GlaxoSmithKline gains EU appro for epilepsy drug Trobalt; Lovaza patent accord; gets $3.5M from Abbott

Following a positive advisory panel earlier this year, the European Commission has granted marketing authorization for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.

Trobalt is being developed by UK pharma giant GlaxoSmithKline (LSE: GSK) and Canada’s Valeant Pharmaceuticals International (TSX: VRX), which yesterday made a $5.7 billion hostile bid for US drugmaker Cephalon. Under the terms of a 2008 deal, Valeant granted GSK rights to retigabine, VRX698 and the other back-up compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125.0 million. Valeant is also eligible for up to $545.0 million on the achievement of certain milestones and the development of further indications (The Pharma Letter September 8, 2008). . In the USA, where the drug is referred to as Potiga (ezogabine), approval has been delayed by a complete response letter from the Food and Drug Administration (TPL December 2, 2010).

Analysts have forecast peak sales for the drug - the first potassium channel opener in development for epilepsy - of as little as $200 million and up to $800 million.