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UK's NICE Rebuffs Glaxo's New Lupus Drug Benlysta

LONDON -(Dow Jones)- Lupus drug Benlysta from GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) doesn't represent value for money and should therefore not be made available on the publicly-funded National Health Service, Britain's healthcare watchdog NICE said on Friday. Benlysta, or belimumab, is the first new lupus treatment in 50 years. It won U.S. marketing approval in March and European approval in July. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated five million people worldwide have the disease. In draft guidance, the U.K.'s National Institute for Health and Clinical Excellence said, "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE [Systemic lupus erythematosus], including the views of people with the condition, those who represent them, and clinical specialists. "The evidence considered did not persuade the committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high." NICE also said Benlysta should be compared with rituximab, sold by Roche Holding AG (ROG.VX), because some people with severe lupus currently receive rituximab, although it isn't licensed for this use. However, NICE noted there were no reliable data to show the relative efficacy of the two drugs. "Whilst recognizing the severity of the disease, the committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation," the agency said. --By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@dowjones.com

Stock News for Human Genome Sciences (HGSI)
DateTimeHeadline
08/03/201203:00:56GlaxoSmithKline Completes Acquisition of Human Genome Sciences
07/30/201209:06:49GlaxoSmithKline Gets 79% Tenders for Human Genome Sciences Offer
07/15/201219:10:13Glaxo Eyes Human Genome Sciences for $2.6 Billion
07/15/201215:49:18Sources Say GlaxoSmithKline in Talks to Acquire Human Genome...
07/11/201212:36:14Glaxo To File Experimental Diabetes Drug Albiglutide In Early...
07/10/201208:38:08Human Genome: FDA Sets Dec. 15 Action Date For Anthrax Treatment...
07/03/201217:08:09GlaxoSmithKline Readies Candidates to Replace Human Genome's...
06/29/201209:24:03Glaxo Keeps Pressure On Human Genome By Extending Offer To July...
06/29/201207:35:49GlaxoSmithKline Sets July 20 For Expiration Of Tender Offer To...
06/15/201210:42:11GSK Gets Renewed Invitation to Human Genome Sciences Strategic...
06/08/201209:10:55GlaxoSmithKline Extends HGS Offer To June 29
06/07/201211:43:24Glaxo Seen Likely to Extend Hostile Tender Offer for Human Genome
05/30/201211:58:59GlaxoSmithKline Is Said To Plan Effort To Replace Human Genome...
05/23/201209:12:46Glaxo Amends Offer To Address HGS Shareholder Rights Plan
05/17/201217:45:35ADR Report: Shares Lower As Euro-Zone Worries Loom
05/17/201213:54:16GlaxoSmithKline Offer To Acquire HGS Represents Full, Fair Value
05/17/201207:55:44Human Genome Adopts Poison Pill With 15% Trigger To Deter Glaxo
05/09/201209:33:24WSJ BLOG/Health: A.M. Vitals: GSK's Hostile Human Genome Bid;...
05/09/201205:02:12Glaxo Goes Direct To HGS Shareholders With Hostile Offer
05/09/201202:48:24GlaxoSmithKline To Launch $13/Share Tender Offer For To Buy HGS

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