SAN DIEGO, April 14, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported that Eisai Inc.
has launched a national television advertising campaign for
BELVIQ® (lorcaserin HCl), an FDA-approved prescription
treatment for chronic weight management. The initial advertisement,
which illustrates the struggles that many people face with hunger
and body weight, will air on Lifetime, Oxygen, AMC and numerous
other networks. BELVIQ is presented as a targeted approach to
weight loss, that, when combined with diet and increased activity,
may help patients lose weight and keep it off.
"Eisai continues to ramp up its sales and marketing initiatives
for BELVIQ as planned," said Jack Lief, Arena's President and Chief
Executive Officer. "This expanded outreach to consumers is designed
to raise awareness about the availability of BELVIQ as a treatment
option and encourage a productive dialogue between patients and
physicians about the health benefits of weight loss and whether
BELVIQ is right for them as part of a chronic weight management
program."
The television advertising campaign builds upon the national
print advertising campaign Eisai launched in October 2013. The television advertisement is
intended to encourage patients to talk to their doctor about
BELVIQ, including a free 15-day offer for the treatment, and direct
them to visit www.StartBELVIQnow.com or call 800.934.2096 to obtain
additional information. Once a patient obtains a prescription for
BELVIQ, he or she is eligible for BELIEVE EVERYDAY
SUPPORTSM, a customizable online program that provides
support and savings for patients.
To view the television advertisement and additional multimedia
content associated with this announcement, please click here.
BELVIQ is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight management in adult
patients with an initial body mass index (BMI) of 30
kg/m2 or greater (obese), or 27 kg/m2 or
greater (overweight) in the presence of at least one
weight-related, comorbid condition (e.g., hypertension,
dyslipidemia, 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, and the effect of BELVIQ on
cardiovascular morbidity and mortality has not been
established.
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 US 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 BELVIQ
marketing and supply agreement covers most territories worldwide.
For more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
IMPORTANT SAFETY INFORMATION
Contraindication
- BELVIQ should not be taken during pregnancy or by women who are
planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions have been reported during use of
serotonergic drugs, including, but not limited to, selective
serotonin-norepinephrine reuptake inhibitors, and selective
serotonin reuptake inhibitors, tricyclic antidepressants,
bupropion, triptans, dietary supplements such as St. John's Wort
and tryptophan, drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors), dextromethorphan,
lithium, tramadol, antipsychotics or other dopamine antagonists,
particularly when used in combination. Patients should be monitored
for the emergence of serotonin syndrome symptoms or NMS-like
reactions, including agitation, hallucinations, coma, tachycardia,
labile blood pressure, hyperthermia, hyperreflexia, incoordination,
nausea, vomiting, diarrhea, and muscle rigidity. Treatment with
BELVIQ and any concomitant serotonergic or antidopaminergic agents
should be discontinued immediately if the above events occur, and
supportive symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that
have been associated with valvular heart disease (e.g.,
cabergoline). In clinical trials, 2.4% of patients taking BELVIQ
and 2.0% of patients taking placebo developed valvular
regurgitation: none of these patients was symptomatic. BELVIQ
should be used with caution in patients with congestive heart
failure (CHF). Patients who develop signs and symptoms of valvular
heart disease, including dyspnea, dependent edema, CHF, or a new
cardiac murmur, should be evaluated and discontinuation of BELVIQ
should be considered.
- Impairment in attention, memory, somnolence, confusion, and
fatigue, have been reported in patients taking BELVIQ. Patients
should not drive a car or operate heavy machinery until they know
how BELVIQ affects them.
- The recommended dose of 10 mg twice daily should not be
exceeded, as higher doses may cause euphoria, hallucination, and
dissociation. Monitor patients for the development or worsening of
depression, suicidal thoughts or behaviors, and/or any changes in
mood. Discontinue BELVIQ in patients who develop suicidal thoughts
or behaviors.
- Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus who are being treated with
antidiabetic medications, so measurement of blood sugar levels
before and during treatment with BELVIQ is recommended. Decreases
in doses of antidiabetic medications or changes in medication
regimen should be considered.
- Men who experience priapism should immediately discontinue
BELVIQ and seek emergency medical attention. BELVIQ should be used
with caution with erectile dysfunction medications. BELVIQ should
be used with caution in men who have conditions that might
predispose them to priapism (e.g., sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (e.g., angulation, cavernosal fibrosis, or Peyronie's
disease).
- Because BELVIQ may cause a slow heartbeat, it should be used
with caution in patients with a history of bradycardia or heart
block greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and
pulmonary hypertension.
Most Common Adverse Reactions in Clinical Trials
- In patients without diabetes: headache (17%), dizziness (9%),
fatigue (7%), nausea (8%), dry mouth (5%), and constipation
(6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%),
back pain (12%), cough (8%), and fatigue (7%).
Nursing Mothers
- BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may
be abused or lead to dependence.
For more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. BELVIQ® (lorcaserin HCl), Arena's internally
discovered drug, is approved in the
United States and is under review for regulatory approval in
additional territories. 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 Pharmaceuticals® and Arena® are registered service marks
of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of
Arena Pharmaceuticals GmbH.
BELIEVE EVERYDAY SUPPORTSM is a servicemark of Eisai
Inc.
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 and potential of BELVIQ or lorcaserin,
including in helping patients; the outreach to consumers and
advertising campaign for BELVIQ, including size, scope, design,
intentions, significance and related expectations; the dialogue
between patients and physicians; the ramping up of Eisai's sales
and marketing initiatives; BELIEVE EVERYDAY SUPPORTSM,
including its availability and content; regulatory review and
approval, manufacture, supply, and marketing and distribution of
BELVIQ; embracing the challenge of improving health and bringing
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 actual results to differ materially from the forward-looking
statements include, but are not limited to, the following: the
scope and impact of the BELVIQ advertising campaign; 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.
Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
|
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & 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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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.