Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
SAN DIEGO, Jan. 14, 2016 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or “Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. Filed on December 4, 2015, the resubmission was intended to address the issues raised by the FDA in the agency’s March 2015 Complete Response Letter (“CRL”). The FDA indicated that it considered the resubmission to be a complete, class 2 response to the CRL, and provided an agency new action date of June 4, 2016.
About the CRL
In March of 2015, the FDA issued a CRL regarding the Adamis NDA. The substance of the CRL related to the Chemistry, Manufacturing and Controls ("CMC") section, or more specifically, the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the NDA remained open until the issues could be resolved. Adamis took approximately five months to re-engineer the design of the product, manufacture prototypes, and test the new design. In August 2015, Adamis had a telephonic meeting with the FDA to present details of the new design and discuss the preliminary data. Following that meeting, Adamis continued preparations for manufacture of a commercial-ready product as well as testing and validation. Once completed, Adamis revised the NDA to include details of the new design and delivered volume data, and then in December resubmitted the application.
About the Product
Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (PFS) was designed as a lower cost alternative to market leading auto-injectors. Adamis’ PFS provides a single-dose 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 reporting on findings from a 2009-2010 study, 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 immediately 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, Adamis estimates that sales of prescription epinephrine products in 2014 were approximately $1.2 billion.
About Adamis Pharmaceuticals
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-2000 for the treatment of bronchospasms.
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 our future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s NDA relating to its Epinephrine PFS product candidate and the company’s ability to satisfactorily respond to the matters raised in the FDA’s Complete Response Letter relating to the Epinephrine PFS product; the company's beliefs concerning the ability of its product candidates to compete successfully in the market; the company's beliefs concerning the safety and effectiveness of its product candidates; the results of any future clinical trials that the company may conduct relating to its product candidates; the ability to fund future product development; future revenues expected from any of its product candidates, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; and the intellectual property protection that may be afforded by any patents or patent applications relating to its products and product candidates. Statements in this press release concerning future events depend on several factors beyond the company's control, including receipt of adequate funding to support these activities, the absence of unexpected developments or delays, market conditions, and the regulatory approval process. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. There can be no assurances that the company will successfully complete development of the PFS product candidate, that the FDA will approve the NDA following resubmission of the NDA by the company, or that the product will be commercially successful if introduced. The company will require additional funding to commercially launch the product. 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 to the extent required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.
Director, Investor Relations
& Corporate Communications
External Investor Relations
Adamis Pharmaceuticals Corporation