Key Developments For Arena Pharmaceuticals Inc
Arena Pharmaceuticals Inc (ARNA.O) (Consolidated Issue listed on NASDAQ Global Market)
Arena Pharmaceuticals Reiterates FY 2009 Revenue Outlook-Conference Call
Arena Pharmaceuticals announced that for fiscal 2009, it continues to expect revenues to be in the range of $9 to $11 million.
New Data From Arena Pharmaceuticals' Pivotal BLOSSOM Trial Of Lorcaserin Demonstrate Improvements In Patients' Body Composition, Cardiovascular Risk Factors And Quality Of Life
Arena Pharmaceuticals announced the data from the pivotal BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) Phase 3 trial that demonstrate improvements in patients' body composition, cardiovascular risk factors and quality of life. These findings add to the previously announced top-line BLOSSOM data that showed highly significant weight loss with lorcaserin over one year of treatment in 4,008 patients. Using Intent-to-Treat Last Observation Carried Forward (ITT-LOCF) analysis, lorcaserin patients achieved highly significant improvements in Body Mass Index (BMI), waist circumference and hip circumference. Changes from baseline for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: BMI (kg/m squared), (-2.1, -1.7, -1.0); waist circumference (cm), (-6.2, -5.6, -4.2); and hip circumference (cm), (-5.3, -5.0, -3.3), (p<0.0001) compared to placebo for all measurements. In addition, lorcaserin patients lost significantly more body fat than the placebo patients. Lorcaserin did not increase depression or suicidal ideation compared to placebo. Adverse events related to depression and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: depression (1.9%, 1.1%, 1.8%); depressed mood (0.6%, 0.9%, 0.9%); and depressive symptoms (<0.1%, 0%, 0%).
Arena Pharmaceuticals Announces Positive Data From Pivotal BLOOM Phase Three Trial
Arena Pharmaceuticals announced that data from the pivotal BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) Phase 3 trial demonstrate lorcaserin significantly increased excess weight loss, improved markers of cardiovascular risk and glycemic parameters, and was not associated with depression or suicidal ideation. Additional subgroup analyses showed that lorcaserin caused the greatest improvements in lipid profiles, glycemic parameters and other markers of cardiovascular risk in patients in the highest risk categories. In addition the presentation reported that lorcaserin demonstrated no increase in depression or suicidal ideation compared to placebo. Depression and suicidal ideation were monitored prospectively using the Beck Depression Inventory-II (BDI-II) and by adverse event reporting. At Week 52, 18.0% of lorcaserin patients and 16.1% of placebo patients reported at least a five-point improvement from baseline in BDI-II. A smaller number of lorcaserin patients had increases in the BDI-II total score as compared to placebo. Adverse events related to depression and their total rates at Year 1 for patients who took lorcaserin or placebo, respectively, were 3.1% and 3.0%. In addition, cumulative incidence of suicidal ideation was prospectively evaluated by administration of the BDI-II Questionnaire and did not differ between the lorcaserin and placebo groups at each measurement through two years of treatment.
Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results
Arena Pharmaceuticals reported positive, highly significant top line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial. BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients evaluated for up to two years. Arena plans to submit a New Drug Application, or NDA, for lorcaserin to the US Food and Drug Administration, or FDA, in December. In the one year BLOSSOM trial, lorcaserin met all primary efficacy and safety endpoints. Patients achieved highly significant categorical and absolute weight loss. Lorcaserin was very well tolerated and was not associated with depression or suicidal ideation. The integrated echocardiographic data set from BLOSSOM and BLOOM rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Treatment with lorcaserin also resulted in significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk.
Arena Pharmaceuticals Reaffirms FY 2009 Revenue Guidance-Conference Call
Arena Pharmaceuticals reaffirmed fiscal 2009 guidance for revenue to be in the range of $9 to $11 million.
