Recently, Valeant Pharmaceuticals International (VRX) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for marketing approval for its drug candidate retigabine. Retigabine is a neuronal potassium channel opener indicated for treating adult epilepsy patients with partial-onset seizures.
 
Valeant has high hopes for its seizure drug, which is co-developed with GlaxoSmithKline PLC (GSK). The agreement pertains to the development and marketing of the drug in the U.S., Canada, Puerto Rico, Australia and New Zealand. Glaxo has exclusive rights pertaining to retigabine elsewhere.
 
Retigabine displayed encouraging results in late-stage studies reducing seizure rates compared to a placebo. The most common adverse effects are dizziness, fatigue, vertigo, tremor, abnormal coordination, diplopia, disturbance in attention, asthenia and blurring of vision. The thrice-a-day pill could get the FDA’s green light in 2011. However, it will face competition from leading players including Pfizer (PFE), UCB Pharma, GlaxoSmithKline, Johnson & Johnson (JNJ), Novartis (NVS) and Abbott Laboratories (ABT), and Cephalon (CEPH). FDA approval could result in an $8-million milestone payment for the Swedish specialty pharmaceutical company Meda AB , Valeant’s Retigabine partner.
 
In addition to the NDA acceptance by the U.S. agency, the drug is also under review in Europe. In November 2009, the European Medicines Agency (EMEA) accepted Valeant’s application to market the drug in Europe.
 
Valeant Pharmaceuticals was founded in 1960 and is headquartered in Aliso Viejo, California. The company engages in the development, manufacture, and marketing of a wide range of pharmaceutical products. It primarily offers specialty pharmaceutical and over-the-counter (OTC) products in the dermatological and neurological fields.
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