WOODCLIFF LAKE, N.J. and
SAN DIEGO, Dec. 19, 2016 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that
Eisai Laboratórios Ltda., a subsidiary of Eisai Inc., has received
regulatory approval from the Brazilian Health Surveillance Agency
(ANVISA) for BELVIQ® (lorcaserin HCl) for chronic weight
management.
BELVIQ is approved in Brazil as
an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with a
body mass index (BMI) of 30 kg/m2 or greater (obese), or
overweight patients with a BMI greater than or equal to 27
kg/m2 in the presence of at least one weight-related
comorbid condition such as high blood pressure, high cholesterol,
cardiovascular disease, type 2 diabetes managed with oral
hypoglycemic agents or sleep apnea. The product is expected to
become available following review by Brazil's Medicines Market Regulation Board
(CMED), which will trigger a $1
million milestone payment to Arena.
"Currently, more than half of the Brazilian population is
overweight or obese and, without intervention, these numbers are
projected to increase," said Shaji Procida, President and
Chief Operating Officer, Eisai Inc. "This approval represents a new
option for Brazilians who find it difficult to lose weight through
diet and exercise alone. At Eisai, we remain committed to help
address the needs of this patient population."
In addition to Brazil, BELVIQ
is approved for weight management in the
United States and South
Korea. Lorcaserin is also approved in Mexico under the brand name
VENESPRI® (lorcaserin HCl).
About BELVIQ® (lorcaserin HCl) CIV for Chronic
Weight Management in the United
States
BELVIQ is an FDA-approved prescription
weight-loss medication that, when used with diet and exercise, can
help some adults (body mass index [BMI] ≥27 kg/m2)
living with extra weight, with a weight-related medical problem, or
adults living with obesity (BMI ≥30 kg/m2), lose weight
and keep it off.
It is not known if BELVIQ when taken with other prescription,
over-the-counter, or herbal weight-loss products is safe and
effective. It is not known if BELVIQ changes your risk of heart
problems, stroke, or death due to heart problems or stroke.
For more information about BELVIQ in the United States, click here for the full
Product Information or visit www.BELVIQ.com.
Important Safety Information for BELVIQ® in
the United States
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.
Hypersensitivity: Do not take BELVIQ if you are allergic
to lorcaserin hydrochloride or any of the ingredients in
BELVIQ.
Serotonin Syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions: Before using BELVIQ, tell your Healthcare
Provider 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 Healthcare Provider 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 Healthcare
Provider 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 Healthcare Provider 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
Healthcare Provider 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
Healthcare Provider 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 Healthcare Provider
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
Healthcare Provider 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.
For more information about BELVIQ®, talk to
your Healthcare Provider and see the full Product
Information.
About Eisai Laboratorios
Eisai Laboratórios Ltda. is a
pharmaceutical company dedicated to providing new treatment options
to patients and their families living in Brazil. As a part of the global network of
Eisai companies, it plays a key role in Eisai's effort to help
improving the lives of patients and families worldwide.
Eisai Laboratórios Ltda. is a part of Eisai's Americas
operations, which also include companies in Mexico, Canada and the
United States. Eisai Laboratórios Ltda., located in São
Paulo, Brazil, is a subsidiary of
Eisai Inc. a company based in the United
States.
About Eisai Inc.
At Eisai Inc., human health care
(hhc) is our goal. We give our first thought 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 and follow us
on Twitter and LinkedIn.
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 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.
For more information, visit Arena's website at
www.arenapharm.com.
Arena Pharmaceuticals® and
Arena® are registered service marks of Arena
Pharmaceuticals, Inc. BELVIQ®, BELVIQ
XR® and VENESPRI® are 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 expected availability and commercialization of
lorcaserin; the achievement of a milestone; the projected increase
in the population that is overweight or obese; Eisai's commitment;
Arena's focus, plans and strategy; the advancement and potential of
Arena's clinical programs and collaborations; and activities with
Eisai and other collaborators. 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 and
developing drugs; the risk that we may need additional funds to
advance all of our programs, and you and others may not agree with
the manner we allocate our resources; 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 a different formulation or in any
other territory; 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;
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.
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SOURCE Eisai Inc.