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Biotech / Medical : NKTR Drug delivery Company

NKTR 54.29

+0.6%

10:05 AM EST

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To: Ian@SI who wrote (150)	9/29/2006 11:27:15 AM
From: tom pope	of 507

Merrill: Reduced competitive risk for Sulonex Eli Lilly announced that the FDA has requested an additional three year phase III trial for Arxxant (ruboxistaurin), which received an approvable letter in August for the treatment of diabetic retinopathy. The trial would take about 5 years to complete, if Lilly decides to go forward, thereby lowering the potential for any near-term off-label use in diabetic nephropathy and thus reducing the competitive risk for Keryx’s lead candidate Sulonex. Maintain our Buy. Less potential for off-label use in diabetic nephropathy Arxxant had shown some encouraging results in reducing albuminuria in a pilot study but Lilly has not to our knowledge advanced it to phase III development in diabetic nephropathy. Its setback in diabetic retinopathy may further reduce the likelihood of progress in diabetic nephropathy. Ahead of other potential competitor Another potential competitor is Speedel’s Avosentan, an oral endolthin A receptor antagonist that is in a large phase III morbidity and mortality study that is not expected to be completed until 2009. We estimate that Keryx’s Sulonex, currently in a large phase III trial, has about a 1-2 year lead on Avosentan. Sulonex on track Keryx continues to aggressively enroll patients in its phase III/IV pivotal program for Sulonex in the treatment of diabetic nephropathy. It expects to complete enrollment of its 1000-patient phase lll trial being conducted under a SPA around the end of the year and we expect data from the trial late next year. Reiterate our Buy rating KERX is a top small cap biotech pick with a potential $1B product in Sulonex, which is unpartnered, for the treatment of diabetic nephropath

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