Arena Pharmaceuticals Announces Filing for Marketing Authorization of BELVIQ® (lorcaserin HCl) in Brazil

Arena Pharmaceuticals Announces Filing for Marketing Authorization of BELVIQ®
                          (lorcaserin HCl) in Brazil

-- Eisai's Filing for Approval of BELVIQ as a Treatment for Chronic Weight
Management Triggers $500,000 Milestone Payment to Arena --

PR Newswire

SAN DIEGO, Feb. 12, 2014

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/m^2), or overweight patients (initial BMI ≥ 27 kg/m^2) 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:

  o30 kg/m^2 or greater (obese), or
  o27 kg/m^2 or greater (overweight) in the presence of at least one
    weight-related comorbid condition (e.g., hypertension, dyslipidemia, type
    2 diabetes).

Limitations of Use:

  oThe 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.
  oThe effect of BELVIQ on cardiovascular morbidity and mortality has not
    been established.

IMPORTANT SAFETY INFORMATION

Contraindication

  oBELVIQ should not be taken during pregnancy or by women who are planning
    to become pregnant.

Warnings and Precautions

  oBELVIQ 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.
  oPatients 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.
  oImpairment 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.
  oThe 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.
  oWeight 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.
  oMen 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).
  oBecause 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.
  oConsider monitoring for CBC changes, prolactin excess, and pulmonary
    hypertension.

Most Common Adverse Reactions in Clinical Trials

  oIn patients without diabetes: headache (17%), dizziness (9%), fatigue
    (7%), nausea (8%), dry mouth (5%), and constipation (6%).
  oIn patients with diabetes: hypoglycemia (29%), headache (15%), back pain
    (12%), cough (8%), and fatigue (7%).

Nursing Mothers

  oBELVIQ 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.     Media Contact: Russo Partners
Cindy McGee, Vice President,             David Schull, President
Investor Relations & Alliance Management david.schull@russopartnersllc.com
cmcgee@arenapharm.com

858.453.7200, ext. 1479                  858.717.2310

www.arenapharm.com







SOURCE Arena Pharmaceuticals, Inc.

Website: http://www.arenapharm.com
 
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