Arena Pharmaceuticals Reports that Eisai Completes Planned Increase in Sales
Force for BELVIQ® (lorcaserin HCl) CIV
-- Sales Force Increased to Approximately 600 Sales Specialists --
SAN DIEGO, July 10, 2014
SAN DIEGO, July 10, 2014 /PRNewswire/ --Arena Pharmaceuticals, Inc. (NASDAQ:
ARNA) today reported that Eisai Inc. has completed its planned increase of
more than 200 new contract sales representatives in its Metabolic Business
Unit, increasing the sales force for BELVIQ® by 50% to approximately 600.
Eisai expects this expansion of the sales force will enable them to increase
their reach to approximately 92,000 physicians in the United States.
"We are enthusiastic about the commercial ramp-up for BELVIQ with this further
increase in the sales force," said Jack Lief, Arena's President and Chief
Executive Officer. "This involves a large-scale deployment of additional sales
representatives who will increase Eisai's ability to educate physicians. We
support the approach and believe that it will help produce greater results."
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/m^2 or greater (obese), or 27 kg/m^2 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.
Eisai is responsible for the marketing and distribution of BELVIQ in the
United States under its agreement with Arena.
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 marketing and supply agreement for BELVIQ 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
oBELVIQ should not be taken during pregnancy or by women who are planning
to become pregnant.
Warnings and Precautions
oBELVIQ 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.
oPatients 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.
oImpairment 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.
oThe 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.
oWeight 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.
oMen 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).
oBecause BELVIQ may cause a slow heartbeat, it should be used with caution
in patients with a history of bradycardia or heart block greater than
oConsider monitoring for CBC changes, prolactin excess, and pulmonary
Most Common Adverse Reactions in Clinical Trials
oIn patients without diabetes: headache (17%), dizziness (9%), fatigue
(7%), nausea (8%), dry mouth (5%), and constipation (6%).
oIn patients with diabetes: hypoglycemia (29%), headache (15%), back pain
(12%), cough (8%), and fatigue (7%).
oBELVIQ 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.
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 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
Arena Pharmaceuticals® and Arena®are registered service marks of Arena
Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena
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 commercial ramp-up for BELVIQ; the sales force for BELVIQ,
including the deployment of additional representatives, and related results
and other expectations; Eisai's physician reach and education; 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 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
Contact:Arena Pharmaceuticals, Inc. Media Contact: Russo Partners
Craig Audet, Senior Vice President, David Schull, President
Operations and Head of Global Regulatory email@example.com
858.453.7200, ext. 1612
SOURCE Arena Pharmaceuticals, Inc.
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