Profile: Arena Pharmaceuticals Inc (ARNA.O)

Arena Pharmaceuticals, Inc. (Arena), incorporated in April 14, 1997, is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. The Company’s drug candidate, lorcaserin hydrochloride (lorcaserin), is being investigated in a Phase III clinical trial program for the treatment of obesity. It has a pipeline of compounds that target G protein-coupled receptors (GPCRs), and includes compounds being evaluated independently and with its partners, including Merck & Co., Inc. (Merck) and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Ortho-McNeil-Janssen). On January 9, 2008, the Company acquired from Siegfried Ltd certain drug product facility assets, including a licensed production facility, fixtures, equipment, other personal property and real estate assets in Zofingen, Switzerland.

The Company has other internal programs, which include programs evaluating APD791, APD916 and APD811, as well as earlier-stage research programs. APD791 is an oral drug candidate that Arena discovered and is investigating for the treatment and prevention of arterial thrombosis and other related conditions. APD916 is an oral drug candidate, which is investigated for the treatment of narcolepsy and cataplexy, and potentially for other indications. The Company is also developing APD811, its pre-clinical drug candidate for the treatment of pulmonary arterial hypertension.

In addition to internal programs, the Company has partnerships with pharmaceutical companies, including Ortho-McNeil and Merck. Arena’s Merck partnership is focused on niacin receptor agonists as treatments for atherosclerosis and other disorders. In February 2009, Merck initiated a Phase II clinical trial of a second-generation oral niacin receptor agonist under its partnership. Arena’s Ortho-McNeil-Janssen partnership is focused on receptor agonists of an orphan GPCR, known as GPR119, as treatments for diabetes and other disorders. In December 2008, Ortho-McNeil-Janssen initiated a first-in-human Phase I clinical trial of APD597, an oral drug candidate discovered by Arena.

Lorcaserin

Lorcaserin is a selective serotonin 2C receptor agonist. The Company conducted pre-clinical studies examining the activity and serotonin receptor subtype specificity of lorcaserin. As of December 31, 2008, the Company was investigating lorcaserin in a Phase III pivotal trial program for the treatment of obesity.

BLOOM, the first of the three clinical trials, is a randomized, double-blind and placebo-controlled trial evaluating a 20 milligram dose (10 milligram dosed twice daily) of lorcaserin versus placebo over a two-year treatment period in obese patients (body mass index of 30 to 45) with or without co-morbid conditions and overweight patients (body mass index of 27 to less than 30) with at least one co-morbid condition. The primary efficacy endpoint is the proportion of patients with a 5% or greater weight reduction from baseline at week 52 as compared to placebo. In December 2007, Arena initiated BLOSSOM and BLOOM-DM, the second and third Phase III clinical trials. These trials are one-year, randomized, double-blind and placebo-controlled clinical trials. In June 2008, BLOSSOM completed enrollment with 4,008 patients.

The BLOOM-DM trial is evaluating 10 milligram and 20 milligram daily doses (10 milligram dosed once or twice daily) of lorcaserin versus placebo over a one-year treatment period in overweight and obese patients with type 2 diabetes at about 60 sites in the United States. The complete lorcaserin Phase III pivotal program consists of the BLOOM and BLOSSOM trials and has enrolled 7,189 patients.

APD791

Arena’s anti-thrombotic drug candidate, APD791, has completed Phase Ia and Phase Ib clinical trials. APD791 is an oral and selective inverse agonist of the serotonin 2A receptor intended to lower the risk of arterial thrombosis and related conditions by reducing the amplification of platelet aggregation, arterial constriction and intimal hyperplasia, or thickening of the vessel wall, mediated by serotonin.

In July 2007, Arena initiated a single-ascending dose Phase Ia clinical trial evaluating APD791 in healthy volunteers. This Phase Ia trial is a randomized, double-blind and placebo-controlled, single-ascending dose trial in 90 healthy male and female volunteers. The Phase Ib trial, initiated in January 2008, is a randomized, double-blind, placebo-controlled, multiple-ascending dose trial in 50 healthy male and female volunteers.

APD125

APD125 is an internally discovered drug candidate that is evaluated for the treatment of insomnia. In December 2008, the Company announced preliminary data from a Phase IIb clinical trial of APD125.

The Company competes with Abbott Laboratories, Hoffmann-La Roche Inc. and GlaxoSmithKline Consumer Healthcare.