WOODCLIFF LAKE, N.J. and
SAN DIEGO, Oct. 31, 2014
/PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc.
(NASDAQ: ARNA) announced today that data for BELVIQ®
(lorcaserin HCl) CIV will be presented during
ObesityWeekSM hosted by The Obesity Society and the
American Society for Metabolic and Bariatric Surgery. The meeting
is taking place November 2-7, 2014,
in Boston, Massachusetts. There
will be one oral presentation and seven poster presentations.
"Obesity is a complex and chronic disease that is often
associated with multiple comorbid conditions," said Elisa Fabbrini, MD, PhD, Assistant Professor in
Medicine, Washington University School
of Medicine in St. Louis. "The
lorcaserin data analyses scheduled for presentation demonstrate the
need for ongoing research in the area of weight management
programs."
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. It is not known if BELVIQ is safe and effective when
taken with other prescription, over-the-counter, or herbal weight
loss products, nor is it known if BELVIQ changes the risk of heart
problems or stroke, or death due to heart problems or stroke.
"These data presentations taking place during ObesityWeek
support Eisai's commitment to advancing the understanding of
obesity, a chronic, progressive disease that has serious
consequences, and the role of lorcaserin in this patient
population," said Gary Palmer, MD,
Chief Medical Officer at Eisai Inc.
Oral Presentation:
- Early Effects of Lorcaserin on Fasting Plasma Glucose and
Fasting Insulin in Patients With Overweight and Obesity and With
Type 2 Diabetes Mellitus
Abstract number: T-3028-OR
This retrospective analysis of the BLOOM-DM study evaluated the
glycemic effects of lorcaserin on obese and overweight patients
with type 2 diabetes at multiple time points over 52 weeks of
treatment.
Poster Presentations:
- Combination Weight Management Pharmacotherapy With Lorcaserin
and Immediate Release Phentermine
Abstract number: TLB-2053-P
This pilot study assessed safety as the primary endpoint, and the
effect on weight management as a secondary endpoint, of lorcaserin
when administered with phentermine for 12 weeks.
- Shifts from Obese to Non-Obese BMI Categories in Patients
Treated With Lorcaserin: A Retrospective Analysis of Three Phase 3
Studies in Patients With Overweight and Obesity
Abstract number: T-2594-P
This post-hoc analysis for BLOSSOM, BLOOM and BLOOM-DM evaluated
the effect of lorcaserin on BMI shifts in obese patients with or
without type 2 diabetes.
- Characterization of Hypoglycemia in Patients With Type 2
Diabetes With Lorcaserin Therapy During the BLOOM-DM Phase 3
Study
Abstract number: T-2580-P
This post-hoc analysis examined hypoglycemic events in obese and
overweight patients with type 2 diabetes on lorcaserin or placebo
during the BLOOM-DM study.
- Determination of Number Needed to Treat With Lorcaserin to
Achieve HbA1c Reductions of >/-0.5% in Patients With Overweight
and Obesity, and With Type 2 Diabetes: A Retrospective Analysis of
the BLOOM-DM Study
Abstract number: T-2576-P
This post-hoc analysis of the BLOOM-DM study evaluated the number
needed to treat with lorcaserin to achieve HbA1c reductions of
>/-0.5% at 52 weeks in obese and overweight patients with type 2
diabetes.
- The Effects of Lorcaserin on Weight Loss in Postmenopausal
Women With Overweight and Obesity and With and Without Type 2
Diabetes Mellitus
Abstract number: T-2619-P
This post-hoc analysis of the BLOSSOM and BLOOM-DM studies
evaluated weight loss and glycemic parameters by menopausal status
in obese and overweight women with or without type 2 diabetes
treated with lorcaserin or placebo.
- Effects of Lorcaserin on Weight Loss in Patients With Severe
Obesity
Abstract number: T-2656-P
This post-hoc analysis of patients with severe obesity from the
BLOSSOM, BLOOM and BLOOM-DM studies evaluated the efficacy and
safety of lorcaserin versus placebo for weight loss over 52
weeks.
- Patient Survey on Weight Loss Medication Use in the
US
Abstract number: T-2775-P
This analysis explored current utilization and patient perception
of weight loss medications in Americans that are overweight or
obese.
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
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 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 drug dependence.
For more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
Eisai is responsible for the marketing and distribution of
BELVIQ in most territories worldwide under its agreement with
Arena. BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
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 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 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 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, and potential of BELVIQ or lorcaserin,
including with respect to coadministration with phentermine; future
presentations; significance of post-hoc analyses, their results and
presentations; potential of pharmacotherapies; need for ongoing
research; commitment to advancing the understanding of obesity and
the role of lorcaserin; rights, obligations and activities 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
actual results to differ materially from the forward-looking
statements include, but are not limited to, the following: top-line
results are not comprehensive and are based on a preliminary
analysis of then available data, and findings and conclusions
related to the trial are subject to change following a more
comprehensive review of the data; 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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Contacts: Arena
Pharmaceuticals, Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Craig M. Audet,
Ph.D.,
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David Schull,
President
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Senior Vice
President,
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Russo
Partners
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Operations & Head
of Global
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david.schull@russopartnersllc.com
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Regulatory
Affairs
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858.717.2310
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caudet@arenapharm.com
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858.453.7200, ext.
1612
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.