Arena Says Obesity Drug Candidate Receives Positive Vote From FDA Advisory Panel

Arena Pharmaceuticals, Inc. (ARNA) 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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Centers for Disease Control and Prevention or CDC director, Rochelle Walensky, has initiated a reorganization of the public health agency noting that it failed to reliably meet expectations during the coronavirus pandemic period, reports said. The proposed changes for a reset in the agency are expected to help it respond quicker to new health threats. While reporting financial results for the second quarter on Thursday, department store chain Kohl's Corp. (KSS) slashed its adjusted earnings and sales growth guidance for the full-year 2022. For fiscal 2022, the company now projects adjusted earnings in a range of $2.80 to $3.20 per share on a net... Apple Inc. is planning to hold a launch event on September 7 to unveil its latest iPhone 14 line, Bloomberg reported citing people with knowledge of the matter. The tech major is also expected to roll out its latest version of three Apple Watch models including Series 8. The new products, which also include multiple new versions of Macs, and low and high-end iPads, are likely to reach stores...
Follow RTT