The results of both trials were presented on April 25 in the late-breaker session at the 44th annual meeting of the European Association for the Study of the Liver (EASL) in Copenhagen. The Phase 3 data demonstrate that, with half as many injections, in two pivotal Phase 3 trials, Albuferon achieved efficacy comparable to Pegasys with a positive safety profile. The submission of global marketing applications for Albuferon is planned in fall 2009, following discussions with the FDA and other regulatory authorities. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
LymphoStat-B(R) Phase 3 Results Expected in July and November 2009
HGS expects to report the first Phase 3 data for LymphoStat-B (belimumab) in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. LymphoStat-B is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
$9 Million Milestone Payment Received from GSK Following Initiation of Phase 3 Development of Syncria(R)
HGS received a $9.0 million milestone payment during the first quarter of 2009, following GSK's initiation of a Phase 3 clinical trial program to evaluate Syncria (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Syncria was created by HGS using its proprietary albumin-fusion technology, and licensed to GSK in 2004. HGS is entitled t
|SOURCE Human Genome Sciences, Inc.|
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