FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe

FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe 
SAN DIEGO, CA -- (Marketwired) -- 07/29/14 --   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. 
About 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.  
Adamis Contacts 
Mark Flather
Director, Investor Relations &
Corporate Communications
Adamis Pharmaceuticals Corporation
(858) 412-7951
mflather@adamispharma.com 
Mark Gundy
Outside Investor Relations
872-240-1873
markgundy@gmail.com 
 
 
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