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

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/m² or greater (obese), or 27 kg/m² 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 known.

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:

• 30 kg/m² or greater (obese), or
• 27 kg/m² 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

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 designation. 

IMPORTANT SAFETY INFORMATION

Contraindication

• 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 (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.
• 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.
• 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 (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).
• 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 hypertension.

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.

For more information about BELVIQ, click here for the full prescribing information or go to http://us.eisai.com/package_inserts/BelviqPI.pdf.

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 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, 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.

SOURCE Arena Pharmaceuticals, Inc.