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Arena raises funds, gets PDUFA date for obesity drug

World News | January 12, 2012


Kevin Grogan

Arena raises funds, gets PDUFA date for obesity drug

Arena Pharmaceuticals, which has just had its resubmitted application for the weight-loss drug lorcaserin accepted by US regulators, has completed a $33 million fundraising.

The company has sold around 9.95 million shares priced at nearly $1.66 each, plus preferred convertible stock to US healthcare investment organisation Deerfield Management. Some $5 million of the proceeds to prepay a portion of the loan ahead of schedule (June 2013) under the existing facility it has with Deerfield.

The company also will issue warrants to Deerfield to purchase about 8.6 million shares with an exercise price of $1.75. In exchange, Deerfield will cancel warrants to purchase 11.8 million shares at $5.42 each and 1.8 million shares at $3.45 each.

The fundraising comes a day after Arena and partner Eisai announced that the US Food and Drug Administration accepted their refiled New Drug Application for lorcaserin, which was rejected by the agency in October 2010.

Last week, Arena submitted its reply to the complete response letter from the FDA which cited a number of reasons for its decision, notably concerns about tumours found in animal studies. The response includes data and analyses that were not incorporated in the original New Drug Application, including the results of the Phase III BLOOM-DM trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes.

Arena says the FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act target date of June 27. Earlier this week, the agency told another company looking to get the green light for an obesity drug, Vivus, to remove a restriction against use by women of childbearing potential from the proposed label of its weight loss drug Qnexa (phentermine/topiramate); the latter, which was also rejected first time in 2010, will be reviewed by an advisory committee on February 22.

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