Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
announced the steps it is taking to explore every available pathway
to accelerate the decision by the U.S. Food and Drug Administration
(FDA) to grant final approval of its lead drug candidate, FT218,
prior to June 2023. Concurrent with this strategy, Avadel has
received and agreed upon what is expected to be a final label and
is completing the last edits of the Risk Evaluation and Mitigation
Strategy (“REMS”) with FDA and expects to receive tentative
approval of FT218.
“We believe the receipt of a tentative approval for the FT218
New Drug Application (NDA) will validate the clinical efficacy and
safety profile of FT218 for people living with narcolepsy and will
provide clarity on the timing and pathway to a potential final
approval and subsequent commercial launch. Nearly every day we hear
from disappointed patients who are waiting for a once at bedtime
oxybate treatment option. We believe FT218 has a clear and
meaningful place in the multi-billion-dollar narcolepsy market and
will continue to pursue every potential option to make it available
as soon as possible to all eligible patients whose lives it has the
potential to improve,” said Greg Divis, Chief Executive Officer of
Avadel Pharmaceuticals. “As part of these efforts, we are
optimizing our cost structure by focusing our existing resources on
our most important priorities, thus extending our cash runway and
subsequent financial bridge to a potential final approval in June
2023 or sooner.”
Avadel, in alignment with our most important priorities, is
taking the following actions, including those that can potentially
accelerate FDA’s final approval decision and shorten the timeline
between approval and launch of FT218:
- Submitted a Paragraph IV patent certification and expects to
receive a tentative approval.
- Filed a motion in the U.S. District Court of Delaware to delist
US Patent No. 8,731,963 (the “REMS patent”), from FDA’s Orange
Book. A court order requiring the patent holder to delist the REMS
patent from the Orange Book could provide a pathway for a final
approval of FT218 prior to June 2023.
- Preparing for a claim construction hearing (“Markman hearing”)
in the existing patent litigation in the U.S. District Court of
Delaware which is scheduled for August 31, 2022. The Court has
previously stated this claim construction hearing needs to take
place prior to ruling on the motion to delist the REMS patent from
the Orange Book.
- Investing in patient and physician education including the
Company’s disease state program, www.narcolepsydisrupts.com, which
has resulted in over 5,000 narcolepsy patient enrollments in the
first half of 2022.
- Continuing key activities in anticipation of a final approval
on or before June 2023, including planning for the final
preparation of the FT218 REMS program and the continued
manufacturing of commercial supply.
- Optimizing the cost structure to reduce total quarterly cash
operating expenses to $12.0 to $14.0 million, excluding inventory
purchases. A restructuring charge of between $3.0 - $4.0 million,
comprised primarily of severance related costs associated with a
nearly 50% reduction in workforce, is expected to be recorded in
the second quarter of 2022. The Company expects to report greater
than $100.0 million of cash, cash equivalents and marketable
securities as of June 30, 2022.
Based on extensive market research and comprehensive claims data
analytics, Avadel estimates the total patient population could be
in the range of approximately 30,000-35,000 and expects FT218, if
approved, to be the treatment of choice for patients suffering from
narcolepsy-related excessive daytime sleepiness (EDS) or cataplexy.
The current twice-nightly U.S. narcolepsy oxybate market is
estimated at $1.8 billion comprised of approximately 16,000
patients. In addition, Avadel estimates that in the last three
years, 10,000 – 15,000 patients have discontinued their
twice-nightly oxybate use, many due to the complications associated
with the middle of the night dosing. Furthermore, based on an
analysis of U.S. claims data, the Company believes that each year
approximately 3,000 patients initiate oxybate treatment for the
first time and expects this to grow by 25-50% over time with the
introduction of FT218. Based on the estimated total patient
population, the potential market opportunity could be in excess of
$3.0 billion annually.
Conference CallTo access the conference call,
investors are invited to dial (844) 388-0559 (U.S. and Canada) or
(216) 562-0393 (International). The conference ID number is
4176205. A live audio webcast can be accessed by visiting the
investor relations section of the Company’s website,
www.avadel.com. A replay of the webcast will be archived on
Avadel’s website for 90 days following the event.
About FT218FT218 is an investigational
formulation of sodium oxybate leveraging the Company’s proprietary
drug delivery technology and designed to be taken once at bedtime
for the treatment of EDS or cataplexy in adults with
narcolepsy.
In March 2020, Avadel completed the REST-ON trial, a randomized,
double-blind, placebo-controlled, pivotal Phase 3 trial, to assess
the efficacy and safety of FT218 in adults with narcolepsy. Among
the three co-primary endpoints, FT218 demonstrated statistically
significant and clinically meaningful results in EDS, the
clinician’s overall assessment of the patient’s functioning, and
reduction in cataplexy attacks for all three evaluated doses
compared to placebo.
In January 2018, the FDA granted FT218 Orphan Drug Designation
for the treatment of narcolepsy based on the plausible hypothesis
that FT218 may be clinically superior to the twice-nightly
formulation of sodium oxybate already approved by the FDA for those
with narcolepsy due to the consequences of middle-of-the-night
dosing of the approved product. The NDA for FT218 is currently
under review by the FDA.
Avadel is currently evaluating the long-term safety and
tolerability of FT218 in the open-label RESTORE clinical study. For
more information, visit: www.restore-narcolepsy-study.com.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company
focused on transforming medicines to transform lives. Our approach
includes applying innovative solutions to the development of
medications that address the challenges patients face with current
treatment options. Avadel’s current lead drug candidate, FT218, is
an investigational formulation of sodium oxybate leveraging its
proprietary drug delivery technology and designed to be taken once
at bedtime for the treatment of excessive daytime sleepiness and
cataplexy in adults with narcolepsy. For more information, please
visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking
StatementsThis press release includes “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
These forward-looking statements relate to the Company’s future
expectations, beliefs, plans, strategies, objectives, results,
conditions, financial performance, prospects, or other events. Such
forward-looking statements include, but are not limited to:
expectations regarding the FDA’s tentative and/or full approval of
the FT218 NDA; the commercial launch of FT218, if approved; the
potential therapeutic benefit of FT218; the timing and results of
the Company’s cost structure optimization efforts; the estimated
charges and costs expected to be incurred in connection with such
cost structure optimization efforts; the projected cost savings
resulting from the Company’s cost structure optimization efforts;
and, if approved, the potential market opportunity for FT218. In
some cases, forward-looking statements can be identified by the use
of words such as “will,” “may,” “could,” “believe,” “expect,” “look
forward,” “on track,” “guidance,” “anticipate,” “estimate,”
“project,” “next steps” and similar expressions, and the negatives
thereof (if applicable).
Our forward-looking statements are based on estimates and
assumptions that are made within the bounds of our knowledge of our
business and operations and that we consider reasonable. However,
our business and operations are subject to significant risks, and,
as a result, there can be no assurance that actual results and the
results of our business and operations will not differ materially
from the results contemplated in such forward-looking statements.
Factors that could cause actual results to differ from expectations
in our forward-looking statements include the risks and
uncertainties described in the “Risk Factors” section of Part I,
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2021, which we filed with the Securities and Exchange
Commission on March 16, 2022, and subsequent SEC filings.
Forward-looking statements speak only as of the date they are
made and are not guarantees of future performance. Accordingly, you
should not place undue reliance on forward-looking statements. We
do not undertake any obligation to publicly update or revise our
forward-looking statements, except as required by law.
Investor Contact:Courtney TurianoStern IR, Inc.
courtney.turiano@sternir.com(212) 698-8687
Media Contact:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com(408) 568-4292
Brandi RobinsonAvadel Pharmaceuticalsbrobinson@avadel.com(636)
383-4302
Avadel Pharmaceuticals (NASDAQ:AVDL)
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