Arena Pharmaceuticals, Inc. (ARNA: Quote) and Eisai Inc. (ESALY.PK) said Thursday that lorcaserin, an investigational drug candidate intended for weight management, received positive vote from the US Food and Drug Administration's Advisory Committee. Arena shares soared in after-market trading.
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.
Jack Lief, Arena's President and CEO, said, "The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity. We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application."
Lorcaserin is intended for managing weight, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition.
The drug candidate is a new chemical entity, believed to act as a selective serotonin 2C receptor agonist.
Arena has patents covering lorcaserin in jurisdictions such as the U.S. and Europe. In most cases, these patents are capable of continuing into 2023 without taking into account patent term extensions or other exclusivity Arena may obtain.
While advisory committees provide recommendations to the FDA, the agency makes the final decisions. The Prescription Drug User Fee Act date for the lorcaserin New Drug Application resubmission is June 27, which is the target date for the agency to complete its review.
Arena submitted the original NDA for lorcaserin in December 2009, and the agency issued a Complete Response Letter in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011.
Eisai has exclusive rights to market and distribute lorcaserin in the U.S. subject to FDA approval of the lorcaserin NDA. The European Medicines Agency has accepted the lorcaserin marketing authorization application for filing in March 2012.
Arena said separately that it has expanded the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. In addition to the U.S., the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil.
As per the original agreement, Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution, after 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 U.S. and expanded North and South American territories.
Additionally, Arena will receive an upfront payment and is eligible to receive regulatory and development milestone payments.
ARNA, which closed at $3.66 on Thursday, surged 89.9 percent in the extended session and was trading at $6.95.
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by RTT Staff Writer
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