WOODCLIFF LAKE, N.J. and
SAN DIEGO, July 29, 2014 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that
BELVIQ® (lorcaserin HCl) has been nominated by the
Galien Foundation and Awards Committee for the 2014 Prix Galien
USA Award in the Best
Pharmaceutical Agent category. BELVIQ was previously nominated for
this award in 2013.
"Eisai's commitment to patient care is the driving force behind
our efforts to help address unmet medical needs," said Frank Ciriello, Eisai's President, Global
Neurology Business Unit. "The Prix Galien USA Award recognizes the extensive research
necessary to develop innovative medicines to help increase the
benefits health care provides to patients and their families."
The Prix Galien USA Award is
considered one of the biomedical industry's top accolades. It
recognizes outstanding achievements in improving the human
condition through the development of innovative therapies. Nominees
are selected from among those medicines and devices approved by the
United States Food and Drug Administration (FDA) in the previous
five years.
"This nomination reflects Arena's mission to improve health by
bringing innovative medicines to patients," said Dominic P. Behan, Ph.D., D.Sc., Arena's
Executive Vice President and Chief Scientific Officer. "We are
honored to be a part of the community of those nominated for this
prestigious award."
The Prix Galien USA Award
ceremony will be held in New York
City on October 28, 2014.
About BELVIQ® (lorcaserin HCl) CIV
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.
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 FDA. Eisai markets and distributes
BELVIQ in the United States, and
Arena manufactures and supplies the finished commercial product
from its facility in Switzerland.
For more information about BELVIQ, click here for the full
FDA-approved Product Information or visit www.BELVIQ.com.
About Overweight and Obesity
Obesity has become a substantial, widespread problem with more
than 2 billion people worldwide overweight or obese. Approximately
two thirds of US adults are overweight or obese, and the
prevalence of obesity in the United
States has more than doubled in the past 30 years.
Many health organizations and authorities, including the American
Medical Association, Centers for Disease Control and Prevention and
the National Institutes of Health, now recognize obesity as a
chronic disease that needs to be treated.
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 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 http://us.eisai.com.
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 is focused on discovering, developing and
commercializing additional drugs to address unmet medical needs.
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 has granted exclusive marketing and distribution rights
for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for the United States and most other territories
worldwide.
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 therapeutic
indication, use, safety, efficacy, mechanism of action, and
potential of BELVIQ or lorcaserin; rights and obligations under the
marketing and supply agreement among Arena and Eisai; prevalence of
overweight and obesity and the need for treatment; addressing unmet
medical needs and improving the human condition; embracing the
challenge of improving health; seeking to bring innovative
medicines to patients; and Arena's mission, 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.
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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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations and Head
of Global Regulatory Affairs
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david.schull@russopartnersllc.com
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caudet@arenapharm.com
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858.717.2310
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858.453.7200, ext.
1612
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SOURCE Arena Pharmaceuticals, Inc.