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GlaxoSmithKline Presents Innovative Neuroscience Pipeline
Date:12/13/2007

used cholinesterase inhibitor, to placebo demonstrated that over a 24-week treatment period, patients receiving '457 had similar improvements in global function and cognitive function compared to patients receiving donepezil.

These data demonstrate the potential of '457 for use in the treatment of Alzheimer's disease. Two large phase II trials investigating the potential of '457 as monotherapy and as adjunctive therapy in patients with mild-to- moderate Alzheimer's disease are expected to start next year.

Also for the treatment of Alzheimer's disease, initial results from the ongoing phase III development program for rosiglitazone XR are anticipated in 2009. Rosiglitazone XR is being studied as monotherapy, compared with donepezil and placebo. Two additional phase III studies with rosiglitazone XR as an adjunct therapy are ongoing.

1838262 - Potential new treatment for RLS, neuropathic pain and migraine:

Neuropathic pain is caused by nerve injury resulting from conditions such as shingles and diabetes. Gabapentin is one of the most widely used treatments for neuropathic pain; however it is only effective in some patients. GSK, in collaboration with XenoPort, is developing a new chemical entity, 1838262 (XP13512), which utilizes a novel transport mechanism to enable '262 to be efficiently absorbed into the body where it is converted to gabapentin. The improved drug exposure provided by '262 offers the potential for improved treatment of neuropathic pain and possibly other neurological disorders.

GSK and XenoPort are developing '262 for a number of different indications. The most advanced of these is for the treatment of restless legs syndrome (RLS). GSK expects to file '262 for use in this indication with the FDA in the third quarter of 2008.

As a result of published studies demonstrating that gabapentin has potential benefit in the prophylactic treatment of migraine attacks and chronic daily headaches, together with the fav
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