SAN DIEGO, CA--(Marketwired - Jul 29, 2014) - Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for the product, EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (PFS), for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Dr. Dennis Carlo, President and CEO of Adamis, stated, "This is a major milestone in that the PFS will be the company's first product to generate revenues. With the FDA's acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for the PFS in the U.S. in the first half of 2015."
Designed as a low cost alternative to market leading auto-injectors, Adamis' PFS provides two single dose syringes of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, foods (such as nuts), drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis.
Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by industry sources, up to 8% of U.S. children under the age of 18 have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis has become more widely understood. Based on industry data, the company estimates that sales of prescription epinephrine products in 2013 were at least $900 million.
About Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease, allergy, oncology and immunology. The company's current specialty pharmaceutical product candidates include the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease, and APC-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. The company's vaccine product candidates and cancer drug product candidates under research and development include TeloB-VAX, a cell-based therapeutic cancer vaccine and three drugs, APC-100, APC-200, and APC-300, for the treatment of prostate cancer.
Forward Looking Statements
This press release may contain forward-looking statements that relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: uncertainties concerning the FDA approval process, including uncertainties concerning whether the FDA will approve the company's NDA relating to the company's PFS product and the timing of the FDA's regulatory process; the ability to fund future product development and business operations; future revenues expected from any of the company's product candidates, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; the intellectual property protection that may be afforded by any patents or patent applications relating to the company's technologies; and the size of the market for prescription epinephrine products or the company's PFS product and the absence of any assurances concerning whether the size of that market or the rate of prescriptions will increase or grow, or decrease, in the future. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Except as required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.