Lorcaserin HCl Data to be Presented at American Diabetes Association's 74th
WOODCLIFF LAKE, N.J. and SAN DIEGO, Calif., June 9, 2014
WOODCLIFF LAKE, N.J. and SAN DIEGO, Calif., June 9, 2014 /PRNewswire/ --Eisai
Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that data
from the Phase 3 clinical trial program for BELVIQ^® (lorcaserin HCl) CIV
will be presented at the American Diabetes Association's (ADA) 74th Scientific
Sessions taking place June 13-17, 2014 in San Francisco, California.
"Eisai is committed to advancing knowledge about the treatment of obesity, a
chronic, progressive disease that has serious health consequences," says Lynn
Kramer, MD, President of the Neuroscience and General Medicine Product
Creation Unit and Chief Clinical Officer of Eisai Company Ltd. "These data
presentations support Eisai's efforts to foster a greater understanding of
obesity and lorcaserin among the health care community."
BELVIQ is a serotonin 2C receptor agonist approved in the United States 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/m^2 or
greater (obese), or BMI of 27 kg/m^2 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.
The following presentation and abstracts will be presented at this year's ADA
Saturday, June 14 at 9:00 am PDT
oLorcaserin Can Improve Weight Loss in Patients with Prediabetes and Reduce
Progression to Diabetes in Obese and Overweight Patients
oAbstract Number: 99-OR
oSession: New Developments in Clinical Obesity
This post-hoc analysis evaluated the progression from prediabetes (defined
as either HbA1C 5.7 – 6.4 or fasting plasma glucose 100 – 125 mg/dL) at
baseline to diabetes over one year in lorcaserin- and placebo-treated adults
on a standardized program of diet and exercise.
Sunday, June 15 from 12:00 – 2:00 pm PDT
oChange in A1C in Overweight Patients with Type 2 Diabetes with the Healthy
Lifestyle Program Used in the Lorcaserin Phase 3 Trials
oAbstract Number: 2041-P
This analysis assessed the impact of the Healthy Lifestyle Program and its
potential for use as a support model applicable for practitioners who
provide care to overweight and obese patients with type 2 diabetes.
oLorcaserin Free Plasma Levels at Recommended Dose are Sufficient to
Activate Serotonin 2C but not 2A or 2B Receptors
oAbstract Number: 2039-P
This analysis compared in vivo plasma free lorcaserin and estimated brain
concentrations and in vitro half maximal effective concentration (EC50)
values needed for activation of serotonin 2 receptors.
About BELVIQ^® (lorcaserin HCl) CIV
BELVIQ is believed to decrease food consumption and promote satiety by
selectively activating serotonin 2C receptors in the brain. The exact
mechanism of action of BELVIQ is not known.
BELVIQ is approved by the U.S. Food and Drug Administration. Eisai markets and
distributes BELVIQ in the United States, and Arena manufactures and supplies
the finished commercial product from its facility in Switzerland. Eisai and
Arena's marketing and supply agreement for BELVIQ covers most territories
For more information about BELVIQ, click here for the full U.S. FDA-approved
Product Information or visit www.BELVIQ.com.
Important Safety Information
oPregnancy: Do not take BELVIQ if you are pregnant or planning to become
pregnant, as weight loss offers no potential benefit during pregnancy and
BELVIQ may harm your unborn baby.
oSerotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions:
Before using BELVIQ, tell your doctor about all the medicines you take,
especially medicines that treat depression, migraines, mental problems, or
the common cold. These medicines may cause serious or life-threatening
side effects if taken with BELVIQ. Call your doctor right away if you
experience agitation, hallucinations, confusion, or other changes in
mental status; coordination problems; uncontrolled muscle spasms; muscle
twitching; restlessness; racing or fast heartbeat; high or low blood
pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
oValvular heart disease: Some people taking medicines like BELVIQ have had
heart valve problems. Call your doctor right away if you experience
trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness,
fatigue, or weakness that will not go away; or fast or irregular
heartbeat. Before taking BELVIQ, tell your doctor if you have or have had
oChanges in attention or memory: BELVIQ may slow your thinking. You should
not drive a car or operate heavy equipment until you know how BELVIQ
oMental problems: Taking too much BELVIQ may cause hallucinations, a
feeling of being high or in a very good mood, or feelings of standing
outside your body.
oDepression or thoughts of suicide: Call your doctor right away if you
notice any mental changes, especially sudden changes in your mood,
behaviors, thoughts, or feelings, or if you have depression or thoughts of
oLow blood sugar: Weight loss can cause low blood sugar in people taking
medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood
sugar levels should be checked before and while taking BELVIQ. Changes to
diabetes medication may be needed if low blood sugar develops.
oPainful erections: If you have an erection lasting more than 4 hours while
on BELVIQ, stop taking BELVIQ and call your doctor or go to the nearest
emergency room right away.
oSlow heartbeat: BELVIQ may cause your heart to beat slower.
oDecreases in blood cell count: BELVIQ may cause your red and white blood
cell counts to decrease.
oIncrease in prolactin: BELVIQ may increase the amount of a hormone called
prolactin. Tell your doctor if your breasts begin to make milk or a milky
fluid, or if you are a male and your breasts increase in size.
oMost common side effects in patients without diabetes: Headache,
dizziness, fatigue, nausea, dry mouth, and constipation.
oMost common side effects in patients with diabetes: Low blood sugar,
headache, back pain, cough, and fatigue.
oNursing: BELVIQ should not be taken while breastfeeding.
oDrug interactions: Before taking BELVIQ, tell your doctor if you take
medicines for depression, migraines, or other medical conditions, such as:
triptans; medicines used to treat mood, anxiety, psychotic or thought
disorders, including tricyclics, lithium, selective serotonin reuptake
inhibitors, selective serotonin-norepinephrine reuptake inhibitors,
monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid
(an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC)
common cold/cough medicine); OTC supplements such as tryptophan or St.
John's Wort; or erectile dysfunction medicines.
BELVIQ is a federally controlled substance (CIV) because it may be abused or
lead to drug dependence.
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 internally discovered drug, BELVIQ^® (lorcaserin HCl), is approved in
the United States, and Arena is focused on discovering, developing and
commercializing additional drugs to address unmet medical needs. Arena's U.S.
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
Arena Pharmaceuticals^® and Arena^® are registered service marks of Arena
Pharmaceuticals, Inc. BELVIQ^® is a registered trademark of Arena
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
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, use, safety,
efficacy, mechanism of action, commercialization and potential of BELVIQ or
lorcaserin; the results, meaning and significance of the data analyses and
related presentations; Eisai's commitment and efforts, including with respect
to advancing knowledge, fostering a greater understanding, commitment to
patient care and addressing unmet medical needs; 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 Arena's 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,
including the impact of competition; Arena's revenues will be 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 be approved for marketing
when expected or ever 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 ability to obtain and defend patents; 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
Media Inquiries Investor
Laurie Landau Alex Scott
Eisai Eisai Inc.
(201) (201) 746-2177
Arena Pharmaceuticals, Inc.
Media Inquiries Investor
David Schull Craig Audet, Ph.D.
President Senior Vice President,
firstname.lastname@example.org Operations and Head of Global
(858) 717-2310 Regulatory Affairs
(858) 453-7200 ext. 1612
SOURCE Eisai Inc.
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