Replies to post #586 on Arena Pharmaceuticals, Inc. (ARNA)

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DJ UPDATE: FDA: Arena's Weight-Loss Drug Lorcaserin Meets One Standard

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(Updates with additional information from FDA, stock price and company comment starting in the second paragraph.)


By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES


WASHINGTON (Dow Jones)--The Food and Drug Administration said Tuesday a proposed weight-loss drug being developed by Arena Pharmaceuticals Inc. (ARNA) met one of the agency's effectiveness standards "by a slim margin."

But the agency said clinical studies of the drug, lorcaserin, showed the product didn't meet another standard that requires that the difference in the average weight loss be at least 5% between patients being treated with the active drug compared to placebo, or fake drug. The agency said the average weight loss with lorcaserin was about 3% greater than the average weight loss for patients given a placebo.

However, the FDA said a product is considered effective if it meets at least one of the criteria after one year of treatment.

Shares of Arena plunged on the news, recently trading down 36% to $4.38 on more than five-times average share volume. The shares are close to levels last seen in mid-July, after Vivus Inc.'s (VVUS) experimental obesity drug was rejected by a similar FDA panel. That panel's reluctance to support Qnexa, largely due to a lack of long-term data, boosted Wall Street's confidence in Arena's drug.

Lorcaserin did meet a standard that requires that a proportion of people who lose at least 5% of their body-weight in the active drug group be at least 35% of patients and approximately double the proportion of patients in the placebo group. The agency said about 23% of patients in the placebo group lost 5% or more of their body weight after one year compared to 47% of people being given lorcaserin twice a day and 40% of people treated with lorcaserin once daily.

Lorcaserin faces a review Thursday by the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on whether it thinks the benefits of lorcaserin outweigh the potential risks "when used long-term in a population of overweight and obese individuals."

The FDA posted a review of lorcaserin to its website Tuesday in preparation for the panel meeting. The FDA usually follows panel recommendations but it's not required to do so.

The agency said studies of the product in rats showed there was an excess of breast tumors when dosed at higher levels than a clinical dose that would be used in humans. The agency said there was no imbalances in reports of cancer among people treated with lorcaserin compared to a placebo.

Arena Pharmaceuticals, in a background document also posted to FDA's website Tuesday, said lorcaserin "demonstrated clinically significant and statistically significant weight reduction, accompanied by significant improvements in a panel of cardiovascular risk factors." The company also said it would conduct additional clinical studies of the drug if it were to be approved.


-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]
(Thomas Gryta in New York contributed to this story)