Trevi Therapeutics Announces the Hiring of Key Talent
14 October 2020 - 7:05AM
Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of Haduvio™ (nalbuphine ER) to treat serious
neurologically mediated conditions, today announced the appointment
of Shashank Rohatagi, Ph.D., as Vice President, Pharmacology and
Clinical Pharmacokinetics, Farrell Simon, Pharm.D., as Vice
President, Head of U.S. Marketing, and Katherine S. Takaki, Ph.D.,
as Vice President, Global Regulatory Affairs. Dr. Rohatagi will be
responsible for managing the supportive studies required to seek
regulatory approvals as well as all CMC-related activities, and
joins Trevi after senior roles at Metrum Research, Otsuka
Pharmaceuticals and Daiichi Sankyo. Dr. Simon will lead the
development and implementation of the commercial strategy for
Haduvio, and joins Trevi from Pfizer. Dr. Takaki will oversee
Trevi’s global regulatory strategies including interactions with
key regulatory authorities and leading any registration efforts for
Haduvio, and joins the Company after working at Iterum Therapeutics
and Bristol Myers Squibb.
“We are pleased to welcome Shashank, Farrell, and Kathy to our
management team as we move forward with Haduvio,” said Jennifer L.
Good, President and Chief Executive Officer. “Their extensive
backgrounds in various areas of the biopharmaceutical industry
should be invaluable to the success of Trevi as we continue to
advance Haduvio. We look forward to their insight as we work
towards providing treatment to those suffering from serious
conditions, such as chronic pruritus in patients with prurigo
nodularis and chronic cough in idiopathic pulmonary fibrosis which
currently have no approved therapies.”
Dr. Rohatagi brings his diverse experience in the pharmaceutical
industry and drug development to the Trevi team. As Senior
Principal Scientist for Clinical Pharmacology at Metrum Research
Group, he was responsible for providing strategic and operational
support for clinical pharmacology and regulatory issues across
therapeutic areas for various stages of drug development. Prior to
that, Dr. Rohatagi was Vice President of Data Sciences at Otsuka
managing the group that supported data analytics for all phases of
development and regulatory submissions. Dr. Rohatagi holds a Ph.D.
from the University of Florida in Pharmacokinetics/Pharmacodynamics
and an M.B.A from St. Joseph’s University.
Dr. Simon has a diverse set of experiences he brings to Trevi to
develop and execute commercialization plans for Haduvio. His career
spans both U.S. and global roles, where he has developed and
implemented numerous marketing and sales campaigns to increase
internal and external engagement. He is an experienced general
manager who has successfully led operating plans for brands of
varying size and worked across the lifecycle of products from
in-line brands to early commercial development assets. Prior to
joining Trevi, Dr. Simon most recently served as Chief of Staff to
the Group President of Biopharma at Pfizer and was a member of the
leadership team. In this role he led operations across seven
innovative business units, as well as led pan-business unit
strategic initiatives. He began his career at Procter & Gamble
and holds both an M.B.A. and a Pharm.D. from the University of
Florida.
Dr. Takaki joins Trevi with extensive pharmaceutical industry
experience in regulatory strategy, global project and team
management, and drug discovery. Before becoming part of Trevi, she
served as Vice President, Global Regulatory Affairs at Iterum
Therapeutics where she helped build out the regulatory group to
support the company’s regulatory strategy and operations. Prior to
that, Dr. Takaki held leadership positions at Bristol Myers Squibb
supporting multiple therapeutic areas. She was the global project
manager for the team that developed Baraclude for the treatment of
hepatitis B and launched it in markets worldwide. Her most recent
role at Bristol Myers was Group Director, Head of Regulatory
Strategy Marketed Products. She holds a Ph.D. in Organic Chemistry
from the Massachusetts Institute of Technology and a B.S. in
Chemistry from the University of Hawaii at Manoa.
About Trevi Therapeutics, Inc.Trevi
Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and commercialization of Haduvio
to treat serious neurologically mediated conditions. Trevi is
currently developing Haduvio for the treatment of chronic pruritus,
chronic cough in patients with idiopathic pulmonary fibrosis (IPF)
and levodopa-induced dyskinesia (LID) in patients with Parkinson’s
disease. These conditions share a common pathophysiology that is
mediated through opioid receptors in the central and peripheral
nervous systems. Trevi is currently conducting a Phase 2b/3
clinical trial of Haduvio, referred to as the PRISM trial, in
patients with severe pruritus associated with prurigo
nodularis.
Founded in 2011, Trevi Therapeutics is headquartered
in New Haven, CT.
About HADUVIOHaduvio is an oral extended
release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid
receptor agonist and µ-opioid receptor antagonist that has been
approved and marketed as an injectable for pain indications for
more than 20 years in the United States and Europe. The ĸ- and
µ-opioid receptors are known to be critical mediators of itch,
cough and certain movement disorders. Nalbuphine’s mechanism of
action also mitigates the risk of abuse associated with µ-opioid
agonists because it antagonizes, or blocks, µ-opioid receptors.
Nalbuphine is currently the only opioid approved for marketing that
is not classified as a controlled substance in the United States
and most of Europe. Trevi intends to propose Haduvio as the trade
name for the nalbuphine ER investigational product. Haduvio is an
investigational drug product and its safety and efficacy have not
been fully evaluated by any regulatory authority.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to risks and uncertainties and actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not
limited to, Trevi’s business plans and objectives, including future
plans or expectations for Trevi’s product candidates and
expectations regarding potential regulatory submissions; and other
statements containing the words “believes,” “anticipates,” “plans,”
“expects,” and similar expressions. Risks that contribute to the
uncertain nature of the forward-looking statements include:
uncertainties regarding the success, cost and timing of Trevi’s
product candidate development activities and ongoing and planned
clinical trials; uncertainties regarding the scope, timing and
severity of the COVID-19 pandemic, the impact of the COVID-19
pandemic on Trevi’s clinical operations and actions taken in
response to the pandemic; uncertainties regarding Trevi’s ability
to execute on its strategy; the risk that positive results from a
clinical trial may not necessarily be predictive of the results of
future or ongoing clinical trials; potential regulatory
developments in the United States and foreign countries;
uncertainties inherent in estimating our cash runway, future
expenses and other financial results; as well as other risks and
uncertainties set forth in the Company’s quarterly report on Form
10-Q for the quarter ended June 30, 2020 filed with the Securities
and Exchange Commission and in subsequent filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Trevi undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Investor ContactChris Seiter, Chief Financial
OfficerTrevi Therapeutics,
Inc.203-304-2499chris.seiter@trevitherapeutics.com
Media Contact
Rosalia
Scampoli914-815-1465rscampoli@marketcompr.com
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