07:01 ARNA Arena Pharm announces an independent Echocardiographic Data Safety Monitoring Board found no reason to stop ongoing Phase 3 trial BLOOM (14.02 )
Co announces that an independent Echocardiographic Data Safety Monitoring Board found no reason to stop the ongoing pivotal Phase 3 trial, BLOOM. The BLOOM trial is evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The findings of the Board were based on a planned detailed review of unblinded echocardiograms performed after patients completed six months of dosing in the trial. The review was conducted by the Board and confirms that differences, if any, in the rates of FDA-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet predetermined stopping criteria. The review also confirmed that the rate of FDA-defined valvulopathy in the placebo group is consistent with the company's statistical powering assumptions used in the design of the pivotal trial program to monitor patients for any increased risk of developing valvulopathy. ARNA is currently in discussions with the FDA to finalize protocols for two additional Phase 3 pivotal trials scheduled to begin later this year. Under the protocols being finalized with the FDA, the two additional pivotal trials are expected to evaluate daily doses of 20 mg and 10 mg versus placebo over a one-year treatment period, with one of the trials evaluating patients with type 2 diabetes.
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05-Sep-07 07:51 ET In Play Arena Pharm: Initiation details (13.75 ) : As mentioned at 6:50, ThinkEquity initiated ARNA with a Buy and a $22 tgt based on valuation. They believe ARNA's lead product candidate, lorcaserin, holds significant promise to address the growing obesity epidemic. Shares have been under pressure following a negative FDA panel for competitor Zimulti and ahead of an upcoming six-month safety review. They anticipate that this safety look will uncover no issues, but highlight the potential for echocardiograms to be initiated for other Phase III trials.
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24-Aug-07 04:35 ET In Play Arena Pharma profiled in Inside Wall Street - BusinessWeek Online (12.50 ) : BusinessWeek Online reports Arena (ARNA) in September will announce the results of a six-month safety review for its lead drug. All eyes are on the obesity drug, lorcaserin, which is in a large phase III test, with more than 3,000 patients. "We are at an inflection point for the stock in the next month," says Patrick Moriarty of Fortis Securities. "So far, all the data have been positive; lorcaserin could be a multibillion-dollar drug." Moriarty's 12-month target for the stock is 25. Mark Monane, a biotech analyst at Needham, who sees the stock at 23 in a year, also anticipates upbeat news next month. "We do not anticipate any major safety issues." With $371 mln in cash and equivalents and an annual burn rate of $150 mln to $160 mln, the co has a cushion to take it into 2009, says Moriarty, whose firm has a banking relationship with Arena. Lorcaserin is expected to hit the market in 2010.
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