Avadel Pharmaceuticals Expands Leadership Team with Three Strategic Hires
02 6월 2021 - 9:00PM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218, an investigational, once-nightly formulation of
sodium oxybate for treating excessive daytime sleepiness and
cataplexy in adults with narcolepsy, announced today it has
appointed Jeff Cruikshank as Vice President, Sales; Denise Strauss
as Vice President, Marketing and New Product Strategy; and Angela
Woods as Vice President, People and Culture.
These newly-created roles will continue to build the Company’s
capabilities to support the potential approval and
commercialization of once-nightly FT218. As Vice President, Sales,
Mr. Cruikshank will lead the development of Avadel’s
go-to-market customer model including the buildout and deployment
of the Company’s patient-focused sales team. Ms. Strauss, Vice
President, Marketing and New Product Strategy, will be responsible
for the market preparation and launch of FT218, future new product
strategy, and building out the marketing team. Ms. Woods as Vice
President, People and Culture, will lead the Company’s human
resources function, and will be responsible for implementing
strategies that support the growth of the organization and
cultivating a culture reflective of its vision and core values.
“We believe once-nightly FT218 has the potential to truly impact
the way people with narcolepsy are able to live their lives. As we
accelerate our launch preparations and commercialization strategy
ahead of the anticipated U.S. regulatory approval, we are thrilled
to welcome these three talented biopharma leaders to our growing
team,” said Greg Divis, Chief Executive Officer of Avadel. “Jeff,
Denise and Angela each bring diverse experience to Avadel. Their
collective expertise launching innovative therapies in competitive
markets and scaling organizations will be invaluable as we progress
toward our shared vision of making FT218 available to patients
seeking a new treatment option for managing the relentless daytime
and nighttime symptoms of narcolepsy.”
New Avadel Leadership Team Members
- Jeff Cruikshank, Vice President, Sales, is an
accomplished leader with more than two decades of experience in
sales and marketing, product launches and brand building across
various therapeutic areas in both emerging and competitive markets.
Prior to joining Avadel, Mr. Cruikshank held positions of
increasing leadership in sales and commercial training at Ironwood
Pharmaceuticals, Novartis, and Janssen Pharmaceuticals. He earned a
bachelor’s degree in business administration in management from
East Tennessee State University in Johnson City.
- Denise Strauss, Vice President, Marketing and
New Product Strategy, is an industry-leading biopharmaceutical
marketer who has successfully launched more than a dozen products
and devices in a variety of therapeutic areas, for companies
including Genfit, Pfizer, Schering-Plough and Boehringer Ingelheim.
During her career, she has been responsible for leading marketing
strategy and execution across billion-dollar brands and
multi-billion-dollar portfolios. She earned a B.S. in communication
from Cornell University and an MBA in marketing from Pace
University.
- Angela Woods, Vice President, People and
Culture, is a highly regarded human resources executive with a
track record for growing successful, high-performing teams spanning
multiple industries, global organizations and diverse
workforces. Prior to joining Avadel, she served as Vice
President, Human Resources, at Mallinckrodt Pharmaceuticals, where
she oversaw the development of talent strategies in support of the
company’s new product launches, multiple M&A integrations,
culture building and business transformation. She earned a B.S. in
finance from Southern Illinois University at Carbondale.
About FT218FT218 is an investigational,
once-nightly formulation of sodium oxybate that includes Avadel’s
MicroPump™ controlled-release technology. 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. In
December 2020, the Company submitted a NDA to the FDA for FT218 to
treat excessive daytime sleepiness and cataplexy in adults with
narcolepsy. The NDA for FT218 was accepted by the FDA in February
2021 and assigned a PDUFA target action date of October 15, 2021.
FT218 has been granted Orphan Drug Designation from the FDA for the
treatment of narcolepsy. The designation was granted on the
plausible hypothesis that FT218 may be clinically superior to the
twice-nightly formulation of sodium oxybate already approved by the
FDA for the same indication. In particular, FT218 may be safer due
to ramifications associated with the dosing regimen of the
previously approved product.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical
company primarily focused on the development and FDA approval of
FT218, an investigational, once-nightly, extended-release
formulation of sodium oxybate designed to treat 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 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
FDA’s review of the NDA for FT218, the sufficiency of data
supporting the NDA for FT218, the presentation of additional
clinical trial data for FT218, the commercial launch, including
timing and success of FT218 (if approved), the market acceptance of
FT218 (if approved), and the anticipated contribution of the new
hires of the Company to its success and progress. 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 risk that: the NDA for FT218
is not approved by the FDA or such approval is delayed; the risk
that commercial launch of FT218 (if approved) is delayed or never
occurs; the risk that the potential market acceptance of FT218 (if
approved) may differ materially from projections; and the risk that
the impact of the current COVID-19 pandemic on the Company’s
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 the Company’s Annual
Report on Form 10-K for the year ended December 31, 2020, which was
filed with the Securities and Exchange Commission (SEC) on March 9,
2021 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:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com(408)
568-4292
Avadel Pharmaceuticals (NASDAQ:AVDL)
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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