WOODCLIFF LAKE, N.J. and
SAN DIEGO, Nov. 18, 2013 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that a
new data analysis from the BELVIQ® (lorcaserin
HCl) Phase 3 clinical trial program will be presented at the
American Heart Association 2013 Scientific Sessions, November 16-20 in Dallas, Texas.
The following abstract highlighting BELVIQ data will be
presented:
- The Effects of Lorcaserin on High-Sensitivity C-reactive
Protein in Overweight and Obese Patients: Data From Two Phase 3
Trials
Poster number: 2063
This post-hoc analysis of two previously published Phase 3
trials, BLOOM and BLOOM-DM, evaluated the effect of weight loss on
high-sensitivity C-reactive protein (hsCRP) in patients without
diabetes who were obese (body mass index, or BMI, 30-45
kg/m2) or overweight (BMI 27-45 kg/m2) in the
presence of at least one weight-related comorbid condition and
patients with type 2 diabetes who were overweight or obese.
Patients were randomized to placebo or lorcaserin for 52 weeks, and
all patients received diet and exercise counseling. At week 52,
hsCRP levels were assessed for the placebo and lorcaserin groups of
the modified intent-to-treat last observation carried forward
(MITT/LOCF) population of each trial with a baseline hsCRP greater
than 3 mg/L. Results were stratified by 5% or greater weight loss
at week 52 and baseline hsCRP levels greater than 3 mg/L.
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. For
more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
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.
Indications
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).
Limitations of Use:
- 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.
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 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.
About Eisai Inc.
At Eisai Inc., human health care is the goal. Eisai gives
its 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., Eisai's
passionate commitment to patient care is the driving force behind
its efforts to help address unmet medical needs. Eisai is a fully
integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Eisai's 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 www.eisai.com/US.
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 a biopharmaceutical company focused on discovering,
developing and commercializing novel drugs that target G
protein-coupled receptors, or GPCRs, to address unmet medical
needs. 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.
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 and use, safety, efficacy,
mechanism of action, regulatory review and approval, and potential
of BELVIQ or lorcaserin; 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 and supply 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 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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Marcia
Diljak
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alex_scott@eisai.com
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marcia_diljak@eisai.com
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201.746.2177
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201.746.2236
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Contact: Arena
Pharmaceuticals, Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Cindy McGee, Vice
President,
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David Schull,
President
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Investor Relations
& Alliance Management
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david.schull@russopartnersllc.com
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cmcgee@arenapharm.com
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858.717.2310
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858.453.7200, ext.
1479
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.