Arena Pharmaceuticals Announces BELVIQ™ (lorcaserin HCl) New Drug Submission in Canada

 Arena Pharmaceuticals Announces BELVIQ™ (lorcaserin HCl) New Drug Submission
                                  in Canada

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

PR Newswire

SAN DIEGO, June 26, 2013

SAN DIEGO, June 26, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ:
ARNA) announced today that Eisai Limited (based in Mississauga, Ontario), a
subsidiary of Eisai Inc., has submitted a New Drug Submission (NDS) for
BELVIQ™ (lorcaserin HCl) with Health Canada. BELVIQ is being evaluated in
Canada as an adjunct to a reduced-calorie diet and increased physical activity
for chronic weight management (including weight loss and weight maintenance)
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
additional cardiovascular risk factor (e.g., hypertension, dyslipidemia, type
2 diabetes, or sleep apnea). In connection with the NDS, Arena will receive a
milestone payment of $500,000 from Eisai.

"Approximately 60 percent of Canadians are overweight or obese, but there are
limited treatment options available in Canada beyond diet and exercise," said
Jack Lief, Arena's President and Chief Executive Officer. "With this New Drug
Submission for BELVIQ, we hope to provide physicians with a new tool to help
motivated patients manage their weight."

Eisai is responsible for the regulatory approval and, ultimately, marketing
and distribution of BELVIQ in Canada. Beyond Canada, Arena has granted Eisai
marketing and distribution rights to BELVIQ in most of North and South
America. 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 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 a 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

  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.

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 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 Canada.

About Eisai Inc.

At Eisai Inc., human health care is the 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's passionate commitment to patient care is the driving force
behind its efforts to help address unmet medical needs. Eisai is a fully
integrated pharmaceutical business with discovery, clinical, manufacturing and
marketing capabilities. Eisai's 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 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 and use,
safety, efficacy, tolerability, selectivity and mechanism of action of BELVIQ;
rights, obligations, milestones, payments, expectations and future activities
related to the marketing and supply agreement with Eisai; the prevalence of
overweight and obesity in Canada and treatment options; the potential of
BELVIQ, including in helping patients; regulatory filings, review and approval
of BELVIQ; 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 and supply issues and the availability of
BELVIQ and pace of market acceptance; cash and revenues generated from BELVIQ,
including the impact of competition; Arena's revenues will be based in part on
management's estimates, judgment and accounting policies, and incorrect
estimates or disagreement regarding Arena's 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 by any other regulatory agency;
regulatory decisions in one territory may impact regulatory decisions in other
territories 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 safety, efficacy or other regulatory requirements or
otherwise be sufficient for 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 programs; 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                    858.717.2310
858.453.7200, ext. 1479

SOURCE Arena Pharmaceuticals, Inc.

Website: http://www.arenapharm.com
Website: http://www.eisai.com
Website: http://www.belviq.com
 
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