacific Time to discuss its financial and operating results for the second 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: 13708688

    Webcast: http://public.viavid.com/index.php?id=141302 

    In addition, a telephone playback of the call will be available after approximately 4:30 pm PT on August 20, 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 13708688.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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 with a target action date of November 15, 2020.  Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD.  The company's subsidiary, U.S. 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.

    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 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; the company's beliefs concerning the timing or outcome of discussions with the FDA and other agencies concerning the company's pre-IND package, and any IND that the company may submit to the FDA, relating to a proposed Phase II study examining Tempol in COVID-19 patients, concerning the timing or outcome of discussions with government agencies or others regarding the design and funding for trials relating to use of Tempol as a therapeutic treatment for COVID-19, or the timing or outcome of any such trials; 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

    Primary Logo

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  21. SAN DIEGO, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today that in response to Adamis' Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled trial. The FDA's response now allows Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.

    Dr. Dennis J. Carlo, President and CEO of Adamis stated: "After submitting an extensive clinical protocol entitled ‘Preventing COVID-19…

    SAN DIEGO, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today that in response to Adamis' Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled trial. The FDA's response now allows Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.

    Dr. Dennis J. Carlo, President and CEO of Adamis stated: "After submitting an extensive clinical protocol entitled ‘Preventing COVID-19 Related Hospitalizations in Subjects with COVID-19 Infection', we received thoughtful and comprehensive guidance from the FDA. We believe that Tempol's unique antioxidant and anti-inflammatory activity, and its ability to inhibit the "cytokine storm" in pertinent animal models, makes it a strong candidate for the potential treatment of COVID-19. By protecting healthy cells, Tempol may delay or prevent disease progression and hospitialization."

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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 with a target action date of November 15, 2020. In May 2020, the Company announced a partnership with US WorldMeds for the commercialization of SYMJEPI and, if approved by the FDA, ZIMHI. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary 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 or product candidates described in the press release; the timing of commencement of completion of any clinical trials relating to Tempol; the results of any future clinical trials that the company or may conduct relating to Tempol; the company's ability to apply and obtain government or other funding for clinical trials relating to Tempol or the timing or amount of any such funding; the company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; 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 outcome of our submission of an IND relating to a clinical trial for Tempol, regarding the timing or the outcome of our applications for government or other funding for clinical trials relating to Tempol; concerning the timing or outcome of any such clinical trials; or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. 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 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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  22. SAN DIEGO, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that it has received a letter from the NASDAQ Listing Qualifications Staff ("Nasdaq") notifying the company that as a result of the closing bid price of the company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, the company has regained compliance with Nasdaq's minimum bid price requirement and the matter is now closed.

    Last year Adamis was notified by Nasdaq that it was not in compliance with the minimum bid price rule because the closing bid price of the company's common stock had closed below $1.00 per share for 30 consecutive business days, which is the minimum required closing…

    SAN DIEGO, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that it has received a letter from the NASDAQ Listing Qualifications Staff ("Nasdaq") notifying the company that as a result of the closing bid price of the company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, the company has regained compliance with Nasdaq's minimum bid price requirement and the matter is now closed.

    Last year Adamis was notified by Nasdaq that it was not in compliance with the minimum bid price rule because the closing bid price of the company's common stock had closed below $1.00 per share for 30 consecutive business days, which is the minimum required closing bid price for continued listing on the Nasdaq Capital Market pursuant to Marketplace Rule 5550(a)(2).  The company received additional communications from Nasdaq on April 14th and April 21st indicating that ultimately extended the deadline to regain compliance to December 21, 2020.  From July 22, 2020 to August 4, 2020, the company's closing bid price for ADMP has been at $1.00 per share or greater.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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 with a target action date of November 15, 2020.  Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD.  The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, and surgery centers throughout most of the United States.

    Contact Adamis:

    Mark Flather

    Senior Director, Investor Relations

    & Corporate Communications

    (858) 412-7951

    Primary Logo

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  23. 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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  24. 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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  25. 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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  26. 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


    Primary Logo

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  27. 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

    Primary Logo

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  28. SAN DIEGO, May 15, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call 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. The company's press release concerning its first quarter 2020 financial results will be available after 1:00 p.m. Pacific Time on May 18, 2020, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the first quarter ended March 31, 2020, on that date. 

    Event: Adamis Pharmaceuticals First Quarter 2020 Conference Call…

    SAN DIEGO, May 15, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call 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. The company's press release concerning its first quarter 2020 financial results will be available after 1:00 p.m. Pacific Time on May 18, 2020, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the first quarter ended March 31, 2020, on that date. 

    Event: Adamis Pharmaceuticals First Quarter 2020 Conference Call
    Date: Monday, May 18, 2020
    Time: 2:00 pm PT (5:00 pm ET)
    US Dial-in (Toll Free): 1-877-423-9813
    TOLL/International Dial-in: 1-201-689-8573
    Conference ID: 13703885

    Dr. Dennis J. Carlo, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during this quarter and certain target milestones and goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

    A live audio webcast of the conference call will also be available via this link – http://public.viavid.com/index.php?id=139872. Participants should access this webcast site 10 minutes before the start of the call. 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

    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. In July 2019, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S. 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.

    Contact

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

    Primary Logo

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  29. SAN DIEGO, May 11, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced it is reacquiring from Sandoz Inc. the rights to its SYMJEPI ® (epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection 0.15mg products currently marketed and available in the United States.  Adamis has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the United States commercial rights for the SYMJEPI products, as well as its ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

    Adamis and Sandoz have entered into an agreement providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights of the SYMJEPI products…

    SAN DIEGO, May 11, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced it is reacquiring from Sandoz Inc. the rights to its SYMJEPI ® (epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection 0.15mg products currently marketed and available in the United States.  Adamis has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the United States commercial rights for the SYMJEPI products, as well as its ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

    Adamis and Sandoz have entered into an agreement providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights of the SYMJEPI products, 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.  As part of the termination agreement, Sandoz will continue to support the products in the U.S. under the existing commercialization agreement through the end of the transition period to help minimize any potential impact to patients and customers.

    Under the terms of the Adamis/US WorldMeds agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz' 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 US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.

    Adamis will be responsible for supplying the products to US WorldMeds at a supply price based on Adamis' direct product costs.  Adamis will retain rights to commercialize the products 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 to be filed by the company with the Securities and Exchange Commission.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are pleased Sandoz is willing to assist us through this transition and we are very excited about working with US WorldMeds. They have a proven track-record of commercializing pharmaceutical products and have a First-in-Class and only FDA-approved product, LUCEMYRA® (lofexidine), for the treatment of withdrawal symptoms associated with abrupt opioid discontinuation.  We believe US WorldMeds' existing infrastructure and current sales force positions it well to take over the marketing and distribution of our SYMJEPI products and, after receiving FDA approval, quickly and effectively launching our ZIMHI product.  We view this partnership as a synergistic fit that has the potential to maximize the value of the Products and create immediate lasting value to both shareholders and patients."

    P. Breckinridge Jones, Sr., CEO of US WorldMeds, added, "We are very excited to begin commercializing Adamis' SYMJEPI epinephrine products, and look forward to launching ZIMHI (naloxone) following its approval.  We believe SYMJEPI represents a meaningful new alternative in the epinephrine market that will benefit from our enhanced focus.  Our strong presence in the opioid dependence market made us keenly aware of the growing need for repeat dosing of the currently approved naloxone products to combat the more powerful opioids in the market today.  So, when we learned Adamis was developing a higher dose naloxone product, we knew it would be a perfect companion product for LUCEMYRA.  We are confident we can leverage our existing commercial infrastructure to speed the uptake and maximize the impact of ZIMHI.  I consider ZIMHI and LUCEMYRA a one-two punch that can strike a powerful blow in the fight against opioid overdoses and the management of withdrawal symptoms, and ultimately make a positive impact on the overall opioid epidemic.  US WorldMeds expects to be in position to launch ZIMHI shortly after approval and delivery of product from Adamis."

    As a consequence of the above agreements, Adamis has filed or will file a Form 12b-25 with the Securities and Exchange Commission to give the company additional time to prepare and file its quarterly report on Form 10-Q for the period ended March 31, 2020, to assess and reflect this subsequent event and its impact in the Form 10-Q.  The company expects to file its Form 10-Q within the five additional days provided for by Rule 12b-25.

    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 announced that it had licensed commercial rights for the US to Sandoz.  Please refer to www.SYMJEPI.com for additional product information.

    About the ZIMHI Product
    ZIMHI is a high-dose naloxone injection product candidate that is intended for the emergency treatment of opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric patients.  It is intended for immediate administration in settings where opioids may be present and is not a substitute for emergency medical care.  Naloxone is an opioid antagonist, which is generally considered the drug of choice for immediate administration for opioid overdose, and works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.  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.

    About US WorldMeds and LUCEMYRA®
    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, hemophilia, malignant hyperthermia, and CNS.  More information on US WorldMeds can be found at USWorldMeds.com.  LUCEMYRA® (lofexidine) is the first and only FDA-approved, non-opioid, non-addictive treatment for relief of multiple symptoms of opioid withdrawal associated with abrupt opioid discontinuation.  More information on LUCEMYRA, including prescribing and safety information, can be found at Lucemyra.com.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both SYMJEPI products were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product candidate, Adamis is developing other products, including 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 patients, animals, 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 ability of the parties to negotiate and enter into a transition services agreement and the termination of the company's existing commercialization agreement with Sandoz; the timing and outcome of commercialization efforts by US WorldMeds regarding the SYMJEPI and ZIMHI products; the timing of the company's resubmission to the FDA of its New Drug Application ("NDA") relating to its ZIMHI product candidate; the timing or outcome of the FDA's review of the company's resubmitted NDA relating to its ZIMHI product candidate; the company's beliefs concerning the size of the markets in which the products compete; the company's beliefs concerning the safety and effectiveness of its 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 is no assurance that our commercialization agreement with Sandoz will be terminated.  There is no assurance that the FDA will approve our NDA, once resubmitted, relating to our ZIMHI naloxone product candidate or that other matters or events 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, 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

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  30. SAN DIEGO, April 23, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced publication in the peer reviewed journal Molecules, "The Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement of Carfentanil in Rhesus Monkeys" (https://www.mdpi.com/1420-3049/25/6/1360). 

    Naloxone is an opioid antagonist that binds the opioid receptors in the brain (mu receptors) and displaces opioid-bound drugs thereby reversing toxicity and resuscitating an overdose victim. However, we and others believe that a higher dose of naloxone is required to resuscitate an opioid overdose caused by more potent synthetic opioids. In this study, monkeys received doses of carfentanil, a synthetic opioid 10,000 times stronger…

    SAN DIEGO, April 23, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced publication in the peer reviewed journal Molecules, "The Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement of Carfentanil in Rhesus Monkeys" (https://www.mdpi.com/1420-3049/25/6/1360). 

    Naloxone is an opioid antagonist that binds the opioid receptors in the brain (mu receptors) and displaces opioid-bound drugs thereby reversing toxicity and resuscitating an overdose victim. However, we and others believe that a higher dose of naloxone is required to resuscitate an opioid overdose caused by more potent synthetic opioids. In this study, monkeys received doses of carfentanil, a synthetic opioid 10,000 times stronger than morphine and 100 times more potent than fentanyl, followed by different doses of naloxone. The monkeys were then examined using PET (Positron Emission Tomography) imaging of the brain to observe the number of brain receptors bound with naloxone. The study found that higher doses of naloxone resulted in an increased number of naloxone-bound brain receptors, thereby lowering the number of brain receptors bound with the opioid. A higher level of naloxone, similar to levels produced by Adamis' ZIMHI™ product candidate, displaced more carfentanil bound to receptors compared to lower naloxone levels typically observed with current lower dose marketed naloxone products. The authors concluded that "the results suggest that higher doses of IM naloxone result in higher receptor occupancy and could be useful in combating overdoses resulting from potent synthetic opioids". The study was conducted by researchers at the University of Michigan and was funded by Adamis Pharmaceuticals.

    Prior to the COVID19 outbreak, accidental overdoses were already the leading cause of death among Americans under 50, and there is now concern that one indirect effect of the pandemic will be an increase in overdose deaths (https://abcnews.go.com/US/officials-worry-potential-spike-overdose-deaths-amid-covid/story?id=70149746) (https://www.politico.com/news/2020/04/10/trump-officials-health-experts-worry-coronavirus-will-set-back-opioid-fight-179257).

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis commented: "We are pleased to see these published study results support the use of a higher dose naloxone product, such as the one we are developing. We believe our ZIMHI naloxone injection could fill a void that currently exists in treating overdoses that result from more potent synthetic opioids. In the midst of the present COVID-19 pandemic, the need for a higher dose naloxone product may be greater than ever before. Adamis remains on track for re-submitting our New Drug Application for our ZIMHI product candidate in the second quarter of 2020 and is currently in late stage partnering discussions."

    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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including 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 patients, animals, 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 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. 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. 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, 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.

    Contact Adamis:

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

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  31. SAN DIEGO, April 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has increased its product mix to provide additional drugs to assist in the ongoing fight against COVID-19.  Due to this pandemic, the U.S. Food and Drug Administration (FDA) has allowed outsourcing facilities to compound certain medications that are in short supply, but not listed on FDA's Drug Shortage List.  USC has begun manufacturing a variety of these pharmaceutical products, many of which may be used to treat acutely ill COVID-19 patients.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis stated, "As the impact of this pandemic has…

    SAN DIEGO, April 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has increased its product mix to provide additional drugs to assist in the ongoing fight against COVID-19.  Due to this pandemic, the U.S. Food and Drug Administration (FDA) has allowed outsourcing facilities to compound certain medications that are in short supply, but not listed on FDA's Drug Shortage List.  USC has begun manufacturing a variety of these pharmaceutical products, many of which may be used to treat acutely ill COVID-19 patients.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis stated, "As the impact of this pandemic has grown, essential drugs needed to treat COVID-19 patients have become in short supply.  In order to assist in making some of these products available, we have expanded and re-directed some of our manufacturing efforts in order to supply these drugs to those patients in need.  We are 100% committed to do our part and assist in any way we can to help and alleviate the pain, suffering and anxiety that is occurring during these challenging times."

    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.  In July 2019, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S.  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 existence of drugs that are in short supply from time to time; 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; USC's ability to manufacture and supply products that are in short supply; the company's beliefs concerning the ability of its product candidates to compete successfully in the market; statements about strategies, objectives and future goals and achievements; 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 assurance regarding future demand for any products supplied by USC, USC's continued ability to supply such products, or any future revenues derived from sales of such products.  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.  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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  32. SAN DIEGO, April 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has shifted part of its production to provide medical-grade hand sanitizers to hospitals and health care workers to assist in the ongoing fight against COVID-19.   

    USC began manufacturing sanitizers after the Food and Drug Administration (FDA) issued guidance enabling FDA-registered outsourcing facilities, such as USC, to formulate certain alcohol-based hand sanitizer products for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.  The first batches of product will be shipped to hospitals…

    SAN DIEGO, April 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has shifted part of its production to provide medical-grade hand sanitizers to hospitals and health care workers to assist in the ongoing fight against COVID-19.   

    USC began manufacturing sanitizers after the Food and Drug Administration (FDA) issued guidance enabling FDA-registered outsourcing facilities, such as USC, to formulate certain alcohol-based hand sanitizer products for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.  The first batches of product will be shipped to hospitals in New York, which has been one of the hardest hit areas in the U.S.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis stated, "With demand for hand sanitizer currently outpacing supply, we have moved expeditiously to make these products available.  We will continue to manufacture for so long as there is a shortage."

    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.  In July 2019, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S.  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 existence of a shortage for hand sanitizer products; the extent of current and future demand for the hand sanitizer products being produced by the company's US Compounding Inc. (USC) subsidiary; the extent of the current and future supply of hand sanitizer products available in the U.S.; USC's ability to continue to manufacture and supply the hand sanitizer products; 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 future goals and achievements; 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 assurance regarding future demand for hand sanitizer products such as those supplied by USC, USC's continued ability to supply such products, any future revenues derived from sales of such products, or how long the current shortage of hand sanitizer products will continue.  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.  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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  33. SAN DIEGO, March 30, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the year ended December 31, 2019 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "In light of the recent COVID-19 outbreak and overall economic outlook, we have attempted to determine the impact of the outbreak on our present and future operations, including the impact on our suppliers, manufacturers and commercial partners. The good news is that at the present time we have not seen a material impact of COVID-19 on demand for our products, and we have not yet seen any significant negative impact on our supply chain or distribution network…

    SAN DIEGO, March 30, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the year ended December 31, 2019 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "In light of the recent COVID-19 outbreak and overall economic outlook, we have attempted to determine the impact of the outbreak on our present and future operations, including the impact on our suppliers, manufacturers and commercial partners. The good news is that at the present time we have not seen a material impact of COVID-19 on demand for our products, and we have not yet seen any significant negative impact on our supply chain or distribution network.  If the outbreak appreciably worsens and/or if governmental restrictions persist for a protracted period, that could of course affect our outlook."

    "Having said that, the outbreak and governmental mandated social distancing and sheltering in place have caused some near-term impact and disruption to our employees and daily operations.  For that reason, and to allow some time to gain additional visibility into the 2020 year, we have determined to postpone our regularly scheduled earnings conference call.  My sincere hope is that we can have a more meaningful call in the future and provide a clearer picture of the remainder of 2020 and the outlook for the company."

    "In the meantime, we remained focused on completing the additional work to allow us to supplement our NDA for our naloxone injection product (ZIMHI).  We are actively addressing the issues the FDA raised in the Complete Response Letter we received late last year. We continue to believe ZIMHI can play an important role in combating the ongoing public health crisis of opioid overdose, and we look forward to the eventual approval of ZIMHI. SYMJEPI sales continue to be far lower than we ever expected.  We are currently working with Sandoz to determine what needs to occur to accelerate its growth in the epinephrine market. Sales of pharmaceutical preparations through our US Compounding drug outsourcing facility had strong growth for 2019 versus the year prior."

    Product Updates

    SYMJEPI (epinephrine) Injection

    On January 16, 2019, we announced that Sandoz had launched SYMJEPI (epinephrine) 0.3 mg Injection in the U.S. market, initially available in the institutional setting. On July 9, 2019, we announced the full launch (institutional and retail) by Sandoz of both dose forms of the SYMJEPI injection products.

    In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories. On October 1, 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

    On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 19, 2019, Adamis provided an update indicating that it had provided responses to the comments included in the CRL and submitted them to the FDA along with a request for a meeting. On February 12, 2020, the Company had a Type A meeting with the FDA to discuss the company's response to the CRL and the process and timeline for resubmission of the NDA to the FDA. At the meeting, Adamis obtained concurrence from the agency on the information required for resubmission of the NDA.

    The company believes it can generate the additional data, and assuming successful testing, resubmit the NDA in the second quarter of 2020. The FDA expressed its intent to review the resubmission in a rapid and timely manner consistent with agency guidelines. The company continues to have discussions with potential commercial partners for ZIMHI.

    Drug Outsourcing Facility

    During the fourth quarter of 2019, the company's wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 13% in the fourth quarter compared to the same quarter in the prior year. For the year, USC increased revenues approximately 22% versus 2018. USC's increase in revenues was due to the increase in sales of USC's sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from increasing sales and marketing efforts. 

    2019 Financial Results

    Adamis total revenues increased approximately 47%, from $15.1 million to $22.1 million, for the year ended December 31, 2018 and 2019, respectively.  Total revenues increased by approximately 33%, to $5.5 million from $4.2 million fourth quarter of 2019 compared to the same period in 2018.  The increase was primarily attributable to growth in sales of USC's sterile pharmaceutical products and revenue relating to SYMJEPI.

    Selling, general and administrative expenses ("SG&A") for the years ending December 31, 2019 and 2018 were approximately $25.3 million and $26.0 million, respectively, a decrease of approximately 3%. The decrease was primarily attributable to decreases of approximately $2.1 million in compensation expenses, occupancy costs, and other related expenses. These amounts were partially offset by an increase of approximately $1.4 million attributable to increases in consulting, legal, patent, insurance, PDUFA fees, marketing and selling expenses.

    Research and development expenses were approximately $10.4 million and $18.8 million for the years ended December 31, 2019 and 2018, respectively, a decrease of approximately 45%. The decrease was primarily due to a decrease in development costs of our product candidates.

    Cash and equivalents at the end of the year was approximately $8.8 million.  In February, the Company increased its cash position by raising approximately $6.7 million before deducting the placement agent's fees and other estimated offering expenses, in an equity financing transaction.  The net loss for the year was approximately $29.3 million.

    Targeted Milestones  

    • Increasing sales of SYMJEPI in the U.S.;
    • Resubmission of New Drug Application for ZIMHI;
    • FDA approval and commercial partner for ZIMHI;
    • Following FDA approval, begin selling ZIMHI in the U.S.;
    • Increasing sales and margins at US Compounding; and
    • Completing a Phase III ulcer study in horses.

    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.  In July 2019, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S.  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 results of the company's Type A meeting with the FDA; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI or its other products or product candidates; the company's beliefs concerning the information and activities required to resubmit the ZIMHI New Drug Application (NDA) to the FDA, the timing of resubmission of the company's NDA to the FDA and the timing and outcome of the FDA's review of any resubmitted NDA relating to the ZIMHI product; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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; the company's beliefs concerning its commercialization strategies; the company's beliefs concerning the anticipated timing of any commercialization agreement or commercial launch relating to 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; anticipated dates for making regulatory filings with the FDA; 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 that the results of the additional company testing relating to ZIMHI will be successful, that the company will be able to successfully develop the additional information required for resubmission of the ZIMHI NDA, or concerning the timing of completion of testing and development of the additional information for resubmission of the NDA.  In addition, there can be no assurance that the FDA will conclude that any NDA that the company resubmits will satisfactorily respond to the matters raised in the FDA's CRL or discussed in the Type A meeting, concerning the timing of any resubmission by Adamis of the NDA, that the FDA will approve our NDA relating to our ZIMHI product, or concerning the timing of any future action by the FDA on our 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, 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 may require additional funding, and there are no assurances that such funding will be available if required.  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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  34. SAN DIEGO, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis" or the "Company") today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $6.7 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement.  The combined purchase price for one share of common stock and 0.75 warrants will be $0.58.

    Under the terms of the purchase agreement, Adamis has agreed to sell 11,600,000 shares of its common stock.  In a concurrent private placement, Adamis has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock…

    SAN DIEGO, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis" or the "Company") today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $6.7 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement.  The combined purchase price for one share of common stock and 0.75 warrants will be $0.58.

    Under the terms of the purchase agreement, Adamis has agreed to sell 11,600,000 shares of its common stock.  In a concurrent private placement, Adamis has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock.  The warrants will be exercisable commencing on the later of (i) six months from the date of issuance or (ii) the date that Adamis' stockholders approve either an increase in the number of Adamis' authorized shares of common stock or a reverse stock split, in either case in an amount sufficient to permit the exercise in full of all of the warrants, will expire on the five year anniversary of the initial exercise date and will have an exercise price of $0.70 per share.

    The gross proceeds to the Company from the registered direct offering and concurrent private placement are expected to be approximately $6.7 million before deducting the placement agents' fees and other estimated offering expenses.  The registered direct offering and concurrent private placement is expected to close on or about February 25, 2020, subject to the satisfaction of customary closing conditions.

    Maxim Group LLC is acting as the sole placement agent in connection with the offering.

    The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-226100) previously filed and declared effective by the Securities and Exchange Commission (SEC).  The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.  A prospectus supplement relating to the shares of common stock will be filed by Adamis Pharmaceuticals with the SEC.  When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product candidate, Adamis is developing other products, including 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 patients, animals, hospitals, clinics and surgery centers 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, including statements regarding the offering.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.  For example, there are risks associated with investors fulfilling their obligations to purchase the securities and Adamis' ability to satisfy its conditions to close the offering.  These forward-looking statements also are subject to risks, uncertainties and assumptions, including those detailed from time to time in the Company's filings with the SEC, and represent the Company's views only as of the date they are made and should not be relied upon as representing the Company's views as of any subsequent date.  The Company's actual results may differ materially from those contemplated by these forward-looking statements.  Except to the extent required by law, 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
    (858) 412-7951

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  35. SAN DIEGO, Feb. 19, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.

    On November 22, 2019, Adamis received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose.  On December 22, 2019, the company announced that it had provided responses to the comments raised in the CRL and had also requested a Type A meeting.  The FDA scheduled the meeting for the second week of February.  On February 12, 2020, Adamis met with the agency to discuss the CRL, Adamis' responses and to determine the best…

    SAN DIEGO, Feb. 19, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.

    On November 22, 2019, Adamis received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose.  On December 22, 2019, the company announced that it had provided responses to the comments raised in the CRL and had also requested a Type A meeting.  The FDA scheduled the meeting for the second week of February.  On February 12, 2020, Adamis met with the agency to discuss the CRL, Adamis' responses and to determine the best path forward for ZIMHI.

    At the face to face meeting, the Company obtained concurrence from the agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA.  The additional information involves extractables and leachables testing from the syringe and glassware.  In addition, the potential public health role of ZIMHI (high dose naloxone) in the current opioid epidemic was also discussed. The Company believes it can generate the additional information and resubmit the NDA early in the second quarter of 2020. The FDA expressed its intent to review the resubmission in a rapid and timely manner.  Adamis will provide the next update on the ZIMHI NDA after the resubmission is accepted.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are thankful to the Agency for expediting our meeting request and we are very pleased with the outcome of the meeting.  Most fatal drug overdoses in the U.S. are attributable to potent synthetic opioids like fentanyl.  Therefore, we believe there is an urgent need for higher dose forms of naloxone such as ZIMHI to combat the increasing potency of these opioids.  We are committed to expeditiously complete the work required to resubmit our NDA and we remain committed to bringing ZIMHI to the market."

    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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including 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 patients, animals, 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 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 Type A meeting; the results of the company's Type A meeting with the FDA and the results of that meeting; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI or its other products or product candidates; the company's beliefs concerning the information and activities required to resubmit the ZIMHI NDA to the FDA, the timing of resubmission of the company's NDA to the FDA and the timing and outcome of the FDA's review of any resubmitted NDA relating to the ZIMHI product; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product. 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 that the results of the additional company testing will be successful, that the company will be able to successfully develop the additional information required for resubmission of the NDA, or concerning the timing of completion of testing and development of the additional information for resubmission of the NDA.  In addition, there can be no assurance that the FDA will conclude that any NDA that the company resubmits will  satisfactorily respond to the matters raised in the FDA's CRL or discussed in the Type A meeting, or concerning the timing of any resubmission by Adamis of the NDA, that the FDA will approve our NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, regarding the commercialization options that the company will pursue if our NDA is approved, or that the product will be able to compete successfully in the market if approved and launched. 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. 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, 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.

    Contact Adamis:

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

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  36. SAN DIEGO, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.

    On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for Adamis' ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The company has provided responses to the comments included in the CRL and submitted these answers to the FDA this week. With the responses, the company requested a Type A meeting with the agency and is currently waiting for the FDA to respond to this request. The next update from the company on the ZIMHI NDA resubmission…

    SAN DIEGO, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.

    On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for Adamis' ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The company has provided responses to the comments included in the CRL and submitted these answers to the FDA this week. With the responses, the company requested a Type A meeting with the agency and is currently waiting for the FDA to respond to this request. The next update from the company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting occurs. At that time, the company would expect to have more information regarding the timeline for the full resubmission of the NDA back to the FDA.

    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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including 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 patients, animals, 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 its ability to satisfactorily respond to the matters raised in the FDA's Complete Response Letter (CRL); the timing of the company's requested Type A meeting to discuss the CRL with the FDA and the results of that meeting; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI or its other products or product candidates; the company's beliefs concerning the timing of resubmission of the company's New Drug Application (NDA) to the FDA and the timing and outcome of the FDA's review of any resubmitted NDA relating to the ZIMHI product; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product. 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 that the FDA will conclude that the company's submitted responses to the comments included in the CRL are satisfactory, that company will be able to satisfactorily respond to the matters raised in the FDA's CRL or concerning the timing of any resubmission by Adamis of the NDA responding to the CRL, that the FDA will approve our NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, regarding the commercialization options that the company will pursue if our NDA is approved, or that the product will be able to compete successfully in the market if approved and launched. 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. 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, 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.

    Contact Adamis:

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

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  37. SAN DIEGO, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis' ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.  The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.  

    A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  The questions…

    SAN DIEGO, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis' ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.  The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.  

    A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  The questions raised by the FDA related generally to Chemistry, Manufacturing and Controls (CMC).  The plan is to expand on the CMC testing that has already been provided to the FDA to satisfy the CRL items.   No other clinical safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolved. 

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Obviously, we are very surprised and disappointed.  With a growing number of fatal overdoses as a result of more potent opioids like fentanyl, we believe there is an obvious need for higher dose forms of naloxone and we remain committed to bringing ZIMHI to the market.  We believe the comments and recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA.  We remain committed to this product and our mission to provide physicians and patients access to a higher dose of naloxone.  We will take the Agency's suggestion and request a meeting as soon as reasonably possible to discuss our plan to resubmit the NDA."

    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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

    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 both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019.  Please refer to www.SYMJEPI.com for additional product information.  In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including 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 patients, animals, 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 its ability to satisfactorily respond to the matters raised in the FDA's CRL; the company's beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI or its other products or product candidates; the company's beliefs concerning the timing and outcome of the FDA's review of the company's New Drug Application (NDA) relating to the ZIMHI product or any resubmitted NDA; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product.  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 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, that the FDA will approve our NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, regarding the commercialization options that the company will pursue if our NDA is approved, or that the product will be able to compete successfully in the market if approved and launched. 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.  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, 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.

    Contact Adamis:

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

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  38. SAN DIEGO, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today that an article entitled "Comparative Pharmacokinetic Analysis of Community Use Naloxone Formulations for Acute Treatment of Opioid Overdose" was accepted for publication in the peer reviewed Journal of Addiction Research and Adolescent Behavior (Link to Article). 

    The article compares the pharmacokinetics of two community naloxone formulations (2mg intramuscular (IM) and NARCAN® 4mg intranasal (IN)) to Adamis' investigational drug ZIMHI (5mg IM) in healthy subjects. Overall, the systemic levels of naloxone associated with the 2mg IM and 4mg IN were similar. By comparison, the naloxone levels associated with ZIMHI are higher…

    SAN DIEGO, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today that an article entitled "Comparative Pharmacokinetic Analysis of Community Use Naloxone Formulations for Acute Treatment of Opioid Overdose" was accepted for publication in the peer reviewed Journal of Addiction Research and Adolescent Behavior (Link to Article). 

    The article compares the pharmacokinetics of two community naloxone formulations (2mg intramuscular (IM) and NARCAN® 4mg intranasal (IN)) to Adamis' investigational drug ZIMHI (5mg IM) in healthy subjects. Overall, the systemic levels of naloxone associated with the 2mg IM and 4mg IN were similar. By comparison, the naloxone levels associated with ZIMHI are higher with more rapid absorption. The authors concluded that "These results support the notion that higher doses of naloxone result in greater bioavailability, which may be required for reversal due to the more potent synthetic opioids such as fentanyl."

    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.

    According to statistics published by the Centers for Disease Control and Prevention (CDC), in 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50. The current epidemic of drug overdoses is killing people at a faster rate than the peak of the HIV epidemic. New provisional data from the CDC suggests a slight drop in overall deaths due to overdoses in 2018, but the number of deaths due to illicitly manufactured synthetic opioids, such as fentanyl, continues to rise. 

    "Rapid and higher levels of naloxone by intramuscular injection may be required for resuscitation of overdoses due to the more potent opiates such as fentanyl. Death after opioid exposure can occur within minutes. In this comparison, ZIMHI resulted in higher and more rapid levels of naloxone compared to the other marketed formulations. In addition, a recent large field trial of opioid overdoses demonstrated that intramuscular injection of naloxone was superior to intranasal administration on several important clinical outcomes (Link to Article). We believe that the higher and more rapid blood levels provided by ZIMHI intramuscular injection could provide a competitive advantage and could be part of the solution for this devastating epidemic," said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis.

    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. In July, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S. 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 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, 2018, 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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  39. SAN DIEGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the third quarter ended September 30, 2019 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM.  We believe the Sandoz team is now targeting allergists and primary care physicians with their retail launch.  A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to…

    SAN DIEGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced financial results for the third quarter ended September 30, 2019 and provided a business update.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM.  We believe the Sandoz team is now targeting allergists and primary care physicians with their retail launch.  A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to patients' homes through PillPack, an Amazon company."

    "While we are eager for sales of SYMJEPI to grow, we are also looking forward to a final decision by the FDA on ZIMHITM, our naloxone injection product candidate.  If approved, we believe our company will be very well positioned for growth in 2020 as we plan to play an important role in combating the ongoing public health crisis of opioid overdose."

    Product Updates

    SYMJEPI (epinephrine) Injection

    During the third quarter, Adamis' commercial partner, Sandoz, announced the full launch of our SYMJEPI epinephrine injection product, making both the 0.3mg and 0.15mg doses available in local pharmacies across the U.S.  Sandoz increased and continues to expand its commercial initiatives and we expect those efforts to begin translating into a steeper sales growth during the fourth quarter. 

    In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and on October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in Australia and New Zealand.

    ZIMHI (naloxone) Injection

    Since Adamis' November 4, 2019 update, the U.S. Food and Drug Administration ("FDA") continues to review the company's New Drug Application (NDA) for its ZIMHI high-dose naloxone product candidate, and as of the date of this press release the company has not received any notice of action from the FDA.  The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose.  The company believes that discussions with potential partners for ZIMHI have sufficiently progressed and that while no assurances are possible, the company expects to be able to announce a commercial partner soon after receiving clearance from the FDA.

    Drug Outsourcing Facility

    During the third quarter of 2019, the company's wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 19% in the third quarter compared to the same quarter last year and approximately 25% year-to-date versus the same nine months of 2018.  USC's increase in revenues was due to the increase in sales of USC's sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from marketing personnel efforts. 

    Third Quarter 2019 Financial Results

    Revenues increased approximately 54%, from $3.8 million to $5.9 million, for the three months ended September 30, 2018 and 2019, respectively.  Revenues increased by approximately 52%, from $10.9 million to $16.6 million for the first nine months of 2018 compared to the same period in 2019.  The increase was primarily attributable to growth in sales of USC's sterile pharmaceutical products and revenue relating to SYMJEPI.

    Selling, general and administrative expenses ("SG&A") decreased approximately 19%, from $6.5 million to $5.3 million for the three months ended September 30, 2018 and 2019, respectively. The decrease in SG&A expenses was primarily due to decreases in wages and benefits.

    Research and development expenses ("R&D") decreased approximately 15%, from $3.9 million to $3.3 million for the third quarter of 2018 compared to the same period in 2019. The decrease was primarily due to a decrease in development costs of our product candidates. We anticipate that R&D expenses will continue to decrease in the fourth quarter of 2019.

    Cash and equivalents at the end of the third quarter was approximately $12.1 million. 

    Targeted Near-Term Milestones  

    • Increasing sales of SYMJEPI in the U.S.
    • FDA approval and commercial partner for ZIMHI
    • Additional commercial partners for SYMJEPI outside of the U.S.
    • Increasing sales and margins at US Compounding

    Conference Call

    Adamis will host a conference call and live webcast today, November 12, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the third quarter 2019, as well as provide an update on business developments and activities.

    US Dial-in (Toll Free): 1-800-458-4121

    TOLL/International Dial-In: 1-323-794-2093

    Conference ID:  1103072

    Webcast:  http://public.viavid.com/index.php?id=136653

    If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on November 12, 2019.  To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 1103072.

    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.  In July, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S.  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 company's beliefs concerning the timing and outcome of the FDA's review of the company's New Drug Application (NDA) relating to the ZIMHI product; the company's beliefs concerning the timing of entering into a commercial agreement with a third party relating to ZIMHI; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product.  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 that the FDA will approve our NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, regarding the commercialization options that the company will pursue if our NDA is approved, or that the product will be able to compete successfully in the market if approved and launched.  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, or other reasons.  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.  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, 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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  40. SAN DIEGO, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call on Tuesday, November 12, 2019 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2019 as well as provide an update on business developments and activities.  The company's press release concerning its third quarter 2019 financial results will be available after 1:00 p.m. Pacific Time on November 12, 2019, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the third quarter ended September 30, 2019, on that date. 

    Event: Adamis Pharmaceuticals Third Quarter…

    SAN DIEGO, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis") announced today that it will host an investor conference call on Tuesday, November 12, 2019 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2019 as well as provide an update on business developments and activities.  The company's press release concerning its third quarter 2019 financial results will be available after 1:00 p.m. Pacific Time on November 12, 2019, on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the third quarter ended September 30, 2019, on that date. 

    Event: Adamis Pharmaceuticals Third Quarter 2019 Conference Call

    Date: Tuesday, November 12, 2019

    Time: 2:00 pm PT (5:00 pm ET)

    US Dial-in (Toll Free): 1-800-458-4121

    TOLL/International Dial-in: 1-323-794-2093

    Conference ID:  1103072

    Dr. Dennis J. Carlo, President and CEO of Adamis, will host the call along with other members of the management team.  The call is open to the public and will provide an update on recent developments, events that have taken place during this quarter and certain target milestones and goals for future periods.  Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

    A live audio webcast of the conference call will also be available via this link – http://public.viavid.com/index.php?id=136653.  Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 12, 2019.  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 1103072.

    About Adamis

    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 SYMJEPITM (epinephrine) Injection 0.3mg and SYMJEPITM (epinephrine) Injection 0.15mg products were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis.  In July, Sandoz, a division of Novartis Group, announced it had fully launched both SYMJEPI products in the U.S.  Adamis is developing additional products, including a naloxone injection product candidate, ZIMHITM, for the treatment of opioid overdose, and a dry powder inhaler product candidate for the treatment of asthma and COPD.  The company's subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs for humans and animals, and certain nonsterile drugs for use by hospitals, clinics and surgery centers throughout most of the United States.

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

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  41. SAN DIEGO, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that as of the close of business today, Adamis has not received any notice of action from the U.S. Food and Drug Administration ("FDA") on the company's New Drug Application relating to its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.  As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019.  However, 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…

    SAN DIEGO, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") today announced that as of the close of business today, Adamis has not received any notice of action from the U.S. Food and Drug Administration ("FDA") on the company's New Drug Application relating to its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.  As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019.  However, 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, or other reasons.  Adamis intends to make an announcement relating to FDA action concerning the NDA after it receives a notice of action or similar communication from the agency.

    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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

    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, and both were fully launched in the U.S. in July 2019.  Please refer to www.SYMJEPI.com for additional product information.  In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including 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 patients, animals, 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 the ZIMHI product; the company's beliefs concerning its ability to commercialize ZIMHI and its other 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 ZIMHI or its other products and product candidates; the company's beliefs concerning its commercialization strategies; and the company's beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product.  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 that the FDA will approve our NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, regarding the commercialization options that the company will pursue if our NDA is approved, or that the product will be able to compete successfully in the market if approved and launched.  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.  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, 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.

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

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  42. SAN DIEGO, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the presentation of data pertaining to its investigational high dose naloxone product (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on "Opioid Intersection". Other participants at the meeting included Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health, and Admiral Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services. The Adamis data was presented by Dr. Ronald Moss, Chief Medical Officer at Adamis.

    Naloxone…

    SAN DIEGO, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) ("Adamis") announced today the presentation of data pertaining to its investigational high dose naloxone product (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on "Opioid Intersection". Other participants at the meeting included Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health, and Admiral Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services. The Adamis data was presented by Dr. Ronald Moss, Chief Medical Officer at Adamis.

    Naloxone is an opioid antagonist that competes opioids off their receptors in the brain. Rapid and efficient reversal by naloxone is critical as brain injury and death can occur within minutes.

    Adamis presented data comparing the pharmacokinetics of ZIMHI to current doses of naloxone products (Evzio, Narcan, and generic Naloxone). ZIMHI had significantly higher and more rapid levels of naloxone in the blood compared to the other products.

    Adamis also presented data on a model that simulated various overdoses due to the more potent synthetic opioids such as fentanyl. ZIMHI was shown in the model to rapidly compete out fentanyl from the receptors in the brain while current doses took longer. The model suggested that at higher doses of fentanyl overdose, higher doses of naloxone, such as are contained in ZIMHI, can potentially result in a more rapid and successful resuscitation.

    Dr. Dennis J. Carlo, President and CEO of Adamis commented on the presentation: "We believe these data suggest that ZIMHI should be useful in the current opioid epidemic, where the more potent synthetic opioids continue to cause deaths. We are hopeful that if our ZIMHI product candidate is approved and commercialized, both patients and first responders will have access to a higher dose naloxone product, which should lead to saving more 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, and both were fully launched in the U.S. in July 2019.  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 patients, animals, 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 statements: the company's beliefs concerning the timing and outcome of the FDA's review of the company's NDA relating to its ZIMHI™ (naloxone) Injection product candidate; the data and interpretation of the data from the company's studies pertaining to the company's 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 its 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.  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.  The FDA review process is subject to a number of uncertainties.  The FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated target PDUFA 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 within the last three months of the target PDUFA date, such as submission of the results of the company's PK study, or other reasons. As a result, the dates of regulatory approval, if obtained, and commercial introduction of our product could be delayed beyond our expectations. 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, 2018, 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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  43. SAN DIEGO, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that it has entered into an exclusive distribution and commercialization agreement with Emerge Health Pty ("Emerge") to register and commercialize Adamis' SYMJEPI® (epinephrine) Injection products in Australia and New Zealand.

    Under the terms of the agreement, Adamis will provide technical support to Emerge during the registration process, which could take more than a year.  If successful, Adamis will begin supplying product to Emerge.  Emerge will be responsible for the full registration, reimbursement, sales, marketing and distribution of SYMJEPI® in Australia and New Zealand (the "Territory").  Once commercially launched, Adamis…

    SAN DIEGO, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that it has entered into an exclusive distribution and commercialization agreement with Emerge Health Pty ("Emerge") to register and commercialize Adamis' SYMJEPI® (epinephrine) Injection products in Australia and New Zealand.

    Under the terms of the agreement, Adamis will provide technical support to Emerge during the registration process, which could take more than a year.  If successful, Adamis will begin supplying product to Emerge.  Emerge will be responsible for the full registration, reimbursement, sales, marketing and distribution of SYMJEPI® in Australia and New Zealand (the "Territory").  Once commercially launched, Adamis and Emerge will equally share net profits (as defined in the agreement) generated from sales of SYMJEPI® in the Territory.  Based on its experience with the registration process in the Territory, Emerge does not anticipate that a commercial launch could occur before 2021. 

    Adamis hopes that Emerge will find a ready market for SYMJEPI® as Australia has among the highest allergy rates in the world.  A study published in 2017 in the Journal of Allergy and Clinical Immunology indicates that, in Australia, 1 in 10 infants and 1 in 20 children aged 10-14 years have food allergies.  High rates of allergies typically result in higher incidences of anaphylaxis, and Australian hospital admissions for anaphylaxis have increased five-fold in the last 20 years.  According to the Murdoch Children's Research Institute in Victoria, Australia has one of the highest rates of hospital admissions for anaphylaxis in the developed world.

    David J. Marguglio, Chief Business Officer of Adamis, stated, "We are very excited to be working with a great company like Emerge and see this as another important step toward our goal of making SYMJEPI® available to patients and caregivers around the world.  We are also pleased that our first commercial partnership for SYMJEPI® outside the United States is for a territory we feel has a heightened need of a ready supply of epinephrine injection products."

    Chris Rossidis, Co-Founder and Head of Emerge's Commercial Operations added, "The prevalence of allergies and inconsistent availability of epinephrine injection products have combined to create a public health crisis in Australia.  We hope that through our partnership with Adamis we may be able to ensure all patients have access to this important and potentially life-saving product."  

    About Anaphylaxis

    Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex.  Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The use of epinephrine injection products has grown as the risk of anaphylaxis and allergic reactions have become more widely understood.

    About Emerge Health Pty

    Emerge is an innovative, specialized pharmaceutical company focused on the marketing and sales of high quality medicines in Australia and New Zealand.  Emerge is dedicated to providing exceptional products and support to ensure they meet their customers' and partners' needs and priorities.

    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, and both were fully launched in the U.S. in July 2019.  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 patients, animals, 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 statements: the company's beliefs concerning the timing and outcome of the regulatory process in Australia and New Zealand concerning registration and approval of SYMJEPI in the Territory; the date of any commercial launch of SYMJEPI in the Territory; the ability of Emerge to successfully commercialize SYMJEPI in the Territory; the prevalence and severity of allergies in the Territory and the availability of epinephrine injection products in the Territory; 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 its 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 regulatory review process regarding SYMJEPI in Australia or New Zealand or that SYMJEPI will be registered and approved for marketing and sale in the Territory.  There can be no assurances regarding the timing of any commercial launch of SYMJEPI in the Territory, the commercial success or any such launch or the amount of net profit payments that the company could receive following any such launch.  The dates of regulatory approval, if obtained, and commercial introduction of SYMJEPI in the Territory could be delayed beyond our expectations. 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, 2018, 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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  44. SAN DIEGO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that Dr. Ronald Moss, Chief Medical Officer, will be presenting data on October 4, 2019, pertaining to the company's investigational high dose naloxone product candidate (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on "Opioid Intersection". Other participants at the meeting will be public health experts including Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), and Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health.

    Naloxone…

    SAN DIEGO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today that Dr. Ronald Moss, Chief Medical Officer, will be presenting data on October 4, 2019, pertaining to the company's investigational high dose naloxone product candidate (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on "Opioid Intersection". Other participants at the meeting will be public health experts including Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), and Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health.

    Naloxone is an opioid antagonist that competes opioids off their receptors in the brain. Rapid and efficient reversal by naloxone is critical as brain injury and death can occur within minutes.

    Dr. Moss will be presenting data comparing the pharmacokinetics of ZIMHI to current doses of commercial naloxone products (Evzio, Narcan, and generic Naloxone).  Additionally, Dr. Moss will be presenting data on a model that simulates drug overdoses due to the more potent synthetic opioids such as fentanyl.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We believe the data suggests that ZIMHI should play a significant and primary role in the treatment of opioid overdose, especially where the more potent synthetic opioids are involved.  We are hopeful that with the commercialization of ZIMHI, both patients and first responders will have access to a higher dose naloxone 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, and both were fully launched in the U.S. in July 2019.  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 patients, animals, 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 statements: the company's beliefs concerning the timing and outcome of the FDA's review of the company's NDA relating to its ZIMHITM (naloxone) Injection product candidate; the data and interpretation of the data from the company's studies pertaining to the company's 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 its 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.  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.  The FDA review process is subject to a number of uncertainties.  The FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated target PDUFA 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 within the last three months of the target PDUFA date, such as submission of the results of the company's PK study, or other reasons. As a result, the dates of regulatory approval, if obtained, and commercial introduction of our product could be delayed beyond our expectations. 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, 2018, 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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  45. SAN DIEGO, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today the completion of pharmacokinetic (PK) studies comparing its naloxone injection product candidate, ZIMHITM (naloxone) Injection, to a generic naloxone comparator.

    In June, the Company amended the New Drug Application (NDA) for ZIMHI to remove any reference to EVZIO® and withdrew the Paragraph IV certification relating to that product.  On August 8, the Company announced it was conducting additional PK studies comparing ZIMHI and a relevant comparator. The data for the PK study has been recorded and is complete.  The data base will be forwarded to the FDA this month.  As previously announced, the PDUFA date remains October 31, 2019…

    SAN DIEGO, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced today the completion of pharmacokinetic (PK) studies comparing its naloxone injection product candidate, ZIMHITM (naloxone) Injection, to a generic naloxone comparator.

    In June, the Company amended the New Drug Application (NDA) for ZIMHI to remove any reference to EVZIO® and withdrew the Paragraph IV certification relating to that product.  On August 8, the Company announced it was conducting additional PK studies comparing ZIMHI and a relevant comparator. The data for the PK study has been recorded and is complete.  The data base will be forwarded to the FDA this month.  As previously announced, the PDUFA date remains October 31, 2019.

    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, and both were fully launched in the U.S. in July 2019.  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 patients, animals, 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 statements: the company's beliefs concerning the timing and outcome of the FDA's review of the company's NDA relating to its ZIMHITM (naloxone) Injection 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 its 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.  There can be no assurances that the FDA 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.  The FDA review process is subject to a number of uncertainties.  The FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated target PDUFA 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 within the last three months of the target PDUFA date, such as submission of the results of the company's PK study, or other reasons. As a result, the dates of regulatory approval, if obtained, and commercial introduction of our product could be delayed beyond our expectations. 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, 2018, 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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  46. SAN DIEGO, Aug. 28, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided a progress report and marketing update on the U.S. launch of SYMJEPITM (epinephrine) 0.3 mg and 0.15 mg Injections.

    During this back-to-school season, there is a heightened awareness of the shortage for epinephrine auto injectors. Adamis, in collaboration with Sandoz, Inc., hopes to alleviate some of the demand with their recently launched both doses of SYMJEPI into the hospital and retail market. Due to their efforts to broaden access for patients, nearly 90% of commercially insured people in the U.S. now have access to SYMJEPI through National and Regional Payers.

    To ensure access for U.S. military personnel, retirees, and their dependents…

    SAN DIEGO, Aug. 28, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided a progress report and marketing update on the U.S. launch of SYMJEPITM (epinephrine) 0.3 mg and 0.15 mg Injections.

    During this back-to-school season, there is a heightened awareness of the shortage for epinephrine auto injectors. Adamis, in collaboration with Sandoz, Inc., hopes to alleviate some of the demand with their recently launched both doses of SYMJEPI into the hospital and retail market. Due to their efforts to broaden access for patients, nearly 90% of commercially insured people in the U.S. now have access to SYMJEPI through National and Regional Payers.

    To ensure access for U.S. military personnel, retirees, and their dependents, SYMJEPI has been added to the Department of Defense's ("DOD") Uniform Formulary for Tricare, now effective as of early August. Public records indicate the DOD's budget for epinephrine in fiscal 2016 was more than $57 million.

    SYMJEPI was featured in an online USA Today article on August 14 in USA Today, "How to protect your children from life-threatening allergies." Other marketing efforts underway include public relations programs, product donations to underserved US patients, patient advocacy efforts, personal selling, and raising awareness through scientific and consumer journal advertising. For a more detailed list of recent SYMJEPI press and scientific articles, please visit Adamis' website here.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We are excited to see the progress being made regarding the retail launch of SYMJEPI. Through our collaboration, we are increasing marketing efforts through several channels and these formulary additions should provide a broad foundation for growth of this product during a time of shortages of other products in this space. We look forward to seeing continued momentum through the end of the year and beyond."

    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, and both were fully launched in the U.S. in July 2019. 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 patients, animals, hospitals, clinics and surgery centers throughout most of the United States.

    Important Safety Information

    CONTRAINDICATIONS
    None

    WARNINGS AND PRECAUTIONS

    • You should get emergency medical care right away after using the product.
    • You may need to use a second SYMJEPI (epinephrine) injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
    • Symjepi should only be injected into the middle of your outer thigh (upper leg) with the needle facing downwards. Never inject into any other part of the body.  If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. Symjepi can be injected through your clothing if needed.
    • The needle cap on the SYMJEPI prefilled syringe helps to prevent needle sticks and accidental injection of epinephrine. Do not remove the needle cap until you are ready to use it. 
    • Never put your thumb, fingers, or hand over the exposed needle.
    • If an accidental injection happens, get medical help right away.
    • Do not drop the carrier case or SYMJEPI prefilled syringe. If the carrier case or prefilled syringe is dropped, check for damage and leakage. Dispose of the prefilled syringe and carrier case, and replace if damage or leakage is noticed or suspected.
    • Do not place patient information or any other foreign objects in the carrier case with the prefilled syringe, as this may prevent you from removing the prefilled syringe for use.
    • If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during injection.
    • Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:
      • have heart problems or high blood pressure.
      • have diabetes.
      • have thyroid problems.
      • have asthma.
      • have a history of depression.
      • have Parkinson's disease.
      • are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
      • are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

    ADVERSE REACTIONS
    Symjepi may cause serious side effects.

    • Rarely, patients who have used SYMJEPI may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
      • redness that does not go away
      • swelling
      • tenderness
      • the area feels warm to the touch
    • Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during the injection.
    • If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your SYMJEPI. Talk to your healthcare provider about all your medical conditions.

    Common side effects of SYMJEPI include:

    • fast, irregular or "pounding" heartbeat
    • sweating
    • headache
    • weakness
    • shakiness
    • paleness
    • feelings of over excitement, nervousness or anxiety
    • dizziness
    • nausea and vomiting
    • breathing problems

    These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.

    DRUG INTERACTIONS

    • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Tell your healthcare provider of all known allergies.
    • Especially tell your healthcare provider if you take certain asthma medicines.
    • SYMJEPI and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.
    • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    For full prescribing and safety information, please click on this link.

    You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    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 statements: the company's beliefs concerning the commercial success of its SYMJEPI products; the company's beliefs concerning the marketing and commercialization efforts of Sandoz relating to the SYMJEPI products; the company's ability to provide an adequate supply of product; the company's beliefs concerning the resources and capabilities that are required to provide access to its SYMJEPI product; 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 its products and product candidates; guidance regarding future periods; 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 future commercial success of SYMJEPI.  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, 2018, 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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  47. SAN DIEGO, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the appointment of Howard C. Birndorf and Roshawn Blunt to its Board of Directors.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are very excited to bring on these two new members with such strong credentials to Adamis' Board.  They bring tremendous leadership, creativity, success, reimbursement, market access, compliance, and healthcare innovation to the company.  Together, they provide us with years of experience and expertise that will help enable us to move into the next stages of corporate development.  Their proven track record, knowledge and relationships in the pharmaceuticals area will be an asset to the company…

    SAN DIEGO, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the appointment of Howard C. Birndorf and Roshawn Blunt to its Board of Directors.

    Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are very excited to bring on these two new members with such strong credentials to Adamis' Board.  They bring tremendous leadership, creativity, success, reimbursement, market access, compliance, and healthcare innovation to the company.  Together, they provide us with years of experience and expertise that will help enable us to move into the next stages of corporate development.  Their proven track record, knowledge and relationships in the pharmaceuticals area will be an asset to the company as we continue our transition from a development company into a company with several sources of revenues."

    The new board additions include:

    Howard C. Birndorf:  Mr. Birndorf is a biotechnology entrepreneur and one of the founders of the biotech industry in San Diego, California. In 1978, Birndorf co-founded San Diego's first biotech, the monoclonal antibody company Hybritech.  The company was subsequently bought by Eli Lilly and Company in 1986, and Mr. Birndorf went on to found or co-found a number of other successful companies including Gen-Probe, IDEC Pharmaceuticals (which merged with Biogen to form Biogen-Idec), and Ligand Pharmaceuticals.  Birndorf was also involved in the formation of Gensia (Sicor) and was a director of Neurocrine Biosciences.  He was the founder and co-chair of the Coalition for 21st Century Medicine and was co-founder, Chairman and CEO of Nanogen, Inc.  Birndorf received his B.A. in Biology from Oakland University, an M.S. in Biochemistry from Wayne State University, and has received honorary Doctor of Science degrees from Oakland University and Wayne State University.

    Roshawn Blunt:  Ms. Blunt has more than 20 years of experience in the biopharmaceutical and medical device industries.  Currently, Ms. Blunt founded and is managing director of 1798 Consultants, which is a national healthcare consulting firm focused on educating and developing strategies for clients to address healthcare compliance, reimbursement, health policy and patient access issues.  She began her pharmaceutical career at The Boston Consulting Group, working primarily on cases in the healthcare industry.  She has held a variety of strategic reimbursement and commercialization positions of increasing importance at Amgen, Inc. including involvement in the marketing of Aranesp and acting as global government affairs director in the company's Washington DC office. Ms. Blunt was also the first global director of health economics and reimbursement for Biosense Webster, a Johnson & Johnson company.  Prior to starting 1798 Consultants, she was vice president of strategy, planning, and communication at Long Beach Memorial Center and Miller Children's Hospital.  Ms. Blunt graduated from Princeton University, where she received her A.B. from the Woodrow Wilson School of International and Public Policy.  She earned her M.B.A. from Kellogg School of Management at Northwestern University.

    These two new independent board members have replaced Robert B. Rothermel, who has resigned from the Board for personal reasons.  Additional information concerning his resignation is contained in a report on Report on Form 8-K that the Company will file with the Securities and Exchange Commission.

    Richard C. Williams, Chairman, added, "The Company would like to thank Robert B. Rothermel for his contributions in helping grow the company and wish him the very best in his future endeavors."

    About Adamis Pharmaceuticals Corporation

    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.  In July, Sandoz, a division of Novartis Group, announced it had fully launched both in the U.S.  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 patients, animals, hospitals, clinics and surgery centers throughout most of the United States.

    Contact:

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

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