SAN DIEGO, Feb. 12, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that Eisai
Laboratorios Ltda., a subsidiary of Eisai Inc., has filed for
marketing authorization of BELVIQ® as a treatment for chronic
weight management with the Brazilian Health Surveillance Agency
(Anvisa). In connection with the filing, Arena will receive a
milestone payment of $500,000 from
Eisai.
"With over half of adults in Brazil being overweight or obese, there is a
significant need for new chronic weight management treatments to
help address this medical need," said Jack Lief, Arena's President
and Chief Executive Officer. "The filing of this marketing
application further illustrates Eisai's commitment to make BELVIQ
available to patients and physicians around the world."
BELVIQ is being submitted for marketing authorization in
Brazil as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management in adult obese patients (initial body mass index,
or BMI, ≥ 30 kg/m2), or overweight patients (initial BMI
≥ 27 kg/m2) in the presence of at least one
weight-related comorbid condition (e.g., hypertension,
dyslipidemia, cardiovascular disease, type 2 diabetes managed with
oral hypoglycemic agents, or sleep apnea).
Eisai is responsible for seeking the regulatory approval and the
subsequent marketing and distribution of BELVIQ in Brazil. Arena has granted Eisai marketing and
distribution rights to BELVIQ for all countries worldwide, except
South Korea, Taiwan, Australia, New
Zealand and Israel. Arena
manufactures BELVIQ at its facility in Switzerland, and sells finished commercial
product to Eisai for distribution. Arena is eligible to receive
payments based upon Eisai's net sales of BELVIQ, and is also
eligible to receive regulatory and development milestone
payments.
About BELVIQ® (lorcaserin HCl)
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® (lorcaserin HCl) CIV is Approved for Marketing
in the United States by the US
Food and Drug Administration (FDA)
Indications
BELVIQ is indicated in the United
States as an adjunct to a reduced-calorie diet and increased
physical activity for chronic weight management in adult patients
with an initial BMI of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of
at least one weight-related comorbid condition (e.g., hypertension,
dyslipidemia, type 2 diabetes).
Limitations of Use:
- The safety and efficacy of coadministration of BELVIQ with
other products intended for weight loss, including prescription
drugs (e.g., phentermine), over-the-counter drugs, and herbal
preparations, have not been established.
- The effect of BELVIQ on cardiovascular morbidity and mortality
has not been established.
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 Clinical Trials
- 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 that may lead to
abuse or dependence.
For more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
About Arena Pharmaceuticals
Arena is a biopharmaceutical company focused on discovering,
developing and commercializing novel drugs that target G
protein-coupled receptors, or GPCRs, to address unmet medical
needs. BELVIQ® (lorcaserin HCl), Arena's internally discovered
drug, is approved for marketing in the
United States, and is under review for regulatory approval
in additional territories. 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 trademark of Arena
Pharmaceuticals GmbH, and is registered in the United States and pending in Brazil.
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;
regulatory review and approval, manufacture, sale, and marketing
and distribution of BELVIQ; rights, obligations, payments,
expectations and activities related to the marketing and supply
agreement with Eisai; the prevalence of overweight and obesity in
Brazil, the need for new
treatments and addressing such need; Eisai's commitment to make
BELVIQ available around the world; 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; 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 its collaborator, as applicable, 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.
Contact: Arena Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Cindy McGee, Vice President,
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David Schull,
President
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Investor Relations & Alliance Management
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david.schull@russopartnersllc.com
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cmcgee@arenapharm.com
858.453.7200, ext. 1479
www.arenapharm.com
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858.717.2310
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SOURCE Arena Pharmaceuticals, Inc.