Human Genome/GlaxoSmithKline lupus drug Benlysta disappoints in Ph III; Updates on Seattle Genetics and Ligand milestones

USA-based Human Genome Sciences and UK drug giant GlaxoSmithKline yesterday revealed top-line secondary endpoints from BLISS-76, the second of two pivotal Phase III trials of Benlysta (belimumab) in seropositive patients with systemic lupus erythematosus (SLE), which were somewhat disappointing, given that the drug had already met its primary efficacy endpoint at week 52 in both BLISS-52 and BLISS-76, as announced in July and November 2009.

The findings were the second disappointment this week for HGS. As reported yesterday, Swiss drug major Novartis withdrew a marketing application to sell the hepatitis C drug Jouleferon (albinterferon), which the companies were jointly developing, in Europe. The US firm's stock fell as much as 10% but settled down 6% lower at $29.61 at 4 pm New York time in Nasdaq Stock Market composite trading.

However, RBC Capital Markets analyst Michael Yee said a modest drop in the stock presents a buying opportunity long-term, because he expects the drug will still be Food and Drug Administration-approved and remain a significant blockbuster." In a note to clients, Mr Yee pointed out that FDA approval will be based on the drug meeting its goals at 52 weeks, though the weakening effect may be questioned by regulators or an FDA panel. He also said HGS remains a takeover target by partner GSK, as well as rival drugmakers Amgen, Johnson & Johnson and Abbott Laboratories, among others.