Full Press Release Details
Avadel Pharmaceuticals
Provides Corporate Update
- Pursuing strategies to accelerate final approval of FT218 NDA
- Optimizing cost structure to fund strategic priorities and extend cash runway
- Continuing key activities to accelerate launch timing of FT218, targeting multi-billion-dollar narcolepsy market opportunity
to host a conference call tomorrow, June 30 at 8:00 a.m. ET
DUBLIN, Ireland, June 29, 2022 - 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:
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.
To 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.
FT218 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 plc
Avadel 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 Statements
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).
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
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.
Avadel Pharmaceuticals