WOODCLIFF LAKE, N.J. and
SAN DIEGO, July 30, 2014 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that an
article based on post-hoc analyses from the three pivotal Phase 3
trials of lorcaserin entitled, "Early Weight Loss While on
Lorcaserin, Diet, and Exercise as a Predictor of Week 52
Weight-Loss Outcomes," was recently published in the online issue
of Obesity, the official peer reviewed journal of The
Obesity Society. The objective of these analyses was to identify
whether there is an early treatment milestone that can predict
greater than or equal to 5% weight loss at one year in patients
treated with lorcaserin.
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ is a serotonin 2C receptor agonist approved in
the United States as an adjunct to
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. The safety and efficacy of coadministration of BELVIQ
with other products intended for weight loss, including
prescription drugs (e.g., phentermine), over-the-counter drugs, and
herbal preparations, have not been established. The effect of
BELVIQ on cardiovascular morbidity and mortality has not been
established.
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 (FDA).
Eisai markets and distributes BELVIQ in the United States, and Arena manufactures and
supplies the finished commercial product from its facility in
Switzerland.
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 (eg, cabergoline).
In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of
patients taking placebo developed valvular regurgitation: none of
these patients were 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 (eg, sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (eg, 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 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 that may
lead to abuse or dependence.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first
thoughts to patients and their families, and helping to increase
the benefits health care provides. As the US 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 help address unmet medical
needs. We are a fully integrated pharmaceutical business with
discovery, clinical, manufacturing and marketing capabilities. Our
key areas of commercial focus include oncology and specialty care
(Alzheimer's disease, epilepsy and metabolic disorders). To learn
more about Eisai Inc., please visit us at http://us.eisai.com.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
manufacturing facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
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 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 has granted exclusive marketing and distribution rights
for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for the United States and most other territories
worldwide.
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 therapeutic
indication, use, safety, efficacy, mechanism of action, and
potential of BELVIQ or lorcaserin; the significance of the post-hoc
analyses and their results; rights and obligations under the
marketing and supply agreement among Arena and Eisai; 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
Arena's 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.
Contacts: Eisai
Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Alex Scott
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Laurie
Landau
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alex_scott@eisai.com
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Laurie_Landau@eisai.com
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201.746.2177
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201.746.2510
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Contact: Arena
Pharmaceuticals, Inc.
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Craig M. Audet,
Ph.D., 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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SOURCE Arena Pharmaceuticals, Inc.