Eisai Laboratorios S. de R.L. de C.V., a subsidiary of Eisai Inc., has submitted a marketing authorisation application (MAA) for Belviq (lorcaserin HCl) in Mexico with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS).

The intended indication for Belviq is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on the MAA submission, Arena Pharmaceuticals, Inc will receive a milestone payment of $500,000 from Eisai.

"We look forward to the opportunity to help address this unmet medical need by bringing Belviq to patients in Mexico who can benefit from treatment for chronic weight management," said Jack Lief, Arena's president and chief executive officer. "We plan to commercialise Belviq globally through collaborations with organisations such as Eisai that are committed to and have proven capabilities in serving patients and physicians."

Approximately 30 per cent of adults in Mexico are obese and 70 per cent are overweight or obese. The rapidly increasing prevalence of overweight and obese patients is leading to a large health and economic burden in Mexico.

"Eisai is committed to keeping patients' medical needs at the forefront of all that we do, as part of our human health care corporate mission," said Frank Ciriello, senior vice president, Eisai Inc. "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."

Eisai is responsible for the regulatory approval and, ultimately, marketing and distribution of Belviq in Mexico. Subject to approval, Arena will manufacture Belviq at its facility in Switzerland and sell finished commercial product to Eisai for distribution in Mexico. Arena is eligible to receive payments based upon Eisai's net sales of Belviq and is also eligible to receive regulatory and development milestone payments.

Beyond Mexico, Eisai has marketing and distribution rights in most of North and South America and also plans to submit MAAs for Belviq in Canada and Brazil this year. In addition, Arena has granted marketing and distribution rights to Ildong Pharmaceutical Co., Ltd., for South Korea and plans to enter into additional collaborations to commercialise Belviq outside of these territories. Arena has composition of matter patents for Belviq issued in major jurisdictions globally that, in most cases, are capable of continuing into 2023, and has filed applications for patent extension in the United States, which, if granted, will extend the patent term for Belviq into 2026.

Belviq (pronounced "BEL-VEEK") is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. The exact mechanism of action of Belviq is not known.

Belviq currently is not available. Belviq is approved by the US Food and Drug Administration to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of: 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

Arena is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs.