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/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.
The following presentation and abstracts will be presented at
this year's ADA meeting:
Oral Presentation
Saturday,
June 14 at 9:00 am PDT
- Lorcaserin Can Improve Weight Loss in Patients with Prediabetes
and Reduce Progression to Diabetes in Obese and Overweight Patients
- Abstract Number: 99-OR
- Session: 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.
Poster Presentations
Sunday,
June 15 from 12:00 – 2:00 pm
PDT
- Change in A1C in Overweight Patients with Type 2 Diabetes with
the Healthy Lifestyle Program Used in the Lorcaserin Phase 3 Trials
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.
- Lorcaserin Free Plasma Levels at Recommended Dose are
Sufficient to Activate Serotonin 2C but not 2A or 2B Receptors
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
worldwide.
For more information about BELVIQ, click here for the full U.S.
FDA-approved Product Information or visit www.BELVIQ.com.
Important Safety Information
- Pregnancy: 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.
- Serotonin 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.
- Valvular 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 heart problems.
- Changes in attention or memory: BELVIQ may slow your
thinking. You should not drive a car or operate heavy equipment
until you know how BELVIQ affects you.
- Mental 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.
- Depression 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 suicide.
- Low 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.
- Painful 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.
- Slow heartbeat: BELVIQ may cause your heart to beat
slower.
- Decreases in blood cell count: BELVIQ may cause your red
and white blood cell counts to decrease.
- Increase 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.
- Most common side effects in patients without diabetes:
Headache, dizziness, fatigue, nausea, dry mouth, and
constipation.
- Most common side effects in patients with diabetes: Low
blood sugar, headache, back pain, cough, and fatigue.
- Nursing: BELVIQ should not be taken while
breastfeeding.
- Drug 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 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.
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.
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, 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 law.
Eisai
Inc.
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Media
Inquiries
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Investor
Inquiries
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Laurie
Landau
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Alex Scott
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Eisai
Inc.
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Eisai Inc.
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laurie_landau@eisai.com
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alex_scott@eisai.com
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(201)
746-2510
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(201)
746-2177
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Arena
Pharmaceuticals, Inc.
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Media
Inquiries
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Investor
Inquiries
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David
Schull
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Craig Audet,
Ph.D.
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President
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Senior Vice
President,
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david.schull@russopartnersllc.com
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Operations and Head
of Global
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(858)
717-2310
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Regulatory
Affairs
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caudet@arenapharm.com
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(858) 453-7200 ext.
1612
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SOURCE Eisai Inc.