Adamis Pharmaceuticals Announces Patent Litigation Regarding Its Higher Dose Naloxone Injection Product
21 Mayo 2019 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that on May 20, 2019, it received notice that it had been
named and served as a defendant in a lawsuit filed by kaléo Inc. in
the United States District Court for the District of Delaware
regarding Adamis’ higher dose naloxone injection product candidate
for the treatment of opioid overdose, for which Adamis has
previously submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) that is being reviewed by the
agency. The complaint alleges, among other things, that the
company’s product candidate infringes patents purportedly held by
kaléo relating to its naloxone auto-injector product. The
action was filed under the provisions of the Hatch-Waxman Act in
response to Adamis’ Paragraph IV certification regarding the kaléo
patents as part of the company’s NDA process, and results in an
automatic stay of any final approval by the FDA of Adamis’
NDA. Adamis does not anticipate this stay would interrupt or
delay the FDA’s ongoing review of the NDA; however, if the patent
dispute is unresolved by the time the FDA was prepared to grant an
approval, the company believes that the agency would grant
conditional approval until the sooner of October 4, 2021 or until
final resolution of the matter before the court, whichever occurs
sooner.
Adamis believes that its naloxone injection product, which
combines a generic formulation of naloxone with Adamis’ proprietary
injection device, does not infringe any valid and enforceable
patent held by kaléo and that kaléo’s complaint is without
merit. Adamis intends to defend against kaléo claims and
pursue all available legal remedies available to the company
against kaléo and, if appropriate, its outside counsel.
Background
In December 2018, Adamis filed an NDA relating to its higher
dose naloxone injection product. In March 2019, Adamis
received a notice from the FDA that the NDA was sufficiently
complete to permit a substantive review with a target action date
of October 31, 2019. As is part of this kind of application,
Adamis’ NDA included Paragraph IV certification with respect to
certain patents listed in the FDA’s Orange Book for kaléo, Inc.’s
EVZIO® product. As contemplated under the applicable federal
laws and procedures, Adamis certified that each was invalid,
unenforceable, or will not be infringed by the Adamis naloxone
injection product and sent a notice letter to kaléo informing kaléo
of the Paragraph IV certification.
About Naloxone Injection
Naloxone is an opioid antagonist used to treat narcotic
overdoses. Naloxone, which is generally considered the drug
of choice for immediate administration for opioid overdose, blocks
or reverses the effects of the opioid, including extreme
drowsiness, slowed breathing, or loss of consciousness. Common
opioids include morphine, heroin, tramadol, oxycodone, hydrocodone
and fentanyl. According to statistics published by the Centers
for Disease Control and Prevention, in 2017, drug overdoses
resulted in approximately 72,000 deaths in the United
States – nearly 200 deaths per day. Drug overdoses are
now the leading cause of death for Americans under 50, and the
proliferation of more powerful synthetic opioids, such as fentanyl
and its analogues, could result in future increases in the number
of deaths resulting from opioid overdoses. Based on the
current opioid epidemic, particularly involving the more potent
fentanyl narcotics, the company and others have published reports
supporting the need for a higher dose naloxone product.
In December 2018, the joint meeting of the Anesthetic and
Analgesic Products Advisory Committee and the Drug Safety and Risk
Management Advisory Committee voted in favor of adding labeling
language that recommends co-prescription of naloxone for all or
some patients prescribed opioids. Medicare (HHS) has also
recommended co-prescribing naloxone with opioids under certain
conditions. These recommendations could significantly
increase the naloxone market.
About Adamis
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 TM
(epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection
0.15mg products are FDA approved for use in the emergency treatment
of acute allergic reactions, including anaphylaxis. 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. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the outcome of the patent infringement lawsuit filed by
kaléo; the company’s ability to successfully enforce and defend its
intellectual property rights; the potential costs associated with
the patent infringement lawsuit; any future actions of the FDA
arising from the patent infringement lawsuit; the impact of the
patent infringement lawsuit on our business, results of operations
and financial position; the company’s beliefs concerning drug
overdoses in the United States, illicit use of opioids in the
United States, and deaths due to fentanyl and other opioids; use of
naloxone to help treat opioid overdoses; the potential for future
growth in the naloxone market; the company’s beliefs concerning the
timing and outcome of the FDA’s review of the company’s NDA
relating to its naloxone product candidate and its review of the
proposed brand name for the product; the company’s ability to
successfully develop its naloxone product candidate and other
product candidates; and the outcome of any discussions with third
parties concerning commercialization of the product. 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 are no assurances
concerning the outcome of the patent lawsuit filed by kaléo.
The lawsuit could require material financial resources and consume
significant management time to resolve, regardless of the outcome
of the proceedings. The lawsuit, or an adverse outcome in the
litigation, could have a material adverse effect on our naloxone
product candidate and the company’s business, financial conditions
and results of operations. In addition, there can be no
assurances that the FDA will approve our NDA relating to
our naloxone product candidate or will give final approval to our
proposed brand name for the product, concerning the timing of any
such approval, that the product will be commercially successful if
approved and introduced, or concerning the outcome of any
discussions with third parties concerning commercialization of the
product. 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 clinical trials or studies, 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. 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.
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 Adamis’ filings from time to
time with the SEC, including its most recent annual report on Form
10-K 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.
Contacts: Mark Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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