Eisai and Arena Pharmaceuticals Announce Publication of Pooled Phase 3 Clinical Trial Analysis of BELVIQ® (lorcaserin HCl) CIV in Postgraduate Medicine

WOODCLIFF LAKE, N.J. and SAN DIEGO, Oct. 10, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical trials of BELVIQ^® (lorcaserin HCl) was published in the October issue of Postgraduate Medicine, a peer-reviewed medical journal for physicians. In the pooled analysis, BELVIQ 10 mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters.

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.

The BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials were conducted in overweight and obese adults without diabetes. The pooled, modified-intent-to-treat results show that a statistically significantly greater number of patients taking BELVIQ lost greater than or equal to 5% and greater than or equal to 10% of body weight compared to placebo (47.1% vs. 22.6% and 22.4% vs. 8.7%, respectively) after one year of treatment. The mean percent weight loss for patients taking BELVIQ was also statistically significantly greater than placebo (-5.8% vs. -2.5%). Mean percent weight loss for those completing one year of treatment was -8.0% for BELVIQ and -3.7% for placebo, respectively. Echocardiograms were conducted on all patients as part of the primary safety endpoint of the trials. There was no apparent increased risk of cardiac valvulopathy associated with use in the combined dataset. The rates of FDA-defined valvulopathy were 2.3% and 2.2% for patients taking BELVIQ or placebo, respectively.

"The publication of this pooled analysis includes part of the dataset reviewed by the FDA in approving BELVIQ as the first new treatment for obesity in over a decade," said Gary Palmer, Chief Medical Officer, Global Neuroscience Business Unit at Eisai Inc. "This analysis provides evidence demonstrating the safety and efficacy profile of BELVIQ, and may be helpful to physicians as they consider pharmacotherapy for patients as part of their overall weight management plan."

Additionally, the data showed that after one year, there were statistically significant improvements in lipid parameters, including total cholesterol, triglyceride levels and HDL cholesterol. Changes in glycemic indicators demonstrated a decrease of 0.11% in HbA1c for BELVIQ treated patients compared to a decrease of 0.05% for placebo treated patients. Mean decreases in both systolic and diastolic blood pressure were also seen and statistically significant for BELVIQ versus placebo.

"We are facing an obesity epidemic in the United States, and it's important for physicians and patients to understand that when behavioral modifications alone are not enough to produce meaningful weight loss, effective pharmacotherapeutic options are available that can be added to a diet and exercise regimen," said William R. Shanahan, M.D., Executive Vice President and Chief Medical Officer of Arena Pharmaceuticals, Inc. "We know that weight loss can improve health parameters for patients who are obese or overweight with a related condition, and this pooled analysis further demonstrates that BELVIQ, in combination with diet and exercise, can be an effective intervention."

The most common adverse events in the pooled analysis included headache, upper respiratory tract infection and nasopharynigtis. Discontinuation rates for adverse events were 8.6% for patients taking BELVIQ and 6.8% for patients taking placebo, and the overall rates for serious adverse events were similar (2.7% and 2.3%, respectively).

About the BLOOM and BLOSSOM Trials

BLOOM and BLOSSOM were Phase 3, randomized, double-blind, placebo-controlled clinical trials designed to evaluate the efficacy and safety of overweight patients without diabetes and included a total of 6,136 patients in the modified-intent-to-treat population. Key inclusion criteria for both studies were age 18 to 65 years (inclusive) and a BMI of 30-45 kg/m², or 27-29.9 kg/m² with at least one coexisting condition (hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance or sleep apnea). Key exclusion criteria included recent cardiovascular events, diabetes mellitus, use of serotonergic antidepressants and high blood pressure. In the two-year BLOOM trial, patients received either BELVIQ 10 mg twice daily in combination with diet and exercise or placebo in combination with diet and exercise for the first year, and those in the BELVIQ group were randomly reassigned to continue BELVIQ or switch to placebo for the second year. In the one-year BLOSSOM trial, patients received either BELVIQ 10 mg once daily in combination with diet and exercise, or placebo. Pooled Phase 3 data indicate that 1,398 patients (43.7%) in the BELVIQ group discontinued from the studies prior to Week 52, as compared to 1,640 (51.4%) in the placebo group. The most common reasons for discontinuation were withdrawal of consent (BELVIQ, 18.8%; placebo, 25.5%) and lost to follow-up (BELVIQ, 12.2%; placebo, 14.4%).

About BELVIQ^® (lorcaserin HCl) CIV

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 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.

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

• Pregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ may harm your unborn baby.
• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
• Valvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems.
• Changes in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you.
• Mental problems: Taking too much BELVIQ may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body.
• Depression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
• Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops.
• Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop taking BELVIQ and call your doctor or go to the nearest emergency room right away.
• Slow heartbeat: BELVIQ may cause your heart to beat slower.
• Decreases in blood cell count: BELVIQ may cause your red and white blood cell counts to decrease.
• Increase in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size.
• Most common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
• Most common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue.
• Nursing: BELVIQ should not be taken while breastfeeding.
• Drug interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC) common cold/cough medicine); OTC supplements such as tryptophan or St. John's Wort; or erectile dysfunction medicines.

BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.

BELVIQ is approved by the U.S. 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.

For more information about BELVIQ, click here for the full U.S. FDA-approved Product Information or visit www.BELVIQ.com.

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 U.S. 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.

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, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin; the significance and helpfulness of the pooled analysis and its results; pharmacotherapy being considered as part of an overall weight management plan; the importance of understanding when behavioral modifications alone are not enough and the addition of pharmacotherapeutic options; improving health parameters with weight loss; effectiveness of BELVIQ in combination with diet and exercise; 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 Arena's 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, 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.

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SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.

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