WOODCLIFF LAKE, N.J. and
SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the
presentation of one oral presentation and one poster at Obesity
Week(SM) regarding new data on BELVIQ® (lorcaserin HCl)
CIV. Hosted by The Obesity Society and the American Society for
Metabolic and Bariatric Surgery, the meeting is taking place from
October 31-November 4, 2016, in
New Orleans, Louisiana at the
Morial Convention Center.
Presentations of note include:
Effects of Lorcaserin on Lipid Parameters in Patients With
Overweight or Obesity and Dyslipidemia
- Oral Presentation Number: T-OR-2070
- Session: Energy Balance: Causes and Consequences
- Presentation: 11/3/16; 3:45 pm –
5:15 pm
- Location: Ernest N. Morial Convention Center; Room 206-207
A post-hoc analysis that evaluated triglycerides (TG) and
non-high-density lipoprotein cholesterol (non-HDL-C) after
treatment with lorcaserin in a subset of patients without T2DM and
with dyslipidemia at baseline (defined as: Fasting TG ≥200 mg/dL
and/or non-HDL-C ≥160 mg/dL)
Health-Related Quality of Life in Randomized Controlled
Trials of lorcaserin for Obesity Management: What Mediates
Improvement?
- Poster Number: T-P3478
- Session: Pharmacological and Surgical Treatment of Obesity and
Others
- Presentation: 11/4/16; 12:00 pm –
1:30 pm
- Location: Ernest N. Morial Convention Center; Exhibit Hall
A pooled analysis from three lorcaserin Phase 3 trials (BLOOM,
BLOSSOM and BLOOM DM) to determine whether lorcaserin is associated
with greater improvements in health-related quality of life and
whether these improvements are solely attributable to weight
loss.
This release discusses an investigational use for an
FDA-approved product. It is not intended to convey conclusions
about efficacy or safety. There is no guarantee that any
investigational uses of such product will successfully complete
clinical development or gain FDA approval.
INDICATION FOR BELVIQ® (lorcaserin HCl)
CIV
BELVIQ is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight management in adults
with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least
one weight-related comorbid condition (eg, hypertension,
dyslipidemia, type 2 diabetes).
Limitations of Use
- The safety and efficacy of coadministration of BELVIQ with
other products intended for weight loss, including prescription
drugs (eg, phentermine), over-the-counter drugs, and herbal
preparations, have not been established.
- The effect of BELVIQ on cardiovascular morbidity and mortality
has not been established.
IMPORTANT SAFETY INFORMATION
Contraindication
- BELVIQ should not be taken during pregnancy or by women who are
planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions have been reported during use of
serotonergic drugs, including, but not limited to, selective
serotonin-norepinephrine reuptake inhibitors, and selective
serotonin reuptake inhibitors, tricyclic antidepressants,
bupropion, triptans, dietary supplements such as St. John's Wort
and tryptophan, drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors), dextromethorphan,
lithium, tramadol, antipsychotics or other dopamine antagonists,
particularly when used in combination. Patients should be monitored
for the emergence of serotonin syndrome symptoms or NMS-like
reactions, including agitation, hallucinations, coma, tachycardia,
labile blood pressure, hyperthermia, hyperreflexia, incoordination,
nausea, vomiting, diarrhea, and muscle rigidity. Treatment with
BELVIQ and any concomitant serotonergic or antidopaminergic agents
should be discontinued immediately if the above events occur, and
supportive symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that
have been associated with valvular heart disease (eg, cabergoline).
In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of
patients taking placebo developed valvular regurgitation: none of
these patients were symptomatic. BELVIQ should be used with caution
in patients with congestive heart failure (CHF). Patients who
develop signs and symptoms of valvular heart disease, including
dyspnea, dependent edema, CHF, or a new cardiac murmur, should be
evaluated and discontinuation of BELVIQ should be considered.
- Impairment in attention, memory, somnolence, confusion, and
fatigue, have been reported in patients taking BELVIQ. Patients
should not drive a car or operate heavy machinery until they know
how BELVIQ affects them.
- The recommended dose of 10 mg twice daily should not be
exceeded, as higher doses may cause euphoria, hallucination, and
dissociation. Monitor patients for the development or worsening of
depression, suicidal thoughts or behaviors, and/or any changes in
mood. Discontinue BELVIQ in patients who develop suicidal thoughts
or behaviors.
- Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus who are being treated with
antidiabetic medications, so measurement of blood sugar levels
before and during treatment with BELVIQ is recommended. Decreases
in doses of antidiabetic medications or changes in medication
regimen should be considered.
- Men who experience priapism should immediately discontinue
BELVIQ and seek emergency medical attention. BELVIQ should be used
with caution with erectile dysfunction medications. BELVIQ should
be used with caution in men who have conditions that might
predispose them to priapism (eg, sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (eg, angulation, cavernosal fibrosis, or Peyronie's
disease).
- Because BELVIQ may cause a slow heartbeat, it should be used
with caution in patients with a history of bradycardia or heart
block greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and
pulmonary hypertension.
Most Common Adverse Reactions (>5% and more common than
placebo)
- In patients without diabetes: headache (17%), dizziness (9%),
fatigue (7%), nausea (8%), dry mouth (5%), and constipation
(6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%),
back pain (12%), cough (8%), and fatigue (7%).
Nursing Mothers
- BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may
be abused or lead to dependence.
For more information about BELVIQ, see full
Prescribing Information.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our
goal. We give our first thoughts to patients and their families,
and helping to increase the benefits health care provides. As the
U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd.,
we have a passionate commitment to patient care that is the driving
force behind our efforts to discover and develop innovative
therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that
operates in two global business groups: oncology and neurology
(dementia-related diseases and neurodegenerative diseases). Each
group functions as an end-to-end global business with discovery,
development, and marketing capabilities. Our U.S. headquarters,
commercial and clinical development organizations are located
in New Jersey; our discovery labs are
in Massachusetts and Pennsylvania; and our global
demand chain organization resides
in Maryland and North Carolina. To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
About Arena Pharmaceuticals
We are a biopharmaceutical company focused on developing novel,
small molecule drugs across a range of therapeutic areas. We
have three primary proprietary investigational clinical programs:
etrasimod (APD334) in Phase 2 evaluation for ulcerative colitis,
APD371 entering Phase 2 evaluation for the treatment of pain
associated with Crohn's disease, and ralinepag (APD811) in Phase 2
evaluation for pulmonary arterial hypertension (PAH).
Additionally, we have collaborations with the following
pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc.
(commercial stage), Axovant Sciences Ltd. (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
Our US operations are located in San
Diego, California. Our primary clinical operations are
located in Zug, Switzerland, and
our commercial manufacturing for BELVIQ is located in Zofingen,
Switzerland.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademarks 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 therapeutic
potential of BELVIQ; the need to address obesity; Eisai's
commitment; and Arena's focus, plans, goals, strategy,
expectations, research and development programs, and ability to
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: risks related to
commercializing drugs, including regulatory, manufacturing, supply
and marketing issues and the availability and use of BELVIQ; cash
and revenues generated from BELVIQ; Arena may need additional funds
to advance all of its programs, and you may not agree with the
manner Arena allocates its resources; 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 BELVIQ may not receive any
additional marketing approvals; regulatory decisions in one
territory may impact other regulatory decisions and Arena's
business prospects; government and commercial reimbursement and
pricing decisions; risks related to relying on collaborative
arrangements; the timing and receipt of payments and fees, if any,
from collaborators; the entry into or modification or termination
of collaborative arrangements; 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; Arena's and third parties' intellectual
property rights; the timing, success and cost of Arena's research
and development and related strategy and decisions; 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; 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.
Contacts: Eisai
Inc.
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Media
Inquiries
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Investor
Inquiries
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Laurie
Landau
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Ivor
Macleod
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Eisai
Inc.
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Eisai Inc.
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201-746-2510
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201-746-2660
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Contact: Arena
Pharmaceuticals,
Inc.
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Kevin R. Lind, Chief
Financial
Officer
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klind@arenapharm.com
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858-453-7200, ext.
1716
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Eisai Inc.