Arena Pharmaceuticals Announces Eisai's Submission of BELVIQ® (lorcaserin HCl) Marketing Authorization Application in Mexico

Arena Pharmaceuticals Announces Eisai's Submission of BELVIQ® (lorcaserin HCl)
                Marketing Authorization Application in Mexico

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

PR Newswire

SAN DIEGO, April 1, 2013

SAN DIEGO, April 1, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ:
ARNA) announced today that Eisai Laboratorios S. de R.L. de C.V., a subsidiary
of Eisai Inc., has submitted a marketing authorization application (MAA) for
BELVIQ^® (lorcaserin HCl) in Mexico with the Federal Commission for the
Protection Against Sanitary Risk (COFEPRIS). The intended indication for
BELVIQ is as an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with an initial body
mass index (BMI) of 30 kg/m^2 or greater (obese), or 27 kg/m^2 or greater
(overweight) in the presence of at least one weight-related comorbid
condition. Based on the MAA submission, Arena will receive a milestone payment
of $500,000 from Eisai.

"We look forward to the opportunity to help address this unmet medical need by
bringing BELVIQ to patients in Mexico who can benefit from treatment for
chronic weight management," said Jack Lief, Arena's President and Chief
Executive Officer. "We plan to commercialize BELVIQ globally through
collaborations with organizations such as Eisai that are committed to and have
proven capabilities in serving patients and physicians."

Approximately 30 percent of adults in Mexico are obese and 70 percent are
overweight or obese. The rapidly increasing prevalence of overweight and obese
patients is leading to a large health and economic burden in Mexico.

"Eisai is committed to keeping patients' medical needs at the forefront of all
that we do, as part of our human health care corporate mission," said Frank
Ciriello, Senior Vice President, Eisai Inc. "We believe that Eisai has an
opportunity with BELVIQ to bring a new medical option to help address the
needs of patients affected by overweight and obesity in Mexico."

Eisai is responsible for the regulatory approval and, ultimately, marketing
and distribution of BELVIQ in Mexico. Subject to approval, Arena will
manufacture BELVIQ at its facility in Switzerland and sell finished commercial
product to Eisai for distribution in Mexico. 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.

Beyond Mexico, Eisai has marketing and distribution rights in most of North
and South America and also plans to submit MAAs for BELVIQ in Canada and
Brazil this year. In addition, Arena has granted marketing and distribution
rights to Ildong Pharmaceutical Co., Ltd., for South Korea and plans to enter
into additional collaborations to commercialize BELVIQ outside of these
territories. Arena has composition of matter patents for BELVIQ issued in
major jurisdictions globally that, in most cases, are capable of continuing
into 2023, and has filed applications for patent extension in the United
States, which, if granted, will extend the patent term for BELVIQ into 2026.

About BELVIQ^® (lorcaserin HCl)

BELVIQ (pronounced "BEL-VEEK") is believed to decrease food consumption and
promote satiety by selectively activating serotonin 2C receptors in the brain.
Activation of these receptors may help a person eat less and feel full after
eating smaller amounts of food. The exact mechanism of action of BELVIQ is not

BELVIQ currently is not available. BELVIQ is approved by the US Food and Drug
Administration to be used along with 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

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

BELVIQ will be available in the United States only after Drug Enforcement
Agency (DEA) scheduling is effective. The DEA has published a notice in the
Federal Register recommending that BELVIQ be classified as a Schedule IV
controlled substance, and BELVIQ is currently awaiting final scheduling



  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 (eg, 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 (eg, sickle
    cell anemia, multiple myeloma, or leukemia), or in men with anatomical
    deformation of the penis (eg, 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

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 prescribing
information or go to

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, was approved by the US Food and Drug Administration in June
2012, 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

Arena Pharmaceuticals^® and Arena^® are registered service marks of Arena
Pharmaceuticals, Inc. BELVIQ^® is a registered trademark of Arena
Pharmaceuticals GmbH.

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, mechanism of action, and DEA scheduling of BELVIQ;
regulatory filings, review and approval of BELVIQ; commercialization of BELVIQ
outside of the United States and related strategy, including entering into
additional collaborations; the prevalence of overweight and obese patients in
Mexico and related impact; potential of BELVIQ, including in helping patients;
patent coverage; rights, obligations, expectations and future activities
related to the agreement with Eisai; 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 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; 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.

Contact: Arena Pharmaceuticals, Inc.     Media Contact: Russo Partners
Cindy McGee, Vice President              David Schull, President
Investor Relations & Alliance Management                    858.717.2310
858.453.7200, ext. 1479

SOURCE Arena Pharmaceuticals, Inc.

Press spacebar to pause and continue. Press esc to stop.