Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)

Arena Pharmaceuticals, Inc. (Arena), incorporated on April 14, 1997, is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors (GPCRs), in four therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. After completing various studies, analyses and other activities in response to the lorcaserin CRL, in December 2011, the Company resubmitted the lorcaserin NDA. Its wholly owned subsidiary, Arena Pharmaceuticals GmbH (Arena GmbH), has granted Eisai Inc., rights to commercialize lorcaserin in the United States and its territories and possessions, subject to the United States Food and Drug Administration (FDA) approval of the lorcaserin NDA. As of December 31, 2011, the Company’s earlier-stage programs included APD811, an internally discovered, orally available agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension. APD811 completed a single-dose, PhaseI clinical trial during the year ended December 31, 2011. Its internally discovered, oral drug candidates also include temanogrel, which was formerly called APD791, and nelotanserin, which was formerly called APD125. Temanogrel is an inverse agonist of the serotonin 2A receptor intended for the treatment of arterial thrombosis and other related conditions and has completed Phase Ia and Phase Ib clinical trials. Nelotanserin is a serotonin 2A receptor inverse agonist that the Company previously studied for insomnia, and hadcompleted Phase IIa and Phase IIb clinical trials in 2011.

The Company has the rights for all of its programs and drug candidates, with the exception of Eisai’s right to commercialize lorcaserin in the United States. The Company’s drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss. The Company has evaluated the safety, pharmacokinetics and pharmacodynamics of lorcaserin in 19 clinical trials: seven Phase I trials, two Phase II trials, three Phase III trials, a bioavailability study, a mass balance study, an ECG/QT trial, two drug interaction trials, an abuse potential trial, and a study of energy intake and energy expenditure. The lorcaserin Phase III clinical trial program consisted 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 non-diabetic patients, who were obese or patients who were overweight and had at least one weight-related co-morbid condition other than diabetes: 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 obese and overweight patients with type 2 diabetes over a one-year treatment period.

The Company competes with Roche Group, GlaxoSmithKline Consumer Healthcare, VIVUS Inc. and Orexigen Therapeutics, Inc.

Web site: http://www.arenapharm.com

Last updated July 30, 2012