WOODCLIFF LAKE, N.J. and
SAN DIEGO, June 4, 2015 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the
following poster regarding lorcaserin HCl will be presented at
American Diabetes Association's 75th Scientific Sessions
taking place June 5-9, 2015, in
Boston, Massachusetts:
Impact of Sulfonylurea Use on Weight Loss Achieved with
Lorcaserin
Poster Number: 299-LB
This post-hoc analysis evaluated the impact of sulfonylurea use
on weight loss and glycemic parameters achieved with lorcaserin in
patients with type 2 diabetes mellitus over 52 weeks.
About BELVIQ® (lorcaserin HCl) CIV for
Chronic Weight Management
Lorcaserin is marketed in the
United States under the brand name BELVIQ. BELVIQ is a
serotonin 2C receptor agonist approved as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management in adults who have a body mass index (BMI) of 30
kg/m2 or greater (obese), or BMI of 27 kg/m2
or greater (overweight) with at least one weight-related medical
condition such as high blood pressure, high cholesterol, or type 2
diabetes. It is not known if BELVIQ is safe and effective when
taken with other prescription, over-the-counter, or herbal weight
loss products, nor is it known if BELVIQ changes the risk of heart
problems or stroke, or death due to heart problems or stroke.
BELVIQ is also approved for weight management in South Korea.
For more information about BELVIQ,
click here for the full Product
Information or visit
www.BELVIQ.com.
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 (e.g.,
cabergoline). In clinical trials, 2.4% of patients taking BELVIQ
and 2.0% of patients taking placebo developed valvular
regurgitation: none of these patients was 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 (e.g., sickle cell anemia,
multiple myeloma, or leukemia), or in men with anatomical
deformation of the penis (e.g., 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
- 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.
About Eisai Inc.
At Eisai Inc., human health care 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 help address unmet medical needs. We are a
fully integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at
www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global
product creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
manufacturing facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's focus is discovering, developing
and commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first
internally discovered drug approved for marketing. Arena's
US operations are located in San Diego,
California, and its operations outside of the United States, including its 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 marketing, therapeutic indication, use, safety, efficacy,
mechanism of action and potential of BELVIQ or lorcaserin;
embracing the challenge of improving health; seeking to bring
innovative medicines to patients; 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: risks
related to commercializing drugs, including regulatory,
manufacturing, supply and marketing issues and the availability and
use of BELVIQ or lorcaserin; cash and revenues generated from
BELVIQ, including the impact of competition; 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 be approved
for marketing in combination with another drug, for another
indication or using a different formulation or in any other
territory for any indication; 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; 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; having adequate
funds; 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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Investor
Inquiries:
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Media
Inquiries:
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Alex Scott
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Laurie
Landau
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alex_scott@eisai.com
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Laurie_Landau@eisai.com
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201.746.2177
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201.746.2510
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Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Scott A.
Rieger
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David
Schull
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Senior Director,
Investor Relations
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President
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srieger@arenapharm.com
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david.schull@russopartnersllc.com
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858.453.7200, ext.
1374
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858.717.2310
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www.eisai.com/US
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www.arenapharm.com
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To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lorcaserin-hcl-data-to-be-presented-at-american-diabetes-associations-75th-scientific-sessions-300094326.html
SOURCE Arena Pharmaceuticals, Inc.; Eisai Inc.