WOODCLIFF LAKE, N.J. and
SAN DIEGO, Oct. 3, 2016 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced the
availability of BELVIQ XR® (lorcaserin HCl) CIV
extended-release 20 mg tablets, a new once-daily dosing option that
may help some patients achieve and maintain weight loss.
"With more than 78 million adults who are obese in this country
and obesity rates on the rise, there is an increased need for
additional therapeutic options to help patients better manage their
weight," said Caroline Apovian,
M.D., Professor of Medicine at Boston
University School of Medicine. "A once-daily,
extended-release tablet provides a treatment regimen that may help
patients meet their weight loss goals."
BELVIQ XR is proven to be slowly absorbed in the body and last
throughout the day. The 20 mg once-daily extended-release
formulation is approved for use with 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 XR, when taken with other prescription, over-the-counter, or
herbal weight-loss products, is safe and effective. It is not known
if BELVIQ XR changes your risk of heart problems, stroke or death
due to heart problems or stroke.
"We are pleased that BELVIQ XR is now available to patients and
may provide them with a new option that can be used as part of
their weight management armamentarium," said Amit Munshi, President and Chief Executive
Officer, Arena Pharmaceuticals, Inc."The launch of this new
formulation is another example of Arena's success in supporting our
collaborators."
"Eisai is committed to those living with obesity—a chronic,
progressive disease that has serious health consequences," said
Paul Hawthorne, Senior Vice
President, Neurology Business Group, Eisai Inc. "We are excited to
offer patients a once-daily option for chronic weight management
that may help them achieve and sustain their weight loss
goals."
For those who qualify, including those with Medicare Part D
coverage (restrictions apply), Eisai will also offer a savings
card, with two ways to save money on prescriptions. For more
information about the program, patients can visit www.belviqxr.com
or call 1(855) BELVIQ-1 (1-855-235-8471).
What are BELVIQ® and BELVIQ
XR®?
BELVIQ® (lorcaserin HCl) CIV and BELVIQ
XR® are FDA-approved prescription weight-loss
medications that, when used with diet and exercise, can help some
overweight (Body Mass Index [BMI] ≥27 kg/m²) adults with a
weight-related medical problem, or obese (BMI ≥30 kg/m²) adults,
lose weight and keep it off.
It is not known if BELVIQ or BELVIQ XR when taken with other
prescription, over-the-counter, or herbal weight-loss products is
safe and effective. It is not known if BELVIQ or BELVIQ XR changes
your risk of heart problems, stroke, or death due to heart problems
or stroke.
Important Safety Information
- Pregnancy: Do not take if you are pregnant or planning
to become pregnant, as weight loss offers no potential benefit
during pregnancy and BELVIQ or BELVIQ XR may harm your unborn
baby.
- Hypersensitivity Reactions: Do not take if you are
allergic to either of these medicines or any of their
ingredients.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions: Before using, 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 lifethreatening side
effects if taken with BELVIQ or BELVIQ XR. 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 or BELVIQ XR 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 or BELVIQ XR, tell your healthcare provider if
you have or have had heart problems.
- Changes in attention or memory: BELVIQ or BELVIQ XR may
slow your thinking. You should not drive a car or operate heavy
equipment until you know how BELVIQ or BELVIQ XR affects you.
- Mental problems: Taking too much BELVIQ or BELVIQ XR 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 or BELVIQ XR. 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 or BELVIQ XR, stop taking BELVIQ or
BELVIQ XR and call your healthcare provider or go to the nearest
emergency room right away.
- Slow heartbeat: Both BELVIQ or BELVIQ XR may cause your
heart to beat slower.
- Decreases in blood cell count: BELVIQ or BELVIQ XR may
cause your red and white blood cell counts to decrease.
- Increase in prolactin: BELVIQ or BELVIQ XR 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 of BELVIQ or BELVIQ XR:
Headache, dizziness, fatigue, nausea, dry mouth, constipation,
cough, low blood sugar (hypoglycemia) in patients with diabetes,
and back pain.
- Nursing: BELVIQ or BELVIQ XR should not be taken while
breastfeeding.
- Drug interactions: Before taking BELVIQ or BELVIQ XR,
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 and BELVIQ XR are federally controlled substances (CIV)
because they may be abused or lead to drug dependence.
For more information about BELVIQ or BELVIQ XR talk to
your healthcare provider and see the full Product Information
for BELVIQ or BELVIQ XR.
You are encouraged to report negative side effects of
prescription drugs to the FDA.Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
About Eisai Inc.
At Eisai Inc., human health care (hhc) 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 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 the following
pharmaceutical companies: 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.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® and BELVIQ XR® 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 therapeutic
potential of BELVIQ and BELVIQ XR; the need to address obesity;
Eisai's commitment; and Arena's focus, plans, goals, strategy,
expectations, research and development programs, and ability to
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 and
BELVIQ XR; cash and revenues generated from BELVIQ and BELVIQ XR;
Arena may need additional funds to advance all of its programs, and
you may not agree with the manner Arena allocates its resources;
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 BELVIQ or
BELVIQ XR may not receive any additional marketing approvals;
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; 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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Media
Inquiries
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Investor
Inquiries
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Laurie
Landau
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Ivor
Macleod
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Eisai
Inc.
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Eisai Inc.
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201-746-2510
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201-746-2660
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Contact: Arena
Pharmaceuticals,
Inc.
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Kevin R. Lind, Chief
Financial
Officer
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klind@arenapharm.com
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858-453-7200, ext.
1716
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Eisai Inc.