GlaxoSmithKline & XenoPort : submission of new drug application requesting FDA approval of Solzira™ for Restless Legs Syndrome

September 16, 2008 - GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.

Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation... GlaxoSmithKline's Press Release - XenoPort's Press Release -

GlaxoSmithKline and Actelion : exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond

Monday 14 July 2008 - GlaxoSmithKline and Actelion to potentially co-develop and co-commercialise other orexin receptor antagonists - GlaxoSmithKline (GSK) and Actelion Ltd (SWX: ATLN) announced that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion’s almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs. Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally... GlaxoSmithKline's Press Release - Actelion's Press Release -

XenoPort and GlaxoSmithKline : XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome

April 17, 2008 - Data from the first pivotal study of XP13512/GSK1838262, a sustained-release investigational compound to treat Restless Legs Syndrome (RLS), showed that it significantly improved the symptoms of moderate-to-severe primary RLS compared to placebo, and was generally well-tolerated when administered once-daily for 12 weeks Data from the PIVOT RLS I (Patient Improvement in Vital Outcomes following Treatment for RLS) clinical trial, formerly designated as study XP052, were presented today at the 60th annual meeting of the American Academy of Neurology (AAN). The investigational compound is being developed by XenoPort (Nasdaq: XNPT) - GSK.

"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in treating the symptoms of RLS in large controlled clinical trials... XenoPort's Press Release -

XenoPort and GlaxoSmithKline, Second Phase 3 Restless Legs Syndrome Trial for XP13512/GSK1838262

Jan 15, 2008 - XenoPort, Inc. (Nasdaq:XNPT) and GlaxoSmithKline (NYSE:GSK) announced positive top-line results from a placebo-controlled Phase 3 clinical trial designed to evaluate the potential of XP13512 (GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome, or RLS... XenoPort's Press Release - GlaxoSmithKline 's Press Release-