WOODCLIFF LAKE, N.J. and SAN DIEGO, Oct. 31, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that data for BELVIQ® (lorcaserin HCl) CIV will be presented during ObesityWeekSM hosted by The Obesity Society and the American Society for Metabolic and Bariatric Surgery. The meeting is taking place November 2-7, 2014, in Boston, Massachusetts. There will be one oral presentation and seven poster presentations.
"Obesity is a complex and chronic disease that is often associated with multiple comorbid conditions," said Elisa Fabbrini, MD, PhD, Assistant Professor in Medicine, Washington University School of Medicine in St. Louis. "The lorcaserin data analyses scheduled for presentation demonstrate the need for ongoing research in the area of weight management programs."
BELVIQ is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
"These data presentations taking place during ObesityWeek support Eisai's commitment to advancing the understanding of obesity, a chronic, progressive disease that has serious consequences, and the role of lorcaserin in this patient population," said Gary Palmer, MD, Chief Medical Officer at Eisai Inc.
- Early Effects of Lorcaserin on Fasting Plasma Glucose and Fasting Insulin in Patients With Overweight and Obesity and With Type 2 Diabetes Mellitus
Abstract number: T-3028-OR
This retrospective analysis of the BLOOM-DM study evaluated the glycemic effects of lorcaserin on obese and overweight patients with type 2 diabetes at multiple time points over 52 weeks of treatment.
- Combination Weight Management Pharmacotherapy With Lorcaserin and Immediate Release Phentermine
Abstract number: TLB-2053-P
This pilot study assessed safety as the primary endpoint, and the effect on weight management as a secondary endpoint, of lorcaserin when administered with phentermine for 12 weeks.
- Shifts from Obese to Non-Obese BMI Categories in Patients Treated With Lorcaserin: A Retrospective Analysis of Three Phase 3 Studies in Patients With Overweight and Obesity
Abstract number: T-2594-P
This post-hoc analysis for BLOSSOM, BLOOM and BLOOM-DM evaluated the effect of lorcaserin on BMI shifts in obese patients with or without type 2 diabetes.
- Characterization of Hypoglycemia in Patients With Type 2 Diabetes With Lorcaserin Therapy During the BLOOM-DM Phase 3 Study
Abstract number: T-2580-P
This post-hoc analysis examined hypoglycemic events in obese and overweight patients with type 2 diabetes on lorcaserin or placebo during the BLOOM-DM study.
- Determination of Number Needed to Treat With Lorcaserin to Achieve HbA1c Reductions of >/-0.5% in Patients With Overweight and Obesity, and With Type 2 Diabetes: A Retrospective Analysis of the BLOOM-DM Study
Abstract number: T-2576-P
This post-hoc analysis of the BLOOM-DM study evaluated the number needed to treat with lorcaserin to achieve HbA1c reductions of >/-0.5% at 52 weeks in obese and overweight patients with type 2 diabetes.
- The Effects of Lorcaserin on Weight Loss in Postmenopausal Women With Overweight and Obesity and With and Without Type 2 Diabetes Mellitus
Abstract number: T-2619-P
This post-hoc analysis of the BLOSSOM and BLOOM-DM studies evaluated weight loss and glycemic parameters by menopausal status in obese and overweight women with or without type 2 diabetes treated with lorcaserin or placebo.
- Effects of Lorcaserin on Weight Loss in Patients With Severe Obesity
Abstract number: T-2656-P
This post-hoc analysis of patients with severe obesity from the BLOSSOM, BLOOM and BLOOM-DM studies evaluated the efficacy and safety of lorcaserin versus placebo for weight loss over 52 weeks.
- Patient Survey on Weight Loss Medication Use in the US
Abstract number: T-2775-P
This analysis explored current utilization and patient perception of weight loss medications in Americans that are overweight or obese.
About BELVIQ® (lorcaserin HCl) CIV
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 is approved by the US Food and Drug Administration. Eisai markets and distributes BELVIQ in the United States, and Arena manufactures and supplies the finished commercial product from its facility in Switzerland. Eisai and Arena's marketing and supply agreement for BELVIQ covers most territories worldwide.
IMPORTANT SAFETY INFORMATION
- 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 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 (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 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%).
- 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.
Eisai is responsible for the marketing and distribution of BELVIQ in most territories worldwide under its agreement with Arena. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our 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., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our 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 us at 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.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. 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.
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, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin, including with respect to coadministration with phentermine; future presentations; significance of post-hoc analyses, their results and presentations; potential of pharmacotherapies; need for ongoing research; commitment to advancing the understanding of obesity and the role of lorcaserin; rights, obligations and activities under the marketing and supply agreement among Arena and Eisai; embracing the challenge of improving health; seeking to bring innovative medicines to patients; 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: top-line results are not comprehensive and are based on a preliminary analysis of then available data, and findings and conclusions related to the trial are subject to change following a more comprehensive review of the data; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing 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 (or Arena or a collaborator may not pursue) 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.
Contacts: Eisai Inc.
Contacts: Arena Pharmaceuticals, Inc.
Craig M. Audet, Ph.D.,
David Schull, President
Senior Vice President,
Operations & Head of Global
858.453.7200, ext. 1612
SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.