Adamis’ Commercial Partner Launches SYMJEPI™ (epinephrine) in the US
16 Enero 2019 - 3:18PM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
that its marketing and commercial partner, Sandoz Inc. (Sandoz), a
Novartis division, has launched SYMJEPI™ (epinephrine) 0.3 mg
Injection in the US market for the emergency treatment of allergic
reactions (Type 1), including anaphylaxis. Sandoz is launching this
medicine as an affordable, single-dose, pre-filled syringe
alternative to epinephrine auto-injectors. Sandoz release
SYMJEPI will be rolled out via a phased launch and will
initially be available in the institutional setting, an established
channel where Sandoz Inc. has significant experience and knowledge,
followed by introduction into the retail market.
SYMJEPI 0.3 mg Injection is indicated for the emergency
treatment of allergic reactions (Type 1), including anaphylaxis, to
stinging and biting insects, allergen immunotherapy, foods, drugs,
diagnostic testing substances and other allergens, as well as
idiopathic or exercise-induced anaphylaxis. SYMJEPI 0.3 mg
Injection is intended for immediate administration in patients who
weigh 66 pounds or more and are determined to be at an increased
risk for anaphylaxis.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “This launch is a significant
milestone in the history of our company. Both Symjepi 0.3 mg and
Symjepi 0.15 mg products stem from Adamis’ commitment to develop
and provide high quality, affordable treatment options to patients.
With recent news of epinephrine product shortages in the US, we
worked together with Sandoz in getting this potentially life-saving
quality product into the market as quickly as possible. We are very
excited to be partnered with Sandoz and anticipate a successful
launch of this product.”
We are also working closely with Sandoz to prepare for the US
launch of Symjepi 0.15 mg Injection, approved by the US Food and
Drug Administration in September 2018, to treat patients who weigh
between 33 and 65 pounds.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
respiratory disease and allergy. The company’s Symjepi
(epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection
0.15 mg products were approved for use in the emergency treatment
of acute allergic reactions, including anaphylaxis. Adamis
previously announced a distribution and commercialization agreement
with Sandoz, a division of Novartis Group, to market Symjepi in the
U.S. Adamis is developing additional products, including a
sublingual tadalafil product candidate for the treatment of
erectile dysfunction, a naloxone injection product candidate for
the treatment of opioid overdose, and a metered dose inhaler and
dry powder inhaler product candidates for the treatment of asthma
and COPD. The company’s subsidiary, U.S. Compounding, Inc.,
compounds sterile prescription drugs, and certain nonsterile drugs
for human and veterinary use, 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. Such forward-looking statements include those that
express or relate to plans, anticipation, intent, contingencies,
goals, targets or future development, or otherwise are not
statements of historical fact. 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 nature and success of launch and commercialization
arrangements and activities for its Symjepi (epinephrine) Injection
0.3mg and Symjepi (epinephrine) Injection 0.15mg products; beliefs
concerning the significance of the Symjepi launch to the company;
the company’s beliefs concerning the ability of its products and
product candidates to compete successfully in the market; the
company’s beliefs concerning the safety and effectiveness of its
products and product candidates; anticipated dates for commercial
introduction of products into various markets; guidance regarding
future periods; and other statements concerning our future
operations and activities. Statements in this press release
concerning future events depend on several factors beyond the
company's control, including without limitation market conditions,
the commercial success of launch of Symjepi into the institutional
channel or any subsequent introductions in other markets, the
absence of unexpected developments or delays, and unexpected safety
or effectiveness developments. There are no assurances that
launch of the Symjepi product into the institutional channel or any
subsequent introductions in other markets will be successful.
Any forward-looking statements in this press release are only
predictions, are not guarantees, involve known and unknown risks,
uncertainties and other factors, and concern matters that could
subsequently differ materially from those described in this press
release, which may cause Adamis' actual results to be materially
different from those contemplated by these forward-looking
statements. In addition, we cannot assess the impact of each
factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements. You should not place undue reliance on any
forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and
except as may be required by applicable law, we undertake no
obligation to update or revise any forward-looking statements or to
reflect events or circumstances arising after the date of this
press release. Certain of these risks, and additional risks,
uncertainties, and other factors are described in greater detail in
Adamis’ filings from time to time with the SEC, including its
annual report on Form 10-K for the year ended December 31, 2017,
and quarterly reports filed 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.
Contacts: Mark Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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