Arena Pharma (ARNA) Reports Additional Belviq Coverage by Health Plans; Updates on Lorcaserin

As previously announced, Arena Pharma (Nasdaq: ARNA) is scheduled to present a corporate overview today at the 32nd Annual J.P. Morgan Healthcare Conference. The corporate overview will include certain new and updated information as highlighted below. BELVIQ US Commercialization Update We previously announced that Eisai planned to increase its BELVIQ® (lorcaserin HCl) sales force to approximately 400 representatives by December 2013, doubling the size of the sales force from when BELVIQ became available in June 2013. The approximately 400 sales representatives are now detailing BELVIQ, which will enable Eisai to reach approximately 65,000 physicians in the United States. Also, BELVIQ is now covered by additional commercial and employer health plans, according to Fingertip Formulary, LLC. While the exact reimbursement coverage for BELVIQ varies by patient, improved access means more patients will receive coverage support from their health plan. Regulatory Filing in South Korea Ildong Pharmaceutical Co., Ltd., filed in November 2013 for marketing authorization of BELVIQ as a treatment for chronic weight management with the South Korean Ministry of Food and Drug Safety. BELVIQ was submitted for marketing authorization in South Korea as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult obese patients (initial body mass index, or BMI, > 30 kg/m2), or overweight patients (initial BMI > 27 kg/m2) in the presence of at least one weight-related comorbid condition. Lorcaserin for Smoking Cessation As previously announced, we plan to initiate a Phase 2 clinical trial in the first half of 2014 to evaluate the potential of lorcaserin as a drug candidate for smoking cessation. We expect to enroll approximately 600 patients in this 12-week trial. We and Eisai will share equally the expenses for this trial. Co-Administration of Lorcaserin and Phentermine Eisai has initiated dosing in a pilot study of 12-week duration to preliminarily assess as the primary outcome the short-term safety and tolerability of lorcaserin and phentermine when co-administered. This randomized, double-blind and parallel-group study will enroll approximately 225 overweight and obese adults. Patients will be randomized to one of three treatment arms in a 1:1:1 ratio, and will receive lorcaserin 10 mg twice daily, lorcaserin 10 mg twice daily in combination with phentermine 15 mg twice daily, or lorcaserin 10 mg twice daily in combination with phentermine 15 mg once daily. Eisai is responsible for the expenses of this study. Lorcaserin Extended Release Once-Daily Formulation We have completed an initial study to evaluate the safety, tolerability and pharmacokinetic properties of different formulations of lorcaserin 20 mg extended release tablets to select a once-daily formulation for further development. We and Eisai will share equally the expenses for the development work related to the once-daily formulation. Lorcaserin Cardiovascular Outcome Trial Eisai plans to initiate enrollment this month of approximately 12,000 patients in Camellia (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients), a cardiovascular outcome trial required by the US Food and Drug Administration, or FDA, as a post-marketing commitment. Camellia is a randomized, double-blind, placebo-controlled trial that will enroll patients with cardiovascular disease or multiple cardiovascular risk factors. The trial is expected to run for approximately five years. The FDA required portion of the trial is designed to evaluate lorcaserin’s effect on the incidence of major adverse cardiovascular events, or MACE, (non-fatal myocardial infarction, non-fatal stroke and cardiovascular death) compared to placebo, with a non-inferiority margin for the hazard ratio of 1.4. We and Eisai will be responsible for 10% and 90%, respectively, of the expenses for the FDA required portion of the trial. In addition, Camellia will also evaluate whether lorcaserin reduces the incidence of conversion to type 2 diabetes in patients without type 2 diabetes at baseline and the incidence of MACE+ (MACE or hospitalization for unstable angina or heart failure, or any coronary revascularization), both as compared to placebo. We and Eisai will share equally the expenses for this non-FDA required portion of the trial up to $40.0 million each, and Eisai will be responsible for 100% of such expenses thereafter. APD811 We are planning to initiate a Phase 2 clinical trial of APD811, an orally available agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension, in the first half of 2014. APD334 As previously announced, we have completed a Phase 1 clinical trial of APD334, an orally available agonist of the sphingosine 1-phosphate subtype 1, or S1P1, receptor intended for the treatment of a number of conditions related to autoimmune diseases. This randomized, double-blind and placebo-controlled trial evaluated the safety, tolerability and pharmacokinetics of single-ascending doses of APD334 in 40 healthy adult volunteers. In the trial, APD334 demonstrated favorable pharmacokinetic and pharmacodynamic effects, a dose-responsive reduction in blood lymphocyte count, and a slowing of heart rate (bradycardia) that appears comparable to other S1P1 agonists. The terminal half-life was approximately 35 hours. We plan to initiate a Phase 1 multiple-ascending dose trial of APD334 in 2014. APD371 We initiated dosing in a Phase 1 clinical trial of APD371, an orally available agonist of the cannabinoid-2 receptor intended for the treatment of pain. This randomized, double-blind and placebo-controlled Phase 1 trial will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD371 in up to 56 healthy adult volunteers.

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• Jabil falls after placing CEO on paid leave amid internal investigation
• Nordstrom (JWN) CEO Erik Nordstrom Reports 7.45% Stake, Seeks to Finance Potential Deal with Debt/Equity
• FREYR Battery (FREY) Appoints Todd Kantor, Tore Ivar Slettemoen, and David Manners to its Board