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 developing various products in the allergy and respiratory markets, including one utilizing a dry powder inhaler (DPI) technology. The company 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 The company’s most advanced product candidate, the Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe, or the Epinephrine PFS, is a pre-filled syringe designed to deliver a premeasured 0.3 mg dose of epinephrine for the treatment of anaphylaxis. The American Academy of Allergy Asthma and Immunology, defines anaphylaxis as a serious life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. APC-5000 DPI In 2013, the company acquired assets relating to 3M Company’s (3M) patented Taper DPI, technology under development by 3M for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The company intends to utilize the Taper DPI assets initially to develop a pre-metered inhaler device, referred to as APC-5000 DPI, for the treatment of asthma and COPD to deliver the same active ingredients as GlaxoSmithKline’s Advair Diskus. The Advair Diskus is a DPI, product that combines fluticasone propionate, or fluticasone and salmeterol xinafoate, or salmeterol. Fluticasone belongs to the family of medicines known as corticosteroids or steroids. In February 2015, the company announced the result of its Phase 1 pharmacokinetic study, comparing the bioavailability of its APC-5000 DPI product to GlaxoSmithKline’s Advair Diskus DPI. The company is preparing an investigational new drug application to be submitted to the U.S. Food and Drug Administration to begin human testing of APC-5000 DPI. The company intends to pursue an New Drug Application under Section 505(b)(2) to seek approval for sale in the U.S. market. The company also intends to seek to identify opportunities to market APC-5000 DPI based products outside of the U.S. Additional Allergy Products; APC-1000; APC-3000; and APC-2000: The company has various additional product candidates in its allergy and respiratory product pipeline. The company’s APC-1000 product candidate is a steroid hydrofluoroalkane (HFA), metered dose inhaler product, for asthma and COPD. In February 2015, the company announced the result of its pharmacokinetic study, comparing its beclomethasone dipropionate HFA, 80 mcg Inhalation Aerosol, product, APC-1000, with Teva Respiratory, LLC’s Qvar (Beclomethasone Dipropionate HFA, 80 mcg Inhalation Aerosol) product. The company’s APC-3000 product candidate is a HFA pressurized metered dose nasal steroid for the treatment of seasonal and perennial allergic rhinitis. Inhaled nasal steroid, or INS, products are generally sold under prescription for seasonal allergic rhinitis. The company is considering initiating a Phase 3 clinical trial for APC-3000 during the second half of 2015. The company’s third product candidate that is in development in its allergy and respiratory pipeline, APC-2000, is a HFA bronchodilator for the treatment or prevention of bronchospasm. The company’s development plans concerning its allergy and respiratory products, including APC-1000, 2000 and 3000, are affected by developments in the marketplace. The company has a strategic manufacturing, supply, and product development agreement with Beximco Pharmaceuticals Ltd., which manufactures pharmaceutical formulations and active pharmaceutical ingredients in Bangladesh. Cancer TeloB-VAX: The company owns rights to patented telomerase-based cancer vaccine technology from the Regents of the University of California, or UCSD, and the Dana-Farber/Harvard Cancer Center. Prostate Cancer In 2010, the company licensed patents and related intellectual property relating to three cancer drug candidates developed at the University of Wisconsin. APC-100 is the most advanced of the three drug candidates. APC-200 is a drug candidate for both castrate-sensitive and castrate resistant prostate cancer. APC-300 is a multi-targeted small molecule therapeutic drug. The company primarily focuses on its specialty pharmaceutical products. Other Technologies STI Technology In addition, the company has licensed patented vaccine technology. 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. Research and Development For its nine-month transition period ended December 31, 2014, the company estimate that it spent approximately $3.5 million on research and development activities. Intellectual Property As of March 1, 2015, the company had 8 issued patents in the United States and 4 pending applications, 2 of which have been allowed; 5 issued and 22 pending foreign patent applications relating to APC 5000 DPI and C31G. The company is the licensees of other patents under its various licensing agreements relating to APC 100, APC 200, APC- 300, telomerase, and STI. Regulations 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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