SAN DIEGO and WOODCLIFF LAKE, N.J., Nov. 9, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.
The BLOOM-DM study evaluated 604 obese and overweight patients with type 2 diabetes. Patients were randomized to lorcaserin 10 mg BID (N=256), lorcaserin 10 mg dosed once daily (QD) (N=95) or placebo (N=253). To expedite enrollment, randomization to the lorcaserin 10 mg QD dose was discontinued after approximately 300 patients were enrolled in the trial.
The three primary efficacy endpoints at Week 52 were as follows: the proportion of patients who lose at least 5% of their baseline body weight; change from baseline in body weight; and the proportion of patients who lose at least 10% of their baseline body weight. Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, lorcaserin 10 mg BID met the three primary efficacy endpoints by producing statistically significant weight loss compared to placebo (p<0.0001). At Week 52, 37.5% of patients treated with lorcaserin 10 mg BID achieved at least 5% weight loss, more than double the 16.1% of patients taking placebo. Patients treated with lorcaserin 10 mg BID achieved mean weight loss of 4.5% (4.7 kg), compared to 1.5% (1.6 kg) for placebo. Also, at Week 52, 16.3% of lorcaserin 10 mg BID patients achieved at least 10% weight loss, compared to 4.4% of patients taking placebo.
"We look forward to reviewing the BLOOM-DM data with the FDA as the efficacy results are aligned with the agency's categorical benchmark for weight management," said Jack Lief, Arena's President and Chief Executive Officer.
BLOOM-DM also evaluated multiple secondary endpoints at Week 52. Five families of endpoints have been or are being evaluated: glycemic, lipid, blood pressure, body composition, and Quality of Life (QOL). Data from the first three families are available, and analysis of body composition and QOL are pending. Within the glycemic, lipid and blood pressure families, lorcaserin patients achieved statistically significant improvements relative to placebo in HbA1c and fasting glucose. Lorcaserin 10 mg BID patients achieved a 0.9% reduction in HbA1c, compared to a 0.4% reduction for the placebo group (p<0.0001). At Week 52, changes with lorcaserin treatment relative to placebo for fasting insulin, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and systolic and diastolic blood pressure were not statistically significant.
BLOOM-DM Safety Results
The most frequent adverse events occurring in greater than or equal to 10% of patients (excluding hypoglycemia) and the proportion of patients affected for lorcaserin 10 mg BID and placebo, respectively, were as follows: headache (14.5%, 7.1%), upper respiratory infection (13.7%, 14.7%), back pain (11.7%, 7.9%) and nasopharyngitis (11.3%, 9.9%). Headache and hypoglycemia were the only adverse events that exceeded the placebo rate by greater than 4% of patients. Adverse events of "hypoglycemia," which included asymptomatic low blood glucose measurements and symptomatic events, were reported by 29.3% and 21.0% of lorcaserin 10 mg BID and placebo patients, respectively; however, no events of severe hypoglycemia were reported in either treatment group. Serious adverse events were infrequent. Discontinuations for adverse events were 8.6% for lorcaserin 10 mg BID patients and 4.3% for placebo patients.
Echocardiograms were performed at baseline and at Weeks 24 and 52. At Week 24, 2.5% of lorcaserin 10 mg BID patients and 1.9% of placebo patients had new valvulopathy (based on FDA criteria), and at Week 52, 2.9% of lorcaserin 10 mg BID patients and 0.5% of placebo patients had new valvulopathy. BLOOM-DM was not powered to detect meaningful differences in the incidence of valvulopathy.
Baseline Patient Characteristics
BLOOM-DM evaluated obese and overweight patients with type 2 diabetes treated with one or more oral agents. At baseline, patients had an average Body Mass Index (BMI) of 36, weight of 228 pounds (103.6 kg), age of 53 years, and HbA1c of approximately 8%. Proportions of Caucasian, African American and Hispanic patients were 61%, 21% and 14%, respectively, and 54% of patients were female.
Conference Call & Webcast
Arena will host both a conference call and webcast to discuss top-line results from the BLOOM-DM trial and the third quarter 2010 financial results today, November 9, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "Arena Pharmaceuticals' Third Quarter 2010" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena submitted a New Drug Application for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues.
Phase 3 Program Overview
The lorcaserin Phase 3 program consists of three double-blind, randomized, placebo-controlled trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 patients over a one-year treatment period in obese and overweight patients with type 2 diabetes that is managed with one or more oral anti-hyperglycemic agents. The trials included a standardized program of moderate diet and exercise guidance.
About the FDA Draft Guidance
The FDA draft guidance document "Developing Products for Weight Management" dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States, following FDA approval of the New Drug Application for lorcaserin.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 US pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the US pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes US-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
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, mechanism of action, scheduling and regulatory review, approval and commercialization of lorcaserin; BLOOM-DM, including reviewing its results with the FDA and the alignment of its efficacy results with the FDA's categorical benchmark for weight management; Arena's collaboration with Eisai and activities thereunder; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to 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, top-line results are based on a preliminary analysis of then available data, and such findings and conclusions are subject to change following a more comprehensive review of the data; the risk that regulatory authorities may not find data and other information related to Arena's clinical trials and other studies meet safety or efficacy requirements or are otherwise sufficient for regulatory approval; the timing of regulatory review and approval is uncertain; Arena's response to the complete response letter for the lorcaserin NDA may not be submitted in a timely manner and/or the information provided in such response may not satisfy the FDA; the FDA may request additional information prior to approval; unexpected new data; risks related to commercializing new products; Arena's ability to obtain and defend its 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 Arena or others expect or at all; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from Arena's collaborators; and satisfactory resolution of pending and any future 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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