Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for FT 218 for the Treatment of Narcolepsy
10 1월 2018 - 9:30PM
Avadel Pharmaceuticals plc (NASDAQ:AVDL), “Avadel” or “the
Company,” today announced that FT 218 has been granted Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of narcolepsy. FT 218, a once-nightly formulation of
sodium oxybate using Avadel’s proprietary Micropump® technology, is
currently undergoing testing in a Phase III clinical trial for the
treatment of excessive daytime sleepiness (EDS) and cataplexy in
patients suffering from narcolepsy. The designation has been
granted on the plausible hypothesis that FT 218 may be clinically
superior to the same drug already approved for the same indication
because FT 218 may be safer due to ramifications associated with
the dosing regimen of the previously-approved product.
Mike Anderson, Avadel’s Chief Executive Officer,
said, “Receipt of Orphan Drug Designation for FT 218 is meaningful
for both Avadel and patients suffering from Narcolepsy. Narcolepsy
is a debilitating and rare sleep disorder for which limited
treatment options exist. We look forward to completing our REST-ON
Phase III trial this year and are hopeful that FT 218 can provide
meaningful benefit to patients and their quality of life over other
standards of care.”
Orphan Drug status is intended to advance drug
development for rare diseases. The FDA provides Orphan Drug
Designation to drugs and biologics that demonstrate promise for the
diagnosis and/or treatment of rare diseases or conditions that
affect fewer than 200,000 people in the U.S. The designation can
provide development and commercial incentives for designated
compounds and medicines, including eligibility for a seven-year
period of market exclusivity in the U.S. after product approval,
FDA assistance in clinical trial design and an exemption from FDA
user fees.
About REST-ON Phase III Clinical
Trial
REST-ON is a double-blind, randomized, placebo
controlled study of 264 patients to assess the efficacy and safety
of a once nightly formulation of sodium oxybate for
extended-release oral suspension for the treatment of excessive
daytime sleepiness and cataplexy in patients suffering from
narcolepsy. For more information, please visit
www.rethinknarcolepsy.com.
About Avadel Pharmaceuticals
plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
specialty pharmaceutical company that seeks to develop
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, by utilizing its
proprietary drug delivery technology and in-licensing / acquiring
new products; ultimately, helping patients adhere to their
prescribed medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri, United States and Lyon, France. For more information,
please visit www.avadel.com.
Safe Harbor: This press release
may include 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. The words “will,” “may,”
“believe,” “expect,” “anticipate,” “estimate,” “project” and
similar expressions, and the negatives thereof, identify
forward-looking statements, each of which speaks only as of the
date the statement is made. Although we believe that our
forward-looking statements are based on reasonable assumptions
within the bounds of our knowledge of our business and operations,
our business is subject to significant risks and as a result there
can be no assurance that actual results of our research,
development and commercialization activities and our results of
operations will not differ materially from the results contemplated
in such forward-looking statements. These risks include: (i) the
risks that we may not achieve our goals for 2018, including to (A)
achieve a full-scale commercial launch of Noctiva, (B) complete
patient enrollment for our REST-ON clinical trial and file an NDA
for FT218, (C) file an NDA for a fourth UMD product (AV001), (D)
maintain a leading position in our three hospital products, (E)
improve the effectiveness and efficiency of our pediatric
operations, (F) enhance our portfolio through M&A activity and
(G) generate revenues of between $110 million and $130 million;
(ii) risks relating to our license agreement with Serenity
Pharmaceuticals, LLC including that our internal analyses may
overstate the market opportunity in the United States for the drug
desmopressin acetate (the “Drug”) or we may not effectively exploit
such market opportunity, that significant safety or drug
interaction problems could arise with respect to the Drug, that we
may not successfully increase awareness of nocturia and the
potential benefits of the Drug, and that the need for management to
focus attention on the development and commercialization of the
Drug could cause our ongoing business operations to suffer; and
(iii) the other risks, uncertainties and contingencies described in
the Company's filings with the U.S. Securities and Exchange
Commission, including our annual report on Form 10-K for the year
ended December 31, 2016, in particular under the captions
“Forward-Looking Statements” and “Risk Factors,” including without
limitation: our dependence on a small number of products and
customers for the majority of our revenues; the possibility that
our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent
protected, could face substantial competition resulting in a loss
of market share or forcing us to reduce the prices we charge for
those products; the possibility that we could fail to successfully
complete the research and development for pipeline products we are
evaluating for potential application to the FDA pursuant to our
"unapproved-to-approved" strategy, or that competitors could
complete the development of such products and apply for FDA
approval of such products before us; the possibility that our
products may not reach the commercial market or gain market
acceptance; our need to invest substantial sums in research and
development in order to remain competitive; our dependence on
certain single providers for development of several of our drug
delivery platforms and products; our dependence on a limited number
of suppliers to manufacture our products and to deliver certain raw
materials used in our products; the possibility that our
competitors may develop and market technologies or products that
are more effective or safer than ours, or obtain regulatory
approval and market such technologies or products before we do; the
challenges in protecting the intellectual property underlying our
drug delivery platforms and other products; and our dependence on
key personnel to execute our business plan. Except as may be
required by law, we disclaim any obligation to publicly update any
forward-looking statements to reflect events after the date of this
press release.
Contacts: |
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Michael F.
Kanan |
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Chief Financial
Officer |
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Phone: (636)
449-1844 |
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Email:
mkanan@avadel.com |
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Lauren
Stival |
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Sr. Director,
Investor Relations & Corporate Communications |
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Phone: (636)
449-5866 |
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Email:
lstival@avadel.com |
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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