WOODCLIFF LAKE, N.J., and
SAN DIEGO, Nov. 2, 2015 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that six
posters regarding lorcaserin HCl data 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 2-6, 2015,
in Los Angeles, California.
The following data will be presented during "Poster Session 1"
on Wednesday, November 4, 2015, from
11:45 a.m. – 1:30 p.m. (Pacific Time):
- Urinary Catecholamines as a Marker of Lorcaserin Action on
Vital Signs
Poster Number: T-P-3156
This post-hoc analysis of the TULIP study evaluated urinary
catecholamines in patients treated with lorcaserin to assess the
impact of lorcaserin on sympathetic nervous system activity
(SNSA).
- Network Meta-Analysis of Treatments for Patients with Type 2
Diabetes Mellitus and Obesity
Poster Number: T-P-3151
This network meta-analysis, consisting of a systematic review of
randomized clinical trials, compared the impact of adding
lorcaserin versus a second non-insulin, anti-diabetic medication to
metformin on weight and glycemic control.
- Cost Implication of Using Lorcaserin in Weight Management
Prior to Bariatric Surgery
Poster Number: T-P-3139
This economic model, conducted in a hypothetical US health plan of
one million members over a 2-year horizon, evaluated the cost
implication of lorcaserin in weight management prior to bariatric
surgery from the payers' perspective.
- The Impact of Weight Loss Therapy on Food Cravings: An
Exploratory Analysis From a 12-Week Pilot Safety Study With
Lorcaserin and Phentermine
Poster Number: T-P-3154
This analysis of adults with overweight or obesity evaluated the
impact of weight loss with lorcaserin alone or in combination with
two doses of immediate-release phentermine on general and specific
cravings from the Food Craving Inventory (FCI).
- The Impact of Weight Loss Therapy on Control of Eating: An
Exploratory Analysis From a 12-Week Pilot Safety Study
Poster Number: T-P-3153
This analysis of adults with overweight or obesity used the Control
of Eating Questionnaire (COEQ) to evaluate the impact of lorcaserin
alone or lorcaserin with two doses of immediate-release phentermine
on patients' ability to manage hunger and cravings during weight
loss treatment.
- Assessment of Liver Function in Patients Treated With
Lorcaserin (LOR) Alone and in Combination With Immediate-Release
Phentermine (PHEN)
Poster Number: T-P-3135
This post-hoc analysis evaluated liver function parameters in a
pilot safety study of patients treated with lorcaserin alone or in
combination with two doses of immediate-release phentermine.
Lorcaserin includes the following limitations of use: the safety
and efficacy of coadministration of lorcaserin with other products
for weight loss and the effect of lorcaserin on cardiovascular
morbidity and mortality have not been established.
About BELVIQ® (lorcaserin HCl) CIV for Chronic
Weight Management
Lorcaserin is marketed in the United
States under the brand name BELVIQ. BELVIQ is a serotonin 2C
receptor agonist approved 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.
BELVIQ is also approved for weight management in South Korea.
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 dependence.
About Arena Pharmaceuticals
Arena embraces the challenge of improving health by seeking to
bring innovative medicines targeting G protein-coupled receptors to
patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. Arena has US operations
located in San Diego, California,
and operations outside of the United
States, including its commercial manufacturing facility,
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.
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 U.S.
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.
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 marketing,
therapeutic indication, use, safety, efficacy, mechanism of action
and potential of BELVIQ or lorcaserin; presentation of data;
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 or lorcaserin; cash and revenues generated from
BELVIQ, including the impact of competition; the risk that Arena's
revenues are 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 lorcaserin may not be approved
for marketing 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 and third parties' intellectual
property rights; the timing, success and cost of Arena's research
and development and related strategy and decisions; 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,
Operations & Head
of Global Regulatory Affairs
caudet@arenapharm.com
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 Arena Pharmaceuticals, Inc.; Eisai Inc.