WOODCLIFF LAKE, N.J. and
SAN DIEGO, Dec. 1, 2015 /PRNewswire/ -- Eisai Inc. and Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the
CAMELLIA-TIMI 61 study has reached its target enrollment of 12,000
patients at more than 470 sites in eight countries. The
CAMELLIA-TIMI 61 outcomes study is designed to evaluate the impact
of long-term treatment with BELVIQ®
(lorcaserin HCl) CIV on the incidence of major adverse
cardiovascular events and conversion to type 2 diabetes mellitus in
obese and overweight patients with cardiovascular disease and/or
multiple cardiovascular risk factors.
"We are pleased to see full enrollment in this important study,
which will advance scientific understanding of the long-term safety
and efficacy of BELVIQ in overweight and obese patients," said
Andrew Satlin, MD, Executive Vice
President, Neuroscience and General Medicine PCU, Eisai Inc. "As a
company focused on human health care, we are committed to
increasing our knowledge of the effects of BELVIQ on cardiovascular
health."
The five-year study, conducted in partnership with the
Thrombolysis in Myocardial Infarction (TIMI) Study Group, will
address the post-marketing requirement from the U.S. Food and Drug
Administration to evaluate the long-term cardiovascular safety of
BELVIQ. In addition, the study includes two primary efficacy
endpoints: (1) to assess the effect of BELVIQ on cardiovascular
event risk reduction and (2) to assess the effect of BELVIQ on the
conversion to type 2 diabetes mellitus among patients without
diabetes at baseline.
"We are very excited that CAMELLIA-TIMI 61 has completed
enrollment in such a timely fashion," said Benjamin M. Scirica, MD, MPH, Senior
Investigator, TIMI Study Group and Associate Professor of Medicine,
Harvard Medical School and Co-Primary
Investigator of the CAMELLIA-TIMI 61 Trial. "The enthusiasm and
speed of enrollment highlights the commitment to evaluate the
efficacy and safety of pharmacotherapy in obese and overweight
patients who have cardiovascular disease or are at risk of
cardiovascular complications. As the largest ongoing outcomes trial
in obesity, CAMELLIA-TIMI 61 will provide invaluable information
about this traditionally difficult to treat population."
BELVIQ is used along with 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 believed to promote
satiety and decrease food consumption by selectively activating
serotonin 2C receptors in the brain. The exact mechanism of action
of BELVIQ is not known.
"We commend Eisai on the progress they have made in advancing
CAMELLIA and on reaching this significant milestone," said
Harry F. Hixson, Jr., Arena's
interim Chief Executive Officer. "Data from this cardiovascular
outcomes trial will provide a better understanding of the potential
of long-term treatment with BELVIQ, and we look forward to the
study results."
About the Study
The CAMELLIA (Cardiovascular And
Metabolic Effects of Lorcaserin In
Overweight And Obese Patients) TIMI 61 study is the
largest ongoing double-blind, placebo-controlled, parallel-group
Phase IIIB/IV study among weight loss medications. The primary
safety objective is to evaluate the incidence of major adverse
cardiovascular events (MACE), defined as cardiovascular death,
myocardial infarction or stroke. If the primary safety objective is
met, the co-primary efficacy objectives are to evaluate the impact
of BELVIQ on the incidence of: (1) MACE+, defined as MACE or
hospitalization due to unstable angina or heart failure, or any
coronary revascularization, and (2) conversion to type 2 diabetes
mellitus for subjects without diabetes at baseline. In addition,
the study will evaluate the efficacy of BELVIQ with respect to
glycemic control in patients with type 2 diabetes mellitus.
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.
For more information about BELVIQ, click here for the full
Product Information or visit www.BELVIQ.com.
About Obesity
Obesity is a serious and growing public health issue. The
prevalence of obesity in the U.S. has more than doubled among
adults in the past 30 years. Approximately 69 percent of American
adults over the age of 20 are affected by obesity and overweight.
This dramatic rise in obesity has also had a major impact on other
diseases.
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 and Pennsylvania, as well as a global demand chain
organization that includes 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. 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 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 the TIMI Study Group
The TIMI Study Group is an Academic Research Organization based
at Brigham and Women's Hospital that has been leading
practice-changing cardiovascular clinical trials for 30 years.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching
affiliate of Harvard Medical School and
a founding member of Partners HealthCare. BWH has more than 3.5
million annual patient visits, is the largest birthing center in
New England and employs nearly 15,000 people.
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 cardiovascular outcomes
study of BELVIQ, including the protocol, design, scope, enrollment,
importance, significance, advancing understanding related to
BELVIQ, providing invaluable information, addressing post-marketing
requirements and other expectations; 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: the cardiovascular outcomes
study of BELVIQ may not proceed at all or in the manner or time
expected, and the results of the study may not satisfy
post-marketing requirements or otherwise be as expected; 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; 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 receive any additional marketing
approvals; 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,
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Operations & Head
of Global Regulatory Affairs
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caudet@arenapharm.com
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858.453.7200, ext.
1612
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visit:http://www.prnewswire.com/news-releases/eisai-and-arena-pharmaceuticals-announce-completion-of-enrollment-in-belviq-lorcaserin-hci-camellia-timi-61-study-300185958.html
SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.