Arena Pharmaceuticals Inc. Reports Operating Results (10-K)
Arena Pharmaceuticals Inc. has a market cap of $180.9 million; its shares were traded at around $1.49 with and P/S ratio of 17.4. Arena Pharmaceuticals Inc. had an annual average earning growth of 21% over the past 10 years.
Highlight of Business Operations: Our most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss. According to the Centers for Disease Control and Prevention, approximately one-third of US adults were obese in 2007-2008. Studies have shown that a weight loss of 5% to 10% of body weight from baseline can result in meaningful improvements in cardiovascular risk factors (e.g., lipids, blood pressure and blood glucose) and a significant reduction in the incidence of type 2 diabetes. There are currently limited pharmaceutical treatment options to help patients lose weight.
The three hierarchically ordered primary efficacy endpoints in each Phase 3 clinical trial were the proportion of patients achieving 5% or greater weight loss from baseline at Week 52, mean weight change from baseline at Week 52 and the proportion of patients achieving 10% or greater weight loss from baseline at Week 52. Secondary endpoints included changes in physical measures, serum lipids, blood pressure, HbA1c levels and other indicators of glycemic control, body compositions (in BLOSSOM and BLOOM-DM), high-sensitivity C-Reactive Protein, or hs-CRP, (in BLOOM and BLOOM-DM) and quality of life. A standardized program of diet and exercise advice was included in the Phase 3 trials in accordance with current FDA guidelines.
Treatment with lorcaserin was well tolerated, resulting in few adverse events with greater frequency than the placebo group. The most frequent adverse events reported in Year 1 and their incidences for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported by a similar proportion of each treatment group.
Echocardiograms were evaluated to assess whether there was an association between lorcaserin and valvular insufficiency. Incidences of new FDA-defined valvulopathy in BLOOM were as follows: lorcaserin 10 mg twice daily (2.7%) and placebo (2.3%) at Week 52 and lorcaserin 10 mg twice daily (2.6%) and placebo (2.7%) at Week 104.
BLOOM evaluated 3,182 patients with an average BMI of 36.2 and baseline weight of 220 pounds. The average age was 44 and 84% were women. Most patients were Caucasian (67%), African-American (19%) or Hispanic (12%). The Week 52 completion rate was higher for patients on lorcaserin (54.9%) compared to patients on placebo (45.1%).
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