Adamis Pharmaceuticals Provides Update on Its Higher Dose Naloxone Injection Product
June 11 2019 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that the U.S. Food and Drug Administration (FDA) has
acknowledged the receipt of Adamis’ amendment to its previously
submitted New Drug Application (NDA) for its higher dose naloxone
injection product. This revision removed EVZIO® as a
Reference Listed Drug (RLD) and withdrew the associated Paragraph
IV certification. Narcan injectable (NDA 016636) now remains
as the sole RLD and, because there are no Orange Book listed
patents for NDA 016636, no patent certification is required.
With this change, it is Adamis’ opinion that the amended NDA will
not be subject to a 30-month stay and that the FDA will be free to
issue an approval as soon as the agency completes a satisfactory
review of the Adamis naloxone NDA.
Adamis decided to amend its original NDA after consulting with
the FDA regarding the proposed change. The removal of the
Paragraph IV certification does not terminate the previously
announced lawsuit filed by kaléo Inc. in the United States District
Court for the District of Delaware, which alleges, among other
things, that Adamis’ product infringes patents purportedly held by
kaléo. As previously stated, Adamis believes that its higher
dose naloxone injection product does not infringe any valid and
enforceable patent held by kaléo and that kaléo’s patent
infringement allegation is without merit. Adamis has
separately demanded that Cooley LLP withdraw as counsel for
kaléo. Cooley has served as counsel to Adamis since Adamis’
formation in 2006, has counseled Adamis on all areas of its
business and has a clear conflict of interest. Adamis will
continue to vigorously defend its naloxone injection product
against any and all patent infringement allegations.
“Adamis is fully committed to working with the FDA to facilitate
their review of our NDA,” said Dr. Dennis J. Carlo, President and
CEO of Adamis. “We hope that, if approved, our higher dose naloxone
injection product can become part of the solution to the
devastating epidemic of opioid overdose.”
Background on the Product Candidate
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. 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.
Hatch-Waxman and Paragraph IV Certification
Companies pursuing abbreviated drug applications, either via
ANDA or Section 505(b)(2) of the U.S. Food, Drug & Cosmetic
Act, as amended, are not required to conduct new clinical trials to
demonstrate safety and efficacy. Instead these companies may
rely on the research of a previously approved, reference listed
drug (RLD). Under the Drug Price Competition and Patent Term
Restoration Act, commonly referred to as Hatch-Waxman, companies
relying on a RLD that has listed patents, must certify to the FDA
that the product candidate does not infringe on any patents listed
for the RLD (a Paragraph IV certification). If the owner of
an RLD files a lawsuit disputing a Paragraph IV certification, the
FDA will wait until the shorter of 30 months or the dispute is
resolved by a court, before approving the NDA.
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; any action that kaléo
Inc. may take in response to the company’s amended NDA filing,
including the removal of EVZIO® as a Reference Listed Drug and
withdrawal of the associated paragraph IV certification; 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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