Adamis Pharmaceuticals Updates Symjepi Commercialization Plans
February 23 2018 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided an
update on the progress of exploring commercialization options
relating to the commercial launch of its SymjepiTM (epinephrine)
Injection 0.3mg product, for the emergency treatment of allergic
reactions (Type I) including anaphylaxis.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “As
reflected in our previous statements, since receiving FDA approval
last year we have engaged in a confidential process with the goal
to maximize the value of this asset, including seeking a commercial
partner to launch Symjepi in the U.S. I know many investors have
become frustrated with the time that this process has taken. I too
am frustrated that the process is taking longer than we initially
expected. However, this process has been neither simple nor linear.
We remain committed to bringing Symjepi to the market.”
“While the process is still ongoing, we are now in discussions
with two potential partners. I am confident both groups are capable
of producing value for Symjepi in the market. Each group is engaged
in what we believe are later stages of diligence, which may include
discussions with potential drug buyers, wholesalers and
distributors, that we believe will help refine their commercial
plans. Although of course no assurances are possible, my belief is
that we are finally nearing the conclusion of this process, and I
am hopeful that our next communication will be to announce a
definitive agreement and provide information concerning when
Symjepi may be available in the market.”
About 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. In addition to the 0.3mg product, Adamis has
previously announced that the FDA had accepted its prior approval
supplement for a lower-dose version (0.15mg) of Symjepi intended to
potentially treat patients weighing 33-65 pounds. Both Symjepi
products are intended to provide two single-dose syringes of
epinephrine, which is considered the drug of choice for immediate
administration in acute anaphylactic reactions to foods (such as
nuts), insect stings or bites, drugs and other allergens, as well
as idiopathic or exercise-induced anaphylaxis.
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. In
addition to its epinephrine products, Adamis is developing a
naloxone injection product utilizing the same patented SymjectTM
syringe drug delivery platform. Adamis’ respiratory 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 partnering discussions, the company’s ability to commercialize
its products and product candidates; 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. The timing of a commercial launch of Symjepi will
depend on a number of factors, including without limitation whether
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, when we may enter into
any such agreement, or the date of a commercial launch of SYMJEPI™
Epinephrine PFS. Forward-looking statements in this press
release 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. 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 Contacts
Mark FlatherSenior Director, Investor Relations &Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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