Boost for VRX-GSK Epilepsy Drug - Analyst Blog

Valeant Pharmaceuticals International (VRX) and GlaxoSmithKline plc (GSK) recently said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of epilepsy drug, retigabine.

The companies had submitted the Marketing Authorization Application (MAA) for retigabine to the EMA in November 2009. The companies are looking to get retigabine approved as an adjunctive treatment for adults suffering from partial-onset seizures.

Retigabine is referred to as ezogabine in the US and will be marketed under the brand name Trobalt in the European Union (EU). The candidate is being developed under a worldwide license and collaboration agreement between Glaxo and Valeant.

US Status of Ezogabine

The positive recommendation from the CHMP comes as a boost for the companies, particularly in the wake of a complete response letter (CRL) from the US Food and Drug Administration (FDA), received in December last year, for the new drug application (NDA) of ezogabine.

The CRL was for non-clinical reasons and Valeant and Glaxo plan to file a response to the FDA in 2011.

We note that earlier, in August 2010, Glaxo and Valeant had received a positive recommendation from an FDA advisory panel regarding ezogabine. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee had reviewed the safety and efficacy of the drug and voted unanimously in favor of ezogabine's efficacy for the treatment of partial-onset seizures in adults where other treatments failed. However, later during the month, the FDA extended the review date for the candidate by three months.

Competition

Currently available epilepsy treatments include drugs like Pfizer Inc.'s (PFE) Neurontin and Lyrica, Glaxo's Lamictal, UCB Pharma's (UCBJF) Keppra and Johnson & Johnson's (JNJ) Topamax. We believe that ezogabine, once approved, should be able to carve a niche for itself due to its differentiated mechanism of action.

Our Recommendation

We expect investor attention to be focused on the US and EU approvability status of ezogabine/retigabine.

We have Neutral recommendations for both Valeant and Glaxo.