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Arena, Eisai Diet Drug Less Concentrated In Human Brain Than Rat

By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Arena Pharmaceuticals Inc. (ARNA) and Eisai Co. (ESALY, 4523.TO) said that a study of the diet pill lorcaserin showed that the drug seems to concentrate in the human brain less than it does in rats. The data is part of the companies' work to respond to Food and Drug Administration concerns that led to the pill being rejected for approval last year. The agency requested multiple sets of new data including studies related to breast cancer and brain cancer occurring in rats, and more information on heart-related risk. The company said that the effort to address other FDA concerns is ongoing. Arena conducted the study by measuring lorcaserin concentrations in human cerebrospinal fluid and then seeing how that compared to the amount of the drug in blood plasma. The company used an "apparent consistent relationship" of the amount of lorcaserin in the brain in relation to the spinal fluid of mice, rats and monkeys. That ratio was used to predict the corresponding amount of the drug in the human brain using the spinal fluid measurements. Using the new data and previous information, Arena estimates that human brain exposure to the drug is 1.7 times the plasma concentration at normal dose. In rats with a much higher dose, but which didn't have brain cancer, the ratio was 24 times. Arena noted that its estimates in the study are based on "certain assumptions and extrapolations" and the FDA may have different findings when looking at the raw data. The agency also may not view the company estimates as "reliable or predictive of the safety margin," Arena said in a statement. -By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

Stock News for Arena (ARNA)
DateTimeHeadline
03/28/201505:21:38Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely
03/27/201507:59:45Arena Investors Need To Pay Attention To Competition
03/23/201508:49:56Arena Pharmaceuticals Could Have Better Luck In Quarter 2
03/23/201506:51:27Vivus: Qsymia Sales Slip, Company Needs To Shift Into Gear
03/22/201512:56:03Biotech Stocks: 2 to Avoid, 1 to Buy
03/21/201505:11:59Orexigen - Contrave Scripts Up, Equity Down, Approval In Europe...
03/18/201517:46:50Statement of Changes in Beneficial Ownership (4)
03/16/201509:51:47Vivus' Qsymia Breaks 3-Week Stagnancy, Could Start Upward Trend
03/16/201508:27:08Who Will Be Orexigen's Ex-U.S. Partner? My Bet Is On Takeda
03/15/201520:45:03Orexigen - Contrave Scripts Rise Over 6%, But The Focus Is On...
03/13/201517:44:08Vivus - Qsymia Scripts Pass 11,000 For First Time In 2015
03/11/201508:26:11Arena Scripts Still Slower Than Needed - Are Downgrades In The...
03/10/201502:21:06Novo Nordisk Readies For Saxenda Launch - Investors Need To Keep...
03/10/201502:07:01Arena - Belviq Ads Slow Substantially - Eisai Promises Seem To...
03/09/201510:37:08Orexigen's Contrave Blunder Due To Weak Intellectual Property...
03/04/201517:55:55Statement of Changes in Beneficial Ownership (4)
03/03/201516:26:44Current Report Filing (8-k)
03/02/201520:07:03Arena's (ARNA) CEO Jack Lief on Q4 2014 Results - Earnings Call...
03/02/201516:01:00Arena Pharmaceuticals Provides Corporate Update and Reports Fourth...
03/01/201517:35:17Notable earnings after Mondayâs close

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