As reflected in the company’s annual report on Form 10-K for year ending
- 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
FDAfor 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
FDAfor a beclomethasone HFA (APC-1000) product candidate and in February, the company received approval from the FDAto proceed with Phase 3 clinical studies.
- In February, Adamis received correspondence from the
FDAindicating 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 Immunologyjoint 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
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
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
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;
FDAapproval 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.”
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 timing and outcome of finalizing the commercialization arrangements and strategy for its Symjepi ™ (epinephrine) Injection 0.3mg product; statements about strategies, objectives and our future goals and achievements; the company’s ability to commercialize its product and product candidates; 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; expectations and goals for future growth; current or planned clinical trials or research and development activities; anticipated commencement and completion dates for clinical trials; product development timelines; anticipated dates for commercial introduction of products; guidance regarding future periods; 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 results of studies relating to Symjepi and user perceptions of Symjepi; 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. In addition, many 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
Senior Director, Investor Relations
& Corporate Communications
Source: Adamis Pharmaceuticals Corporation