WOODCLIFF LAKE, N.J. and
SAN DIEGO, Oct. 10, 2014 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that a
pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical
trials of BELVIQ® (lorcaserin HCl) was published in the
October issue of Postgraduate Medicine, a peer-reviewed
medical journal for physicians. In the pooled analysis, BELVIQ 10
mg twice daily, as compared to placebo and both in conjunction with
diet and exercise, was associated with statistically significant
weight loss and clinically relevant improvements in cardiometabolic
parameters.
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.
The BLOOM (Behavioral modification and Lorcaserin
for Overweight and Obesity Management) and
BLOSSOM (Behavioral modification and LOrcaserin
Second Study for Obesity Management)
trials were conducted in overweight and obese adults without
diabetes. The pooled, modified-intent-to-treat results show that a
statistically significantly greater number of patients taking
BELVIQ lost greater than or equal to 5% and greater than or equal
to 10% of body weight compared to placebo (47.1% vs. 22.6% and
22.4% vs. 8.7%, respectively) after one year of treatment. The mean
percent weight loss for patients taking BELVIQ was also
statistically significantly greater than placebo (-5.8% vs. -2.5%).
Mean percent weight loss for those completing one year of treatment
was -8.0% for BELVIQ and -3.7% for placebo, respectively.
Echocardiograms were conducted on all patients as part of the
primary safety endpoint of the trials. There was no apparent
increased risk of cardiac valvulopathy associated with use in the
combined dataset. The rates of FDA-defined valvulopathy were 2.3%
and 2.2% for patients taking BELVIQ or placebo, respectively.
"The publication of this pooled analysis includes part of the
dataset reviewed by the FDA in approving BELVIQ as the first new
treatment for obesity in over a decade," said Gary Palmer, Chief Medical Officer, Global
Neuroscience Business Unit at Eisai Inc. "This analysis provides
evidence demonstrating the safety and efficacy profile of BELVIQ,
and may be helpful to physicians as they consider pharmacotherapy
for patients as part of their overall weight management plan."
Additionally, the data showed that after one year, there were
statistically significant improvements in lipid parameters,
including total cholesterol, triglyceride levels and HDL
cholesterol. Changes in glycemic indicators demonstrated a decrease
of 0.11% in HbA1c for BELVIQ treated patients compared to a
decrease of 0.05% for placebo treated patients. Mean decreases in
both systolic and diastolic blood pressure were also seen and
statistically significant for BELVIQ versus placebo.
"We are facing an obesity epidemic in the United States, and it's important for
physicians and patients to understand that when behavioral
modifications alone are not enough to produce meaningful weight
loss, effective pharmacotherapeutic options are available that can
be added to a diet and exercise regimen," said William R. Shanahan, M.D., Executive Vice
President and Chief Medical Officer of Arena Pharmaceuticals, Inc.
"We know that weight loss can improve health parameters for
patients who are obese or overweight with a related condition, and
this pooled analysis further demonstrates that BELVIQ, in
combination with diet and exercise, can be an effective
intervention."
The most common adverse events in the pooled analysis included
headache, upper respiratory tract infection and nasopharynigtis.
Discontinuation rates for adverse events were 8.6% for patients
taking BELVIQ and 6.8% for patients taking placebo, and the overall
rates for serious adverse events were similar (2.7% and 2.3%,
respectively).
About the BLOOM and BLOSSOM Trials
BLOOM and BLOSSOM were Phase 3, randomized, double-blind,
placebo-controlled clinical trials designed to evaluate the
efficacy and safety of overweight patients without diabetes and
included a total of 6,136 patients in the modified-intent-to-treat
population. Key inclusion criteria for both studies were age 18 to
65 years (inclusive) and a BMI of 30-45 kg/m2, or
27-29.9 kg/m2 with at least one coexisting condition
(hypertension, dyslipidemia, cardiovascular disease, impaired
glucose tolerance or sleep apnea). Key exclusion criteria included
recent cardiovascular events, diabetes mellitus, use of
serotonergic antidepressants and high blood pressure. In the
two-year BLOOM trial, patients received either BELVIQ 10 mg twice
daily in combination with diet and exercise or placebo in
combination with diet and exercise for the first year, and those in
the BELVIQ group were randomly reassigned to continue BELVIQ or
switch to placebo for the second year. In the one-year BLOSSOM
trial, patients received either BELVIQ 10 mg once daily in
combination with diet and exercise, or placebo. Pooled Phase 3 data
indicate that 1,398 patients (43.7%) in the BELVIQ group
discontinued from the studies prior to Week 52, as compared to
1,640 (51.4%) in the placebo group. The most common reasons for
discontinuation were withdrawal of consent (BELVIQ, 18.8%; placebo,
25.5%) and lost to follow-up (BELVIQ, 12.2%; placebo, 14.4%).
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 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 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.
Important Safety Information
- Pregnancy: Do not take BELVIQ if you
are pregnant or planning to become pregnant, as weight loss offers
no potential benefit during pregnancy and BELVIQ may harm your
unborn baby.
- Serotonin Syndrome or Neuroleptic
Malignant Syndrome (NMS)-like reactions: Before using BELVIQ,
tell your doctor about all the medicines you take, especially
medicines that treat depression, migraines, mental problems, or the
common cold. These medicines may cause serious or life-threatening
side effects if taken with BELVIQ. Call your doctor right away if
you experience agitation, hallucinations, confusion, or other
changes in mental status; coordination problems; uncontrolled
muscle spasms; muscle twitching; restlessness; racing or fast
heartbeat; high or low blood pressure; sweating; fever; nausea;
vomiting; diarrhea; or stiff muscles.
- Valvular heart disease: Some people
taking medicines like BELVIQ have had heart valve problems. Call
your doctor right away if you experience trouble breathing;
swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or
weakness that will not go away; or fast or irregular heartbeat.
Before taking BELVIQ, tell your doctor if you have or have had
heart problems.
- Changes in attention or memory: BELVIQ
may slow your thinking. You should not drive a car or operate heavy
equipment until you know how BELVIQ affects you.
- Mental problems: Taking too much
BELVIQ may cause hallucinations, a feeling of being high or in a
very good mood, or feelings of standing outside your body.
- Depression or thoughts of suicide:
Call your doctor right away if you notice any mental changes,
especially sudden changes in your mood, behaviors, thoughts, or
feelings, or if you have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause
low blood sugar in people taking medicines for type 2 diabetes,
such as insulin or sulfonylureas. Blood sugar levels should be
checked before and while taking BELVIQ. Changes to diabetes
medication may be needed if low blood sugar develops.
- Painful erections: If you have an
erection lasting more than 4 hours while on BELVIQ, stop taking
BELVIQ and call your doctor or go to the nearest emergency room
right away.
- Slow heartbeat: BELVIQ may cause your
heart to beat slower.
- Decreases in blood cell count: BELVIQ
may cause your red and white blood cell counts to decrease.
- Increase in prolactin: BELVIQ may
increase the amount of a hormone called prolactin. Tell your doctor
if your breasts begin to make milk or a milky fluid, or if you are
a male and your breasts increase in size.
- Most common side effects in patients
without diabetes: Headache, dizziness, fatigue, nausea, dry
mouth, and constipation.
- Most common side effects in patients with
diabetes: Low blood sugar, headache, back pain, cough, and
fatigue.
- Nursing: BELVIQ should not be taken
while breastfeeding.
- Drug interactions: Before taking
BELVIQ, tell your doctor if you take medicines for depression,
migraines, or other medical conditions, such as: triptans;
medicines used to treat mood, anxiety, psychotic or thought
disorders, including tricyclics, lithium, selective serotonin
reuptake inhibitors, selective serotonin-norepinephrine reuptake
inhibitors, monoamine oxidase inhibitors, or antipsychotics;
cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan
(an over-the-counter (OTC) common cold/cough medicine); OTC
supplements such as tryptophan or St. John's Wort; or erectile
dysfunction medicines.
BELVIQ is a federally controlled substance (CIV) because it may
be abused or lead to drug dependence.
BELVIQ is approved by the U.S. 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 U.S.
FDA-approved Product Information or visit www.BELVIQ.com.
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.
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; the
significance and helpfulness of the pooled analysis and its
results; pharmacotherapy being considered as part of an overall
weight management plan; the importance of understanding when
behavioral modifications alone are not enough and the addition of
pharmacotherapeutic options; improving health parameters with
weight loss; effectiveness of BELVIQ in combination with diet and
exercise; 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 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.
|
|
|
|
Investor
Inquiries:
|
Media
Inquiries:
|
Alex Scott
|
Laurie
Landau
|
alex_scott@eisai.com
|
laurie_landau@eisai.com
|
201.746.2177
|
201.746.2510
|
|
|
Contact: Arena
Pharmaceuticals, Inc.
|
|
|
|
Investor
Inquiries:
|
Media
Inquiries:
|
Craig M. Audet,
Ph.D.,
|
David Schull,
President
|
Senior Vice
President,
|
david.schull@russopartnersllc.com
|
Operations & Head
of Global
|
858.717.2310
|
Regulatory
Affairs
|
|
caudet@arenapharm.com
|
|
858.453.7200 ext.
1612
|
|
Logo -
http://photos.prnewswire.com/prnh/20120413/MM87168LOGO
SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.