GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX) recently announced that the US Food and Drug Administration (FDA) has extended the review date for their epilepsy candidate, ezogabine, by three months. Glaxo and Valeant are seeking approval for ezogabine both in the US and the EU for the treatment of adults with partial-onset seizures.
The FDA is yet to finish reviewing the New Drug Application (NDA) for the candidate. The agency said that it will require more time to review the NDA as the companies had recently submitted the Risk Evaluation and Mitigation Strategy (REMS) for the candidate. The REMS was submitted on Aug 26.
Ezogabine Backed by FDA Panel
Earlier this month, Glaxo and Valeant had received encouraging news in the form of 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 have failed.
The committee also reviewed the safety data on ezogabine. Questions had been raised regarding urinary retention, infection and kidney stones associated with the use of ezogabine. While most of the committee members voted in favor of patient monitoring for the reduction of the occurrence of urinary retention, the members voted unanimously that the same would not be needed for infection and kidney stones.
Ezogabine has been developed under a worldwide license and collaboration agreement between Glaxo and Valeant and FDA approval would be a major boost for both companies, especially Valeant.
According to estimates, more than 2 million people in the US have experienced an unprovoked seizure or been diagnosed with epilepsy. Although most of these episodes can be controlled with medicines, about 25% – 30% of people with epilepsy continue to experience seizures even after receiving treatment.
While currently available treatments include drugs like Pfizer’s (PFE) Neurontin and Lyrica, Glaxo’s Lamictal, UCB Pharma’s Keppra and Johnson & Johnson’s (JNJ) Topamax, ezogabine should be able to carve a niche for itself due to its differentiated mechanism of action.
Our Take
We currently have a Zacks #2 Rank (short-term Buy rating) on Valeant. We expect investor focus to remain on the proposed merger of Valeant and Biovail Corp (BVF) and the approval of ezogabine. A positive response from the FDA by Nov. 30 could lead to the product launch in the first quarter of 2011.
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