Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent
10 January 2023 - 08:15AM
Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq:
ASRT), a specialty pharmaceutical company offering differentiated
products to patients, today announced that U.S. Patent, No.
11541002 for Sympazan® oral film is now listed in the U.S. Food and
Drug Administration (“FDA”) publication, Approved Drug Products
with Therapeutic Equivalence Evaluations, commonly known as the
Orange Book.
The patent, which is valid until 2039, is assigned to Aquestive
Therapeutics, Inc. and exclusively licensed to Assertio. It covers
an oral film for delivering clobazam and methods for using the film
to treat epilepsy and/or seizures. Aquestive will continue to
prosecute additional US patent application(s) to further strengthen
the portfolio on this product.
“We are pleased to see this patent listed in the Orange Book, as
originally anticipated in our Sympazan licensing agreement with
Aquestive. This patent is complementary to two other Sympazan
patents already listed in the Orange Book and extends patent
coverage until 2039 for this innovative and attractive oral film
delivery system for clobazam,” Dan Peisert, President and Chief
Executive Officer of Assertio.
“Sympazan exemplifies the type of longer duration assets we are
seeking to add to the portfolio as we continue to diversify and
expand our platform,” said Vanessa Fox, Vice President, Business
Development and Commercial Analytics. “We continue to work a robust
pipeline of business development projects in support of our goal to
add $50 million of incremental gross profit by 2024, of which we
have now secured $18 million from the combination of our Otrexup
and Sympazan transactions, both of which include notable growth
opportunities.”
About Sympazan
Trade Name |
Sympazan® (clobazam) oral film formulation |
Indication |
For the adjunctive treatment of seizures associated with
Lennox‐Gastaut Syndrome (LGS) in patients aged 2 years of age or
older |
Last to Expire Orange Book Listed Patent |
September 2039 |
Trailing 12 Months Revenue Ended 6/30/22 |
Approximately $9.5 Million |
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL
REACTIONS • Concomitant use of benzodiazepines and opioids
may result in profound sedation, respiratory depression, coma, and
death. Reserve concomitant prescribing of these drugs in patients
for whom alternative treatment options are inadequate. Limit
dosages and durations to the minimum required. Follow patients for
signs and symptoms of respiratory depression and sedation. • The
use of benzodiazepines, including SYMPAZAN, exposes users to risks
of abuse, misuse, and addiction, which can lead to overdose or
death. Before prescribing SYMPAZAN and throughout treatment, assess
each patient’s risk for abuse, misuse, and addiction.• Abrupt
discontinuation or rapid dosage reduction of SYMPAZAN after
continued use may precipitate acute withdrawal reactions, which can
be life-threatening. To reduce the risk of withdrawal reactions,
use a gradual taper to discontinue SYMPAZAN.
Important Safety Information
SYMPAZAN is a benzodiazepine medicine. Taking benzodiazepines
with opioid medicines, alcohol, or other central nervous system
(CNS) depressants (including street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma, and
death.Get emergency help right away if any of the following
happens:
- shallow or slowed breathing
- breathing stops (which may lead to the heart stopping)
- excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how
taking SYMPAZAN with opioids affects you.
Please see full Prescribing Information including Boxed Warning
on risks from concomitant use with opioids; abuse, misuse and
addiction; and dependence and withdrawal reactions at
www.sympazan.com/pdfs/pi.pdf
About Assertio
Assertio is a specialty pharmaceutical company offering
differentiated products to patients utilizing a non-personal
promotional model. We have built and continue to build our
commercial portfolio by identifying new opportunities within our
existing products as well as acquisitions or licensing of
additional approved products. To learn more about Assertio, visit
www.assertiotx.com.
Investor Contact
Matt KrepsManaging DirectorDarrow AssociatesAustin, TX M:
214-597-8200mkreps@darrowir.com
Forward Looking Statements
Statements in this communication that are not historical facts
are forward-looking statements that reflect Assertio's current
expectations, assumptions and estimates of future performance and
economic conditions. These forward-looking statements are made in
reliance on the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements relate to, among other things, future events or the
future performance or operations of Assertio, including our ability
to realize the benefits from our operating model, successfully
acquire and integrate new assets including Sympazan and explore new
business development initiatives, as well as Aquestive’s ability to
successfully prosecute the pending patent application and timing of
allowance by the USPTO. All statements other than historical facts
may be forward-looking statements and can be identified by words
such as "anticipate," "believe," "could," "design," "estimate,"
"expect," "forecast," "goal," "guidance," "imply," "intend," "may",
"objective," "opportunity," "outlook," "plan," "position,"
"potential," "predict," "project," "prospective," "pursue," "seek,"
"should," "strategy," "target," "would," "will," "aim" or other
similar expressions that convey the uncertainty of future events or
outcomes and are used to identify forward-looking statements. Such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and other factors, some of
which are beyond the control of Assertio, including the risks
described in Assertio's Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q filed with the U.S. Securities and Exchange
Commission ("SEC") and in other filings Assertio makes with the SEC
from time to time. Investors and potential investors are urged not
to place undue reliance on forward-looking statements in this
communication, which speak only as of this date. While Assertio may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to update or
revise any forward-looking-statements contained in this press
release whether as a result of new information or future events,
except as may be required by applicable law. Nothing contained
herein constitutes or will be deemed to constitute a forecast,
projection or estimate of the future financial performance or
expected results of Assertio.
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