Eisai's subsidiary Eisai Laboratorios has submitted a marketing authorization application (MAA) for Belviq (lorcaserin HCl) with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico.
Arena Pharmaceuticals's internally discovered drug, Belviq, is intended to act as an adjunct to a reduced-calorie diet and high physical activity for chronic weight management in adult patients with the body mass index (BMI) of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.
Belviq is considered to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.
Eisai senior vice president Frank Ciriello said that the company is committed to patients' medical needs as a part of the human health care corporate mission.
"We believe that Eisai has an opportunity with BELVIQ to bring a new medical option to help address the needs of patients affected by overweight and obesity in Mexico," Ciriello added.
Arena will receive $500,000 as a milestone payment from Eisai following the submission of MAA.
Up on the approval, Arena will manufacture Belviq at its facility in Switzerland and sell the product to Eisai while Eisai deals with the regulatory approval and distribution of Belviq in Mexico.
Arena Pharmaceuticals president and CEO Jack Lief said that the company looks forward to the opportunity to help address the unmet medical need by bringing Belviq to patients suffering from chronic weight management in Mexico.
"We plan to commercialize BELVIQ globally through collaborations with organizations such as Eisai that are committed to and have proven capabilities in serving patients and physicians," Lief added.
Arena will receive payments based on Eisai's net sales of Belviq and also be eligible to receive regulatory and development milestone payments.
Apart from Mexico, Eisai has marketing and distribution rights in most of North and South America and plans to submit MAAs for Belviq in Canada and Brazil in 2013.
