On March 15, 2018 Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) reported that investors with an update concerning certain accomplishments for 2017 and accomplishments and goals for 2018 (Press release, , 15 15, 2018, view-source:View Source [SID1234524824]).
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2017 Highlights
As reflected in the company’s annual report on Form 10-K for year ending December 31, 2017, recently filed with the Securities and Exchange Commission, some of the company’s accomplishments during 2017 included the following:
New Drug Application ("NDA") for Symjepi TM (epinephrine) Injection 0.3mg product, was approved by the U.S. Food and Drug Administration ("FDA") for the treatment of allergic reactions (Type I) including anaphylaxis.
Supplemental New Drug Application ("sNDA") was submitted for the lower dose Symjepi TM (epinephrine) Injection 0.15mg product for patients weighing 33-65 pounds.
Investigational New Drug ("IND") application was submitted to the FDA for a Naloxone injection product candidate, which uses the same approved injection device, for the treatment of opioid overdose.
The number of outstanding warrants was reduced through exercise transactions, which the company believes improved its balance sheet.
U.S. Compounding, Inc. subsidiary applied for a patent and began marketing a novel equine ulcer product for which the company believes there could be a significant market.
Early 2018 Highlights
Some of the company’s accomplishments during 2018 include the following:
In January, an IND application was submitted to the FDA for a beclomethasone HFA (APC-1000) product candidate and in February, the company received approval from the FDA to proceed with Phase 3 clinical studies.
In February, Adamis received correspondence from the FDA indicating that the agency had determined that the company’s sNDA for Symjepi (epinephrine) Injection 0.15mg was sufficiently complete to permit a substantive review and indicated that no potential review issues were identified as of the date of the agency’s communication.
In March, Adamis presented human factors data for Symjepi at the American Academy of Allergy Asthma and Immunology joint congress with the World Allergy Organization, and another human factors study was published in a peer-reviewed journal.
More on APC-1000
After the IND submission to the FDA, Adamis has recently received approval by the FDA to proceed to pivotal Phase 3 studies of APC-1000 in asthmatics. APC-1000 consists of a metered dose inhaler device containing an HFA (hydrofluoroalkane) inhaled corticosteroid called Beclomethasone, intended for the treatment of asthma. An ideal inhaled corticosteroid provides adequate lung exposure with limited systemic absorption of the drug. APC-1000 is being developed with the goal of demonstrating efficacy (lung function) and lower systemic absorption, thereby differentiating it from the current market leading inhaled corticosteroids. Following commencement of the studies, each asthmatic patient will be enrolled in the study for twelve weeks.
Asthma causes recurring periods of wheezing, chest tightness, shortness of breath, and cough. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than an estimated 25 million people are known to have asthma. Based on industry sources, we estimate that the annual global sales of prescription steroid HFA and similar products are approximately $3 billion, of which we intend to target a smaller niche.
Inhaled corticosteroids play a major role in reducing the morbidity and mortality from asthma and also reduce the need for oral corticosteroids and their related systemic toxicity risks. According to the Expert Panel Report-3 on the Guidelines for the Diagnosis and Management of Asthma, inhaled corticosteroids, such as Beclomethasone, are recommended for all stages of persistent asthma in adults and children. However, inhaled corticosteroids are also known to have local and systemic adverse effects. The goal of the Phase 3 study of APC-1000 is mainly to demonstrate efficacy, but in addition, show an improved safety profile for asthmatic patients.
Dr. Carlo, commenting on the Phase 3 clinical studies of APC-1000, said, "We are pleased with the news of receiving approval to proceed to pivotal Phase 3 studies of APC-1000 by the FDA. We will continue to work with them and seek their guidance on the commercialization of what we believe is a needed product." Dr. Ronald Moss, Chief Medical Officer of Adamis, added, "Our goal is to initiate the Phase 3 studies as soon as reasonably possible, during 2018. Having a cost-effective inhaled corticosteroid with a good safety profile would, we believe, greatly benefit asthmatic patients."
Future Milestones
Some of the company’s goals for the 2018 year include the following:
Finalizing and announcing the commercialization strategy for Symjepi (epinephrine) Injection 0.3mg;
FDA approval for Symjepi TM (epinephrine) Injection 0.15mg;
Initiate pivotal Phase 3 studies of APC-1000 in asthmatics;
Complete a "proof of concept" study with dry powder inhaler platform using fluticasone;
Filing an NDA for Naloxone injection;
Increase sales of compounded medications from our U.S. Compounding, Inc. subsidiary by at least 30%.
Dr. Carlo continued, "We remain committed to bringing Symjepi TM to market and are pleased with recent developments regarding our discussions with potential commercialization partners since our last press release pertaining to this topic. Once the commercial strategy is finalized, our focus will be advancing our other product candidates with the objective of increasing shareholder value. The entire Adamis team is working hard to achieve these goals during 2018."