Adamis Pharmaceuticals Corporation operates as a pharmaceutical company that focuses on combining specialty pharmaceuticals and biotechnology to provide medicines for patients and physicians. The company focuses on specialty pharmaceutical products. It is developing various products in the allergy and respiratory markets, including one utilizing a dry powder inhaler (DPI) technology. The company also has various biotechnology product candidates and technologies, including therapeutic vaccine and cancer product candidates and technologies intended to treat patients with unmet medical needs in the global cancer market. Anaphylaxis, Epinephrine Pre-Filled Syringe (PFS) The company's product candidate, the Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe, or the Epinephrine PFS, is a PFS designed to deliver a premeasured 0.3 mg dose of epinephrine for the treatment of anaphylaxis. APC-5000 DPI The Advair Diskus is a DPI product that combines fluticasone propionate, or fluticasone and salmeterol xinafoate, or salmeterol. Additional Allergy Products, APC-1000 and APC-2000 The company has two additional product candidates in its allergy and respiratory product pipeline. Its APC-1000 product candidate is a steroid hydrofluoroalkane metered dose inhaler product, for asthma and chronic obstructive pulmonary disease (COPD). Its product candidates, if developed and approved for marketing, would target a small niche within the larger market for respiratory products. 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 technology relates to a novel cell-based vaccine product candidate for cancer, tentatively named TeloB-VAX. APC-100 In animal studies, APC-100 demonstrated anti-androgenic and anti-inflammatory activities against prostate tumors growing in animal models. APC-100 has demonstrated desirable pharmacological characteristics as an oral or injectable anti-inflammatory and anti-androgenic drug candidate with multiple mechanisms of action. APC-200 is a drug candidate for both castrate-sensitive and castrate resistant prostate cancer. APC-200 blocks androgen-induced hydrogen peroxide production and inflammation and inhibits mouse prostate cancer. It inhibited oxidase mediated high rates of hydrogen peroxide production in vivo and delayed prostate cancer progression and death in the standard mouse prostate cancer model. APC-300 is a multi-targeted small molecule therapeutic drug that has the potential to demonstrate anti-inflammatory, pro-apoptotic anti-cancer activities for prostate cancer patients, including men with advanced metastatic castrate resistance prostate cancer. It materially decreased tumor volumes and suppressed local metastasis in human to mouse xenograft models, where malignant human prostate, pancreas, or melanoma tumor tissue was grafted onto athymic immunosuppressed experimental mice. Other Technologies Somatic Transgene Immunization (STI) Technology In addition, the company has licensed patented vaccine technology that has the potential to provide protection against various viral infectious agents. Savvy/C31G The company also has a microbicide product candidate, named Savvy (C31G). In 2010, the company announced the completion of a Phase 3 contraceptive trial of C31G. The C31G product candidate is held by the company’s Biosyn, Inc. subsidiary. Research and Development For the year ended December 31, 2015, the company spent approximately $4.8 million on all research and development activities. Sales and Marketing The company is developing its sales and marketing infrastructure, including retaining employees and entering into arrangements with third parties for additional sales and marketing support, and undertaking other related activities in anticipation of obtaining the U.S. Food and Drug Administration approval of its new drug applications relating to its Epinephrine PFS product for treating anaphylaxis. Intellectual Property As of February 5, 2016, the company had 10 issued patents in the United States and 10 pending applications, 1 of which has been allowed; 8 issued and 19 pending foreign patent applications relating to Epinephrine Injection, APC 5000 DPI and C31G. The issued patents and allowed patents applications expire between 2017 and 2035, not taking into account any potential patent-term extensions that might be available in the future. The company is the licensee of other patents under its various licensing agreements relating to APC 100, APC 200, APC 300, Telomerase and STI. Government Regulation The company is subject to other federal, state and local laws of general applicability, such as laws regulating working conditions, and various federal, state and local environmental protection laws and regulations, including laws, such as 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, among other things, 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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