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/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.
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
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. 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 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.
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, 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 law.
Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Craig Audet, 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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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.