SAN DIEGO, Jan. 16, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the U.S.
Food and Drug Administration (FDA) granted Fast Track designation
for APD418, a β3-adrenergic receptor (AdrR) antagonist
and cardiac myotrope, in development for the treatment of
decompensated heart failure (DHF).
"With approximately 10 million DHF patient hospital visits
expected in the US by 2025 and few viable treatment options, we
believe that APD418 has the potential to make a significant impact
for these patients," stated Chris
Cabell, MD, MHS, FACC, Arena's Senior Vice President and
Chief Medical Officer. "We are pleased with the Fast Track
designation and look forward to advancing this program as part of
our cardiovascular focus."
About APD418
APD418 is a first-in-class
β3-adrenergic receptor (AdrR) antagonist and cardiac
myotrope for decompensated heart failure (DHF). APD418 is a
selective antagonist designed to improve cardiac contractility with
minimal effect on heart rate, blood pressure and myocardial oxygen
consumption, thus potentially avoiding adverse events associated
with current inotrope therapies. Arena discovered and developed
this investigational drug candidate internally.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
uniquely positioned to develop best-in-disease medicines with
optimized efficacy and safety for patients globally. Our drive to
deliver a robust pipeline of novel, transformational medicines is
grounded in two decades of world class G-protein-coupled receptor
(GPCR) discovery research.
It is the breadth and depth of the portfolio, the prioritization
of drug development to meet unmet patient needs, the strong
financial health and the growing, bold-thinking world-class team
that gives Arena the ingredients and passion to build a
sustainable, vibrant next generation pharmaceutical company.
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. These forward-looking statements may be
identified by introductory words such as "expected", "potential",
"look forward", "designed to", "uniquely positioned to," "drive
to," "will", or words of similar meaning, or by the fact that they
do not relate strictly to historical or current facts. Such
forward-looking statements include statements about expected
patient hospital visits, the potential of our drug candidates, our
development programs, the potential of our drug candidates to
avoid adverse events, and Arena's position, including to develop
best-in-disease medicines, Arena's drive, portfolio,
prioritization, and financial position, and Arena's team, including
its growth, thinking, and ability to build the company. For such
statements, Arena claims the protection of the Private Securities
Litigation Reform Act of 1995. Actual events or results may differ
materially from Arena's expectations. Factors that could cause
actual results to differ materially from the forward-looking
statements include, without limitation, the following: Fast Track
designation may not result in an expedited regulatory review
process; the timing and outcome of research, development and
regulatory review is uncertain; clinical trials and other studies
may not proceed at the time or in the manner expected or at all;
enrolling subjects in our ongoing and intended clinical trials is
competitive and challenging; results of clinical trials and other
studies are subject to different interpretations and may not be
predictive of future results; nonclinical and clinical data are
voluminous and detailed, and regulatory agencies may interpret or
weigh the importance of data differently and reach different
conclusions than Arena or others, request additional information,
have additional recommendations or change their guidance or
requirements before or after approval; we expect to need additional
funds to advance all of our programs, and you and others may not
agree with the manner we allocate our resources; our drug
candidates may not advance in development or be approved for
marketing; risks related to unexpected or unfavorable new data;
risks related to relying on partners and other third parties; risks
related to developing and commercializing drugs; Arena's and third
parties' intellectual property rights; and satisfactory resolution
of litigation or other disagreements with others. Additional
factors that could cause actual results to differ materially from
those stated or implied by Arena's forward-looking statements are
disclosed in Arena's filings with the Securities and Exchange
Commission. These forward-looking statements represent Arena's
judgment as of the time of this release. Arena disclaims any intent
or obligation to update these forward-looking statements, other
than as may be required under applicable law.
Corporate Contact:
Kevin R.
Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Arena Media Contact:
IR@arenapharm.com
858-453-7200
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SOURCE Arena Pharmaceuticals, Inc.