WOODCLIFF LAKE, N.J. and
SAN DIEGO, Nov. 3, 2014 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced top-line
results from the Phase 2 trial investigating lorcaserin HCl, a
serotonin 2C receptor agonist, for smoking cessation. The trial
demonstrated statistically significant improvement over placebo in
reducing the number of patients who smoke after 12 weeks of
treatment. The detailed results of the trial are expected to be
presented at a future scientific meeting.
Lorcaserin is an investigational product for smoking cessation.
The efficacy and safety of lorcaserin for smoking cessation have
not been established.
"We are pleased that this proof-of-concept trial provides what
we believe is the first clinical evidence that a selective
serotonin 2C agonist may have a treatment effect for smoking
cessation," said Jack Lief, Arena's President and Chief Executive
Officer. "We will evaluate the full data set to determine next
steps regarding further development of lorcaserin for this
potential indication."
The 12-week, randomized, double-blind, placebo-controlled trial
assessed the efficacy and safety of lorcaserin as a potential aid
to smoking cessation. In the trial, 603 active smokers were
randomized to receive lorcaserin 10 mg once daily (QD), 10 mg twice
daily (BID) or placebo in a 1:1:1 ratio. Patients at baseline were
dependent on nicotine and averaged 18 cigarettes per day. Patients
were dosed for two weeks before attempting to quit around Day 15 of
the trial and received smoking cessation counseling during the
trial.
"Smoking is recognized as one of the greatest global public
health challenges, but unfortunately millions of people around the
world continue to smoke and find it hard to quit," said
Gary Palmer, MD, Eisai's Chief
Medical Officer. "These data advance our knowledge about lorcaserin
and its potential development as an aid to smoking cessation."
The primary objective of the trial was assessment of smoking
cessation efficacy. The carbon monoxide confirmed continuous
abstinence rate (CAR), defined as no reported smoking or other
nicotine use and an end-expiratory exhaled carbon monoxide
measurement of less than or equal to ten parts per million,
measured during the last four weeks of the trial (Weeks 9-12), was
the basis for determining efficacy. The primary endpoint was
achieved by 5.6%, 8.7%, and 15.3% of patients in the placebo, QD
and BID groups, respectively (p-value = 0.003 and odds ratio = 3.02
for BID vs. placebo; the result for QD vs. placebo was not
statistically significant).
Secondary objectives for the trial included assessment of body
weight change and of safety and tolerability. At Week 12 in the
MITT population, there was a statistically significant difference
in weight between lorcaserin BID and placebo (-0.98 kg and -0.01
kg, respectively, p-value = 0.0004).
The overall adverse event profile appears similar to the profile
in previous trials of lorcaserin, with the most common adverse
events being headache, nausea, constipation, dizziness and dry
mouth.
Arena and Eisai share the development costs of the smoking
cessation development program.
About Smoking
According to the US Department of Health and Human Services, the
epidemic of smoking-caused disease in the 20th Century
ranks among the greatest American public health catastrophes. In
the United States, more than 40
million adults smoked in 2012, resulting in smoking attributable
economic costs estimated for the years 2009-2012 to be between
$289 and $332.5 billion. In 2014,
nearly 500,000 American adults are expected to die prematurely
because of smoking. Smoking is also a global issue that results in
more than 5 million deaths worldwide per year.
About Lorcaserin for Smoking Cessation
Internally discovered at Arena, lorcaserin is believed to
selectively activate serotonin 2C receptors in the brain.
Preclinical data suggest that serotonin 2C receptors may modulate
the mesolimbic dopaminergic reward system. The exact mechanism of
action of lorcaserin is not known.
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 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
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 Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's internally discovered drug, BELVIQ®
(lorcaserin HCl), is approved in the
United States, and 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.
About Eisai Inc.
At Eisai Inc., human health care is our 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 has a
passionate commitment to patient care that is the driving force
behind Eisai's efforts to help address unmet medical needs. Eisai
is 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
advancement, therapeutic indication, use, safety, efficacy,
mechanism of action, and potential of BELVIQ or lorcaserin,
including as a potential aid for smoking cessation; significance of
the top-line results from the Phase 2 trial investigating
lorcaserin for smoking cessation, including in advancing knowledge
about lorcaserin and its potential development; future presentation
of the trial results; a selective serotonin 2C agonist's treatment
effect for smoking cessation; evaluation of the full data set and
determining next steps regarding further development of lorcaserin
for smoking cessation; 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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Contact: Arena
Pharmaceuticals,
Inc.
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & Head
of Global Regulatory Affairs
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Russo
Partners
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caudet@arenapharm.com
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david.schull@russopartnersllc.com
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858.453.7200, ext.
1612
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858.717.2310
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SOURCE Arena Pharmaceuticals, Inc.; Eisai Inc.