Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that the United States District Court for the
District of Delaware (the “Delaware Court”) ordered Jazz
Pharmaceuticals to delist U.S. Patent No. 8731963 (the “REMS
Patent”) from the U.S. Food and Drug Administration’s (“FDA”)
Orange Book. With this decision, Avadel seeks to accelerate the
FDA’s final approval decision for LUMRYZ™, a once-at-bedtime
investigational formulation of sodium oxybate for the treatment of
cataplexy or excessive daytime sleepiness (EDS) in adults with
narcolepsy.
“We are pleased with the court’s decision in favor of delisting
the REMS Patent from the FDA’s Orange Book, potentially
accelerating a final approval. Upon the delisting of the REMS
Patent, we are prepared to work collaboratively with the FDA to
move to a final approval decision for LUMRYZ,” said Greg Divis,
Chief Executive Officer at Avadel Pharmaceuticals. “We are fully
committed to bringing LUMRYZ to all eligible people with narcolepsy
and look forward to providing updates on our progress.”
On July 18, 2022, LUMRYZ received tentative approval from the
FDA, with potential final approval pending disposition of the REMS
Patent. On October 25, 2022, a Markman hearing was held in which
Avadel renewed its request for expedited consideration of its
pending motion to have the REMS Patent delisted from FDA’s Orange
Book. The Delaware Court granted that request on October 28th and
held a hearing on that motion on November 15, 2022. Earlier today,
the Delaware Court issued its written opinion ordering Jazz to
request delisting of the REMS Patent. With the issuance of this
ruling, Avadel intends to seek final FDA approval for LUMRYZ upon
removal of the REMS Patent from the FDA’s Orange Book.
About LUMRYZ
LUMRYZ is an investigational formulation of sodium oxybate
leveraging our proprietary drug delivery technology and designed to
be taken once-at bedtime for the treatment of cataplexy or
excessive daytime sleepiness (EDS) in adults with narcolepsy.
In March 2020, Avadel completed the REST-ON study, a randomized,
double-blind, placebo-controlled, pivotal Phase 3 trial, to assess
the efficacy and safety of LUMRYZ in patients with narcolepsy.
Among the three co-primary endpoints, LUMRYZ 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 does
when compared to placebo.
In January 2018, the U.S. Food and Drug Administration (FDA)
granted LUMRYZ Orphan Drug Designation for the treatment of
narcolepsy based on the plausible hypothesis that LUMRYZ may be
safer than the twice-nightly formulation of sodium oxybate already
approved by the FDA due to the ramifications associated with dosing
regimen of that product.
On July 18, 2022, the FDA tentatively approved the LUMRYZ NDA
for the treatment of cataplexy or EDS in adults with
narcolepsy.
Avadel is currently evaluating the long-term safety and
tolerability of LUMRYZ 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. Our current lead drug candidate,
LUMRYZ™, is an investigational formulation of sodium oxybate
leveraging our proprietary drug delivery technology and designed to
be taken once at bedtime for the treatment of cataplexy or
excessive daytime sleepiness in adults with narcolepsy. For more
information, please visit www.avadel.com.
Cautionary Disclosure
Regarding Forward-Looking Statements
This 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 our 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 potential therapeutic
benefit of LUMRYZ; the timing of FDA’s final approval decision for
LUMRYZ; ongoing efforts of the Company to accelerate potential
final FDA approval of LUMRYZ; the Company’s efforts to make LUMRYZ
commercially available following potential final approval by the
FDA; and the anticipated market acceptance of LUMRYZ (if approved).
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).
The Company’s 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, the Company’s business
and operations are subject to significant risks, and, as a result,
there can be no assurance that actual results and the results of
the company’s 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 the Company’s forward-looking statements include the risks and
uncertainties described in the “Risk Factors” section of
Part I, Item 1A of the Company’s Annual Report on
Form 10-K for the year ended December 31, 2021, which was
filed with the Securities and Exchange Commission (SEC) 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. The Company does not undertake any
obligation to publicly update or revise our forward-looking
statements, except as required by law.
Investor Contact:Courtney TurianoStern Investor
Relations, Inc.Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Gabriella GreigReal
Chemistryggreig@realchemistry.com (203) 249-2688
Avadel Pharmaceuticals (NASDAQ:AVDL)
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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