Arena Pharmaceuticals, Inc. (ARNA - Snapshot Report) recently announced that Eisai Laboratories S. de R.L. de C.V, a subsidiary of Eisai Inc., has submitted a marketing authorization application (MAA) for Belviq (lorcaserin HCl) in Mexico. The application has been filed with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS).
Arena Pharma is looking to get Belviq approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI, >30) or overweight (BMI >27) adults suffering from at least one weight-related co-morbid condition.
Obesity is highly prevalent in Mexican adults. Belviq‘s Mexican approval should boost the drug’s sales potential significantly
We note that Eisai will be responsible for marketing the drug in Mexico on approval. Following approval, Belviq will be manufactured by Arena Pharma at its Switzerland facility.
Arena Pharma is entitled to receive $0.5 million as milestone payment from Eisai, based on the submission of the marketing application in Mexico. Arena Pharma is also eligible to receive payments based on Eisai’s net sales of Belviq.
We note that Eisai has marketing and distribution rights for Belviq in North and South America. Eisai also intends to seek approval of Belviq in Canada and Brazil during the course of the year.
We remind investors that Belviq was approved by the US Food and Drug Administration (FDA) in Jun 2012 as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese or overweight patients.
We remind investors that apart from Belviq, another weight-loss drug, VIVUS Inc.’s (VVUS - Analyst Report) Qsymia, also received approval in the US last year. Orexigen Therapeutics, Inc. (OREX - Analyst Report) is also developing a candidate, Contrave, targeting the lucrative obesity market.
Currently Arena Pharma carries a Zacks Rank #3 (Hold). Comparatively companies like Cytokinetics, Inc. (CYTK - Snapshot Report) look better positioned, carrying a Zacks Rank #1 (Strong Buy).