Last updated on April 19, 2014 at 18:42 EDT

Arena Pharmaceuticals to Present Clinical Data for BELVIQ® (lorcaserin HCl) CIV at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD)

September 18, 2013

SAN DIEGO, Sept. 18, 2013 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that data from the BELVIQ(®) (lorcaserin HCl) Phase 3 clinical trial program will be presented at the following scientific meeting:

49(th) Annual Meeting of the European Association for the Study of Diabetes (EASD)

Barcelona, Spain: September 23-27, 2013

Poster: Lorcaserin HCl Phase 3 Trials in Obese and Overweight Patients: Week-52 Outcomes for Those Achieving at Least 5% Weight Loss at Week 12 (Responders)

Poster session/number: PS 042 Weight Loss and Caloric Modulation, #639

About BELVIQ(®) (lorcaserin HCl) CIV

BELVIQ (pronounced BEL-VEEK) is approved by the US Food and Drug Administration for chronic weight management, and is available by prescription in the United States. BELVIQ( )is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action is not known.

BELVIQ is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index 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).

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.

Arena has granted exclusive marketing and distribution rights to Eisai Inc. for most of North and South America, to Ildong Pharmaceutical Co., Ltd., for South Korea, and to CY Biotech Company Limited for Taiwan. Arena plans to enter into additional collaborations to commercialize BELVIQ outside of these territories.



    --  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
    --  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

Most Common Adverse Reactions

    --  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 (CIV) because it may be abused or lead to drug dependence.

For more information about BELVIQ, click here for the full U.S. Prescribing 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.

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, regulatory review and approval, and potential of BELVIQ; plans to enter into additional collaborations and the commercialization of BELVIQ in additional territories; 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 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 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                    858.717.2310

    858.453.7200, ext. 1479


SOURCE Arena Pharmaceuticals, Inc.

Source: PR Newswire