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Avadel Pharmaceuticals Announces FT218 Leadership Transition
Jordan Dubow , M.D. stepping down as CMO and will continue as a consultant to the Company through the FT218 NDA submission and review- Seasoned industry veteran and Avadel Board member,
Mark McCamish , M.D., Ph.D., to work with management and provide direct leadership of the FT218 program
“We thank Jordan for his hard work and dedication as our Chief Medical Officer, including the important role he played in the acceleration of and reporting the data from our pivotal Phase 3 REST-ON study that produced robust and statistically significant results across all primary endpoints. With that phase complete, we believe the addition of Mark’s extensive experience and direct leadership of the FT218 filing serves to strengthen our internal and external teams, which include world class capabilities in the fields of clinical development, regulatory affairs and CMC. As a result, I have the utmost confidence in our team and I am confident this change will not impact the timing of our planned NDA filing,” said
“I want to thank Greg, the Avadel team, and the
“The Board and I are committed to supporting the Avadel team through the NDA preparation and review process for FT218. Since joining the Board, I have been actively overseeing the development and regulatory plan of FT218. I remain confident that the team is well positioned to finish the filing without delay,” stated
About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the
About
Footnote: 1. Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release,
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, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, 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).
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 (including, without limitation, the continued advancement and development of FT218 and benefits and cost savings from the sale of our hospital products) 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 risk that we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA or does not approve FT218, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and 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
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.
Contacts:
Investor Contacts
Chief Financial Officer
Phone: (636) 449-1843
Email: tmchugh@avadel.com
Phone: (212) 915.2564
Email: tim@lifesciadvisors.com
Media Contact
Phone: (646) 970-4688
Email: pbursey@lifescicomms.com
Source: Avadel Pharmaceuticals plc