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Arena Pharmaceuticals Provides Update on Upcoming US Launch of BELVIQ® (lorcaserin HCl) for Chronic Weight Management



    Arena Pharmaceuticals Provides Update on Upcoming US Launch of BELVIQ®
                (lorcaserin HCl) for Chronic Weight Management

-- Arena to Receive $65 Million in Milestone Payments from Eisai --

PR Newswire

SAN DIEGO, May 7, 2013

SAN DIEGO, May 7, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ:
ARNA) announced today that the Office of the Federal Register filed for public
inspection the US Drug Enforcement Administration's (DEA) final rule placing
BELVIQ ^ (pronounced BEL-VEEK) into Schedule IV of the Controlled Substances
Act. The scheduling designation will be effective 30 days after tomorrow's
expected publication in the Federal Register. Following the effective date,
BELVIQ will be available to patients in the United States by prescription, and
Arena will receive $65 million in milestone payments from Eisai Inc. under
their marketing and supply agreement.

BELVIQ is approved for use 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 (e.g., hypertension, dyslipidemia, type 2 diabetes). The
indication includes the following limitations of use: The safety and efficacy
of coadministration of BELVIQ with other products intended for weight loss and
the effect of BELVIQ on cardiovascular morbidity and mortality have not been
established.

"We are thrilled that BELVIQ will soon be available in the United States as a
new treatment option for the medical management of patients who are overweight
with a comorbidity or obese," said Jack Lief, Arena's President and Chief
Executive Officer.

Eisai is responsible for the marketing and distribution of BELVIQ in the
United States. Arena manufactures BELVIQ at its facility in Switzerland, and
sells finished commercial product to Eisai for a purchase price starting at
31.5% of Eisai's annual net product sales. The purchase price increases on a
tiered basis up to 36.5% on the portion of annual net product sales exceeding
$750 million. Arena is also eligible to receive $1.16 billion in purchase
price adjustment payments based on annual net sales levels of BELVIQ.

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.

IMPORTANT SAFETY INFORMATION

Contraindication

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

Warnings and Precautions

  o 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.
  o 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.
  o 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.
  o 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.
  o 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.
  o 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).
  o 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.
  o Consider monitoring for CBC changes, prolactin excess, and pulmonary
    hypertension.

Most Common Adverse Reactions

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

Nursing Mothers

  o BELVIQ should not be taken by women who are nursing.

For more information about BELVIQ, click here for the full 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 registered trademark of Arena
Pharmaceuticals GmbH.

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, mechanism of action, scheduling,
launch and availability of BELVIQ; the potential of BELVIQ, including in
providing a new treatment option; rights, obligations, payments, expectations
and future activities related to the agreement with Eisai; 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
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