Adamis Pharmaceuticals Corporation, an emerging pharmaceutical company, focuses on combining specialty pharmaceuticals and biotechnology to provide medicines for patients and physicians. The company is primarily focused on its specialty pharmaceutical products. The company is in the process of developing four products in the allergy and respiratory markets, including a dry powder inhaler technology that the company acquired from 3M Company. The company intends to pursue Section 505(b)(2) New Drug Application (NDA) regulatory approval filings with the U.S. Food and Drug Administration (FDA), whenever applicable in order to reduce the time needed to get to market and to save on costs, compared to Section 505(b)(1) NDA filings for new drug products. Epinephrine Pre-Filled Syringe The company’s most advanced product candidate, Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe, or the Epinephrine PFS, is a simple syringe designed to deliver a premeasured 0.3 mg dose of epinephrine for the treatment of anaphylaxis. The syringe is protected in a hard plastic carrying case small enough to fit, for example, in a shirt pocket. APC-5000 DPI The company entered into an agreement in 2013 with 3M Company to exclusively license and, upon final payment acquire, assets relating to 3M Company’s patented Taper dry powder inhaler, or DPI, technology under development by 3M Company for the treatment of asthma and chronic obstructive pulmonary disease. The company is in the process of preparing an investigational new drug application to be submitted to the FDA for approval to begin human testing of APC-5000 DPI. Additional Allergy Products; APC-1000 an APC-3000 Additional product candidates in its allergy and respiratory product pipeline include a steroid hydrofluoroalkane (HFA), metered dose inhaler product, referred to as APC-1000, for asthma and chronic obstructive pulmonary disease and an HFA pressurized metered dose nasal steroid for the treatment of seasonal and perennial allergic rhinitis, referred to as APC-3000. During 2011, the company entered into a strategic manufacturing, supply, and product development agreement with Beximco Pharmaceuticals Ltd. Beximco Pharmaceuticals Ltd. is a manufacturer of pharmaceutical formulations and active pharmaceutical ingredients in Bangladesh. The company intends to develop the APC-1000 product with Beximco Pharmaceuticals Ltd. TeloB-VAX In 2011, the company acquired exclusive rights to patented telomerase-based cancer vaccine technology from the Regents of the University of California and the Dana-Farber/Harvard Cancer Center. The company intends to pursue development of the TeloB-VAX technology. The technology is intended to activate the body’s natural defense machinery to stimulate an immune response against one of nature’s most common tumor markers, telomerase reverse transcriptase, or telomerase. Other In 2010, the company licensed patents and related intellectual property relating to three cancer drug candidates developed at the University of Wisconsin. These drug candidates: APC-100, -200 and -300 offers significant new treatment opportunities for prostate cancer. Strategy The company’s general business strategy is to generate revenue through launch of its allergy and respiratory products in development to generate cash flow to help fund expansion of its allergy and respiratory business, as well as support its future cancer and vaccine product development efforts. Intellectual Property The company owns the licenses of a total of 13 issued United States patents, and related U.S. applications and foreign patents and patent applications, relating to its APC-100, APC-200, APC-300, telomerase, somatic transgene immunization, APC-5000 DPI and C31G technologies and product candidates. Regulations The company, in addition to regulations enforced by the FDA, is subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other similar federal and state laws regarding, occupational safety, the use and handling of radioisotopes, environmental protection, and hazardous substance control.
adamis pharmaceuticals corp
11682 El Camino Real
San Diego, CA 92130
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