Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
it is reacquiring from Sandoz Inc. the rights to its SYMJEPI ®
(epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection
0.15mg products currently marketed and available in the United
States. Adamis has simultaneously entered into an exclusive
distribution and commercialization agreement with US WorldMeds, LLC
for the United States commercial rights for the SYMJEPI products,
as well as its ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL
product candidate.
Adamis and Sandoz have entered into an agreement providing for
the mutually agreed return to Adamis of the marketing, promotion,
and distribution rights of the SYMJEPI products, and the
termination of the commercialization agreement between Adamis and
Sandoz, following a transition period, supported by a transition
services agreement that is currently being negotiated. As
part of the termination agreement, Sandoz will continue to support
the products in the U.S. under the existing commercialization
agreement through the end of the transition period to help minimize
any potential impact to patients and customers.
Under the terms of the Adamis/US WorldMeds agreement, US
WorldMeds obtained U.S. rights to commercialize and
distribute the SYMJEPI products, upon the termination of Sandoz’
commercial rights, and ZIMHI, if approved by the U.S. Food and Drug
Administration, in exchange for an upfront payment and potential
regulatory and commercial milestones totaling up to $26
million. Additionally, after deducting the supply price and
certain other deductions, including an allocation for US WorldMeds
sales and distribution expenses from net sales of the products,
Adamis and US WorldMeds will share equally in the net
profits, as defined in the agreement.
Adamis will be responsible for supplying the products to US
WorldMeds at a supply price based on Adamis’ direct product
costs. Adamis will retain rights to commercialize the
products outside the U.S. and may also continue to develop its
injection platform for additional product candidates.
Additional information concerning the agreement and the transaction
is contained in a report on Form 8-K to be filed by the company
with the Securities and Exchange Commission.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We
are pleased Sandoz is willing to assist us through this transition
and we are very excited about working with US WorldMeds. They have
a proven track-record of commercializing pharmaceutical products
and have a First-in-Class and only FDA-approved product, LUCEMYRA®
(lofexidine), for the treatment of withdrawal symptoms associated
with abrupt opioid discontinuation. We believe US WorldMeds’
existing infrastructure and current sales force positions it well
to take over the marketing and distribution of our SYMJEPI products
and, after receiving FDA approval, quickly and effectively
launching our ZIMHI product. We view this partnership as a
synergistic fit that has the potential to maximize the value of the
Products and create immediate lasting value to both shareholders
and patients.”
P. Breckinridge Jones, Sr., CEO of US WorldMeds, added, “We are
very excited to begin commercializing Adamis’ SYMJEPI epinephrine
products, and look forward to launching ZIMHI (naloxone) following
its approval. We believe SYMJEPI represents a meaningful new
alternative in the epinephrine market that will benefit from our
enhanced focus. Our strong presence in the opioid dependence
market made us keenly aware of the growing need for repeat dosing
of the currently approved naloxone products to combat the more
powerful opioids in the market today. So, when we learned
Adamis was developing a higher dose naloxone product, we knew it
would be a perfect companion product for LUCEMYRA. We are
confident we can leverage our existing commercial infrastructure to
speed the uptake and maximize the impact of ZIMHI. I consider
ZIMHI and LUCEMYRA a one-two punch that can strike a powerful blow
in the fight against opioid overdoses and the management of
withdrawal symptoms, and ultimately make a positive impact on the
overall opioid epidemic. US WorldMeds expects to be in
position to launch ZIMHI shortly after approval and delivery of
product from Adamis.”
As a consequence of the above agreements, Adamis has filed or
will file a Form 12b-25 with the Securities and Exchange Commission
to give the company additional time to prepare and file its
quarterly report on Form 10-Q for the period ended March 31, 2020,
to assess and reflect this subsequent event and its impact in the
Form 10-Q. The company expects to file its Form 10-Q within
the five additional days provided for by Rule 12b-25.
About the SYMJEPI ProductsSYMJEPI®
(epinephrine) Injection 0.3mg and SYMJEPI® (epinephrine) Injection
0.15mg products are approved by the FDA for use in the emergency
treatment of acute allergic reactions, including anaphylaxis.
In July 2018, Adamis announced that it had licensed commercial
rights for the US to Sandoz. Please refer to www.SYMJEPI.com
for additional product information.
About the ZIMHI ProductZIMHI is a high-dose
naloxone injection product candidate that is intended for the
emergency treatment of opioid overdose, as manifested by
respiratory and/or central nervous system depression in adults and
pediatric patients. It is intended for immediate
administration in settings where opioids may be present and is not
a substitute for emergency medical care. Naloxone is an
opioid antagonist, which is generally considered the drug of choice
for immediate administration for opioid overdose, and works by
blocking or reversing the effects of the opioid, including extreme
drowsiness, slowed breathing, or loss of consciousness. Drug
overdoses are now the leading cause of death for Americans under
50, and more powerful synthetic opioids, like fentanyl and its
analogues, are responsible for the largest number of deaths from
opioid overdoses.
About US WorldMeds and LUCEMYRA®US WorldMeds is
a privately held specialty pharmaceutical company that develops,
licenses, and markets unique healthcare products designed to
improve the lives of patients with challenging conditions and unmet
medical needs. US WorldMeds has built a branded product
portfolio in the therapeutic areas of addiction medicine,
hemophilia, malignant hyperthermia, and CNS. More information
on US WorldMeds can be found at USWorldMeds.com.
LUCEMYRA® (lofexidine) is the first and only
FDA-approved, non-opioid, non-addictive treatment for relief of
multiple symptoms of opioid withdrawal associated with abrupt
opioid discontinuation. More information on LUCEMYRA,
including prescribing and safety information, can be found at
Lucemyra.com.
About Adamis PharmaceuticalsAdamis
Pharmaceuticals Corporation is a specialty biopharmaceutical
company primarily focused on developing and commercializing
products in various therapeutic areas, including respiratory
disease, allergy and opioid overdose. The company’s SYMJEPI
(epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection
0.15mg products both use the same injection device as used for
ZIMHI and were approved by the FDA for use in the
emergency treatment of acute allergic reactions, including
anaphylaxis, and both SYMJEPI products were fully launched in the
U.S. in July 2019. Please refer
to www.SYMJEPI.com for additional product information. In
addition to its ZIMHI (naloxone) injection product candidate,
Adamis is developing other products, including 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 patients, animals, hospitals, clinics
and surgery centers throughout most of the United States.
Adamis Forward Looking StatementsThis 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 plans,
anticipation, intent, contingencies, goals, targets or future
development and/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 ability of the parties to negotiate and enter into
a transition services agreement and the termination of the
company’s existing commercialization agreement with Sandoz; the
timing and outcome of commercialization efforts by US WorldMeds
regarding the SYMJEPI and ZIMHI products; the timing of the
company’s resubmission to the FDA of its New Drug Application
(“NDA”) relating to its ZIMHI product candidate; the timing or
outcome of the FDA’s review of the company’s resubmitted NDA
relating to its ZIMHI product candidate; the company’s beliefs
concerning the size of the markets in which the products compete;
the company’s beliefs concerning the safety and effectiveness of
its products and product candidates; and other statements
concerning our future operations and activities. Such
forward-looking statements include those that express plans,
anticipation, intent, contingencies, goals, targets or future
development and/or otherwise are not statements of historical
fact. These statements 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. There is no
assurance that our commercialization agreement with Sandoz will be
terminated. There is no assurance that the FDA will
approve our NDA, once resubmitted, relating to our ZIMHI naloxone
product candidate or that other matters or events will not differ
from our expectations or result in delays in the regulatory
approval process. In addition, forward-looking
statements concerning our anticipated future activities assume that
we are able to obtain sufficient funding to support such activities
and continue our operations and planned activities. As
discussed in our filings with the Securities and Exchange
Commission, we may require additional funding, and there are no
assurances that such funding will be available if required.
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 release publicly the results of any
revisions to these 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
our filings from time to time with the SEC, including our
annual report on Form 10-K for the year ended December 31,
2019, and our subsequent filings 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.
Contact Adamis:Mark Flather Senior Director,
Investor Relations& Corporate Communications (858)
412-7951mflather@adamispharma.com
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