Adamis Pharmaceuticals Submits Prior Approval Supplement to FDA for the Pediatric Version of Symjepi
November 29 2017 - 4:05PM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced
the submission of a prior approval supplement to the U.S. Food and
Drug Administration (“FDA”) for a pediatric version (0.15mg) of
Symjepi™.
Symjepi (epinephrine) Injection 0.3mg is an FDA-approved
product, for the emergency treatment of allergic reactions (Type I)
including anaphylaxis, designed for patients weighing 66 pounds or
greater. The pediatric version (0.15mg) is intended to potentially
treat patients weighing 33-65 pounds. Both Symjepi products
are intended to provide two single-dose syringes of epinephrine
(adrenaline), which is considered the drug of choice for immediate
administration in acute anaphylactic reactions to allergic reaction
to foods (such as nuts), insect stings or bites, drugs and other
allergens, as well as idiopathic or exercise-induced
anaphylaxis.
Dr. Dennis Carlo, President and CEO of Adamis, stated, “With
this submission we are excited to take another step forward to
provide this potentially life-saving treatment to a broader range
of patients that are at risk of anaphylaxis."
Dr. Carlo continued, “I know there is great interest in the
commercial plan for Symjepi. We are in confidential
discussions with several potential partners. We remain
committed to bring Symjepi to market and intend to announce our
commercial plan once definitive arrangements have been
finalized.”
About Anaphylaxis
The American Academy of Allergy Asthma and Immunology, or AAAAI,
defines anaphylaxis as a serious life-threatening allergic
reaction. The most common anaphylactic reactions are to foods,
insect stings, medications and latex. According to information
published by AAAAI reporting on findings from a 2009-2010 study, up
to 8% of U.S. children under the age of 18 had a food allergy, and
approximately 38% of those with a food allergy had a history of
severe reactions. Anaphylaxis requires immediate medical treatment,
including an injection of epinephrine.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company focused on developing and commercializing
products in the therapeutic areas of respiratory disease and
allergy. The company’s first product, Symjepi (epinephrine)
Injection 0.3mg, was approved in June 2017 for use in the emergency
treatment of acute allergic reactions, including anaphylaxis.
Adamis’ product pipeline includes HFA metered dose inhaler and dry
powder inhaler products for the treatment of bronchospasm and
asthma.
The Company’s U.S. Compounding, Inc. (USC) subsidiary, which is
registered as a drug compounding outsourcing facility under Section
503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug
Quality and Security Act, compounds sterile prescription drugs, and
certain nonsterile drugs, to patients, physician clinics,
hospitals, surgery centers and other clients throughout most of the
United States.
Adamis 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 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 prior approval supplement to
its New Drug Application (NDA), relating to the Symjepi™
(epinephrine) Injection 0.15mg pediatric dose pre-filled syringe
product candidate; the company’s ability to commercialize its
products and product candidates; the timing and nature of the
company’s commercialization plans for Symjepi; the company's
beliefs concerning the ability of its products and product
candidates to compete successfully in the market; and the company's
beliefs concerning the safety and effectiveness of its products and
product candidates. 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 those contemplated by these forward-looking statements.
There can be no assurances that the FDA will approve the prior
approval supplement to the NDA relating to the pediatric dose
product candidate, concerning the timing of any such approval, or
that the product will be commercially successful if approved and
introduced. The FDA review process is subject to a number of
uncertainties. The FDA could request additional or different
submissions or request additional data, information, materials or
clarification, all of which could affect the timing and outcome of
the review process. As a result, there can be no assurances
regarding the timing or the outcome of the FDA’s review process
relating to the Symjepi™ (epinephrine) Injection 0.15mg pediatric
dose pre-filled syringe product candidate. In addition, the
timing of a commercial launch of Symjepi will depend on a number of
factors, including without limitation whether or not we enter into
an agreement with a commercialization partner and, if we enter into
such an agreement, the terms of any such agreement and the plans of
the commercialization partner. As a result, there are no
assurances regarding whether we will enter into an agreement with a
commercialization partner regarding Symjepi, when we may enter into
any such agreement, or the date of a commercial launch of Symjepi.
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. Any forward-looking statement in
this press release speaks only as of the date on which it is
made. Except to the extent required by law, Adamis expressly
disclaims any obligation to update any forward-looking
statements.
Adamis Contact
Mark FlatherSenior Director, Investor Relations &Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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