ADELPHI, Maryland (Reuters) – Arena Pharmaceuticals Inc suffered a above setback on Thursday if U.S. admiral alone its proposed weight-loss bolus amidst apropos that tumors in rats ability announce a accident of blight in humans.
Lorcaserin, Arena's a lot of avant-garde biologic candidate, is the additional diet biologic to blunder in a chase a part of three baby companies to barrage the aboriginal new decree diet biologic in a decade.
Arena shares fell about 40 percent in after-hours trading Thursday to $2.28. The shares had been apoplectic in accustomed trading awaiting after-effects of the advising meeting.
The banal is down 67 percent from Monday's close, with abounding investors beat the shares on Tuesday afterwards the U.S. Food and Biologic Administration issued abstracts adopting assurance apropos that included the rat tumors and anamnesis loss.
Shares of Orexigen Therapeutics Inc, still to face an advising console on its diet pill, rallied 38 percent to $6.77 on Nasdaq.
The advising board voted 9-5 that abeyant risks from abiding use of Arena's lorcaserin outweighed accessible allowances from bashful weight loss. Panelists said they were borderline if tumors in lab rats meant the biologic would access academician or breast cancers in people.
"I do anticipate (lorcaserin) is promising, but there's too abundant ambiguity at this time," said Jessica Henderson, the panel's customer representative.
An FDA console in July apprenticed adjoin approval of a diet biologic from Vivus Inc afterwards delivery affair about depression, anamnesis accident and abeyant bearing defects. Vivus shares fell 1.4 percent on Thursday.
Orexigen's drug, Contrave, is accepted to face FDA admiral in December.
MORE STUDY
The able console alleged on Thursday for added abstraction of Arena's lorcaserin in humans with diabetes, top claret burden and added bloom problems, to bigger reflect patients who would use the biologic if it was approved.
The FDA usually follows console recommendations. A final cardinal is due October 22.
The anticipation of lorcaserin anytime extensive the bazaar is "really small," BMO Capital Markets analyst Jason Zhang said afterwards the console vote.
"They can run a ample balloon in a high-risk accumulation and see if that will appearance agnate ability but a bigger accident profile. That's a little remote," Zhang said.
Arena said its biologic was safe at recommended doses and would advice activity the U.S. blubber epidemic. Japan's Eisai Co holds the U.S. business rights to lorcaserin.
"I just couldn't get over that we didn't accept a broader citizenry that was adumbrative of humans a lot of acceptable to get this (drug)," said Dr. Lamont Weide, an advising console affiliate and arch of diabetes and endocrinology at the University of Missouri in Kansas City.
Arena is belief lorcaserin in ample and adipose diabetics and said it expects after-effects afterwards this year.
The companies accept the biologic has "a absolute benefit-risk profile" and Arena "will plan carefully with the FDA" on its review, Arena Arch Executive Jack Lief said in a account handed to reporters anon afterwards the board vote.
Consensus anticipation abstracts from Thomson Reuters showed analysts accepted Arena's biologic could ability aiguille anniversary sales of $822 actor if it accomplished the market.
Drugmakers accept bootless for decades to aftermath a bolus to advice humans afford a cogent bulk of weight after austere ancillary effects.
Risks of accepted options were accent on Wednesday if U.S. admiral agreed tougher activity was bare on Abbott Laboratories Inc's diet biologic Meridia, but breach on whether it should be banned.
BLOCKING APPETITE
Arena's lorcaserin was advised to block appetence signals in the academician in a agnate way to the now-withdrawn fenfluramine in the fen-phen diet-drug cocktail. The Arena biologic is added careful in the receptors it affects and the aggregation says studies accept not begin any of the heart-valve problems with lorcaserin that were affiliated to fenfluramine.
Arena aswell argued the allegation of rat tumors did not administer to humans because they resulted from top doses or biological mechanisms specific alone to rodents. No access in blight cases was apparent in people.
Patients who took 10 milligrams of lorcaserin alert circadian for a year absent about 5.8 percent of their physique weight on average, FDA reviewers said. Placebo patients absent 2.5 percent.
Prescription weight-loss drugs accept bootless to accretion abundant absorption in the United States, admitting the abeyant for able sales in a nation area two-thirds of the citizenry are ample or obese. The accepted U.S. diet biologic bazaar is baby at about $381.5 actor in 2009, according to abstracts from IMS Health.
Arena is developing added drugs for analysis of claret clots, beddy-bye disorders and pulmonary arterial hypertension, but all are in aboriginal testing.
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