SAN DIEGO, June 13, 2016 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the
United States Adopted Names (USAN) Council has approved the
nonproprietary name etrasimod (pronounced Et-ras'-i-mod) for
APD334, a selective oral, investigational, Sphingosine 1-Phosphate
Subtype 1 (S1P1) receptor modulator with therapeutic
potential in autoimmune diseases. Arena is currently studying
etrasimod in a Phase 2 clinical trial for ulcerative colitis.
"Given the limitations of currently available treatments for
ulcerative colitis, including challenging effect profiles, we
believe etrasimod has the potential to become the standard of
care," said Amit Munshi, President
and Chief Executive Officer of Arena. "We look forward to the
results of our Phase 2 clinical trial of this promising
compound."
Etrasimod is a potent and highly selective, orally available
investigational drug candidate that targets the S1P1
receptor. S1P1 receptors have been demonstrated to be
involved in the modulation of several biological responses,
including lymphocyte trafficking from lymph nodes to the peripheral
blood. By isolating subpopulations of lymphocytes in lymph nodes,
fewer immune cells are available in the circulating blood to effect
tissue damage.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease that affects the large
intestine. The innermost lining of the large intestine becomes
inflamed and ulcers may form on the surface, which can cause
symptoms such as frequent bowel movements, diarrhea and bloody
stools. The inflammation is usually found in the rectum and can
include all or a portion of the colon. Currently available
treatment options have limitations in terms of side effects,
patient response, efficacy and administration. Arena believes that
an effective, orally available S1P1 receptor modulator
that provides clinical benefits without current limitations has the
potential to improve treatment for patients with ulcerative
colitis.
About the USAN Council
The USAN Council, tri-sponsored by the American Medical
Association, the United States Pharmacopeial Convention and the
American Pharmacists Association, serves the health professions in
the United States by selecting
simple, informative and unique nonproprietary names for drugs by
establishing logical nomenclature classifications based on
pharmacological and/or chemical relationships. The USAN Council
aims for global standardization and unification of drug
nomenclature and related rules to ensure that drug information is
communicated accurately and unambiguously, working closely with the
World Health Organization's International Nonproprietary Name
Programme and various national nomenclature groups.
About Arena Pharmaceuticals
We are a biopharmaceutical company focused on discovering and
developing novel, small molecule drugs. We are currently directing
our activities and resources primarily on the following
activities:
- Advancing our proprietary clinical programs:
- Etrasimod (APD334) – a next generation, highly specific
modulator of Sphingosine 1-Phosphate Subtype 1 (S1P1)
receptor – in an ongoing Phase 2 clinical trial for ulcerative
colitis, and potentially exploring additional indications,
including beyond inflammatory bowel disease
- Ralinepag (APD811) – an agonist of the prostacyclin receptor –
in an ongoing Phase 2 clinical trial for pulmonary arterial
hypertension (PAH)
- APD371 – an agonist of the cannabinoid-2 (CB2)
receptor – most recently completed a Phase 1 multiple-ascending
dose clinical trial with favorable results, and is under evaluation
for pain indications
- Supporting our collaborations:
- Eisai Inc. and Eisai Co., Ltd. and others – in their
efforts with respect to the approved product BELVIQ for weight
management
- Axovant Sciences Ltd. – in Phase 2 clinical trials for
nelotanserin, an inverse agonist of the serotonin 2A receptor for
central nervous system disorders
- Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial
for temanogrel, an inverse agonist of the serotonin 2A receptor for
thrombotic diseases
- Boehringer Ingelheim International GmbH – in preclinical
development of drug candidates targeting a central nervous system
(CNS) receptor for psychiatric diseases
Our US operations are located in San
Diego, California, and our operations outside of
the United States, including our
commercial manufacturing facility, are located in Zofingen,
Switzerland. For more information,
visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements include statements about the
advancement, therapeutic indication, safety, efficacy, mechanism of
action and promise of etrasimod, including relative to other
therapies and its potential to become the standard of care; the
future study of etrasimod, including in the ongoing Phase 2
clinical trial for ulcerative colitis, and receiving results of
such study; the potential of an effective, orally available
S1P1 receptor modulator; the direction of Arena's
activities and resources, including with respect to advancing
clinical programs and supporting collaborations; and Arena's focus,
plans, goals, strategy, expectations, research and development
programs, and ability to discover and develop compounds and
commercialize drugs. 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, but are not
limited to, the following: having adequate funds and other
resources and their effective use; enrollment in the ongoing Phase
2 clinical trials of etrasimod and ralinepag is competitive and
challenging, and their progress, completion and results are
uncertain; recruiting and retaining effective management and other
key employees; risks related to commercializing drugs, including
regulatory, product supply, marketing and use; the focus, efforts
and decisions of collaborators; the entry into, modification or
termination of collaborative arrangements, and risks related to
relying on such arrangements; the timing and receipt of payments
from others; the risk that Arena's revenues are based in part on
estimates, judgment and accounting policies, and incorrect
estimates or disagreement regarding estimates or accounting
policies may result in changes to Arena's guidance or previously
reported results; the timing and outcome of regulatory review is
uncertain, and lorcaserin may not receive any additional marketing
approvals; regulatory decisions in one territory may impact other
regulatory decisions and Arena's business prospects; reimbursement
and pricing decisions; the timing, success and cost of Arena's
research and development; results of clinical trials and other
studies are subject to different interpretations and may not be
predictive of future results; clinical trials and other studies may
not proceed at the time or in the manner expected or at all;
unexpected or unfavorable new data; nonclinical and clinical data
is 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; data and other information
related to any of Arena's research and development may not meet
regulatory requirements or otherwise be sufficient for (or Arena or
a collaborator may not pursue) further research and development,
regulatory review or approval or continued marketing; intellectual
property rights; and satisfactory resolution of litigation or other
disagreements. 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.
Contact: Arena
Pharmaceuticals, Inc.
|
|
Craig M. Audet,
Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
|
|
www.arenapharm.com
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-usan-approval-of-nonproprietary-name-etrasimod-for-its-drug-candidate-apd334-300283276.html
SOURCE Arena Pharmaceuticals, Inc.