SAN DIEGO, CA--(Marketwired - May 29, 2014) - Adamis Pharmaceuticals
Corporation ADMP today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration for its
epinephrine pre-filled single dose syringe (PFS) product. Specifically the
EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe)
is designed for the emergency treatment of allergic reactions (Type I)
including anaphylaxis. Adamis submitted the NDA pursuant to Section
505(b)(2) of the Food Drug & Cosmetic Act.
Adamis' PFS provides a single dose of epinephrine (adrenaline), which is
considered the drug of choice for immediate administration in acute
anaphylactic reactions to insect stings or bites, allergic reaction to foods
(such as nuts), drugs and other allergens, as well as idiopathic or
exercised-induced anaphylaxis. Adamis' PFS is designed to be the low-cost,
easy-to-use therapeutic alternative to existing epinephrine auto-injectors.
Dr. Dennis Carlo, President and CEO of Adamis, stated, "We feel this NDA
submission represents a major milestone for Adamis. The epinephrine market
is large and growing and we estimate auto-injector sales in the U.S. this
year to approach one billion dollars. I believe our PFS could be an
affordable substitute for the costly auto-injectors. These types of markets
have proven to be cost sensitive and we expect epinephrine to be no
different. Our PFS could allow Adamis to generate significant revenues and
in time lead to profitability."
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 and allergic reactions have become more
widely understood. The company estimates that sales of prescription
epinephrine products in 2013 were at least $900 million, based on industry
data.
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: 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
technology; uncertainties concerning the FDA approval process, including
uncertainties concerning whether the FDA will approve the company's NDA
relating to its PFS product and the timing of the FDA's regulatory process;
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.
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