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Arena Pharma, Eisai expand lorcaserin marketing & supply agreement

San Diego
Monday, May 14, 2012, 13:00 Hrs  [IST]

Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc. and Eisai Inc. has expanded the marketing and supply agreement for lorcaserin, an investigational drug candidate intended for weight management.

In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US Food and Drug Administration (FDA).

“Obesity is a condition that transcends geographic boundaries,” said Lonnel Coats, president and chief executive officer, Eisai Inc. “Through this expanded agreement, we believe Eisai has an opportunity to help address the significant and growing need for medical obesity treatments by bringing a potential new option to physicians and patients throughout the Americas.”

As in the original agreement, Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution, subject to applicable regulatory approvals in the territories. Under the expanded agreement, Arena is eligible to receive increased payments based upon Eisai's net sales of lorcaserin in the United States and expanded North and South American territories. Additionally, Arena will receive an upfront payment and is eligible to receive regulatory and development milestone payments.

“We believe in Eisai's human health care mission to help satisfy unmet medical needs and increase benefits to patients and their families,” said Jack Lief, Arena's president and CEO. “The expanded commercialization agreement further supports our belief in the medical potential of lorcaserin in the United States and beyond.”

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents or patent applications that cover lorcaserin in the United States, Europe, Canada, Mexico, Brazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

Arena submitted the original New Drug Application (NDA) for lorcaserin to the FDA in December 2009, and the agency issued a Complete Response Letter (CRL) in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011, and the agency assigned a Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute lorcaserin in most of North and South America, including the United States, Canada, Mexico and Brazil, subject to approval by the applicable regulatory authorities. In addition, the European Medicines Agency accepted the lorcaserin marketing authorization application for filing in March 2012. Arena owns rights to market and distribute lorcaserin in Europe and other territories.

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.

Eisai Inc. commercially include neurology, gastrointestinal disorders and oncology/critical care.

 

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