UCB (UCBJY) recently received good news with the company announcing positive results on Vimpat (lacosamide) from a phase III study being conducted to support the label expansion of the drug.
The double-blind, randomized, historical-controlled study evaluated Vimpat (400mg/day) for conversion to monotherapy in patients with partial-onset seizures taking one to two other anti-epileptic drugs (AEDs). The study met its primary endpoint by demonstrating a significantly lower exit rate for patients on Vimpat than the historical control.
UCB intends to submit a supplemental New Drug Application (:NDA) to the US Food & Drug Administration (:FDA) in the second half of 2013.
According to information provided by UCB, epilepsy affects roughly 65 million people globally and 2.2 million people in the US.
We note that Vimpat revenues for 2012 were €334 million, reflecting an increase of 44%.
In May 2009, Vimpat was launched in the US as an add-on therapy for the treatment of partial-onset seizures in people (more than 17 years) with epilepsy.
Vimpat was first launched in the EU in Sep 2008 as an adjunctive therapy for treating adults and adolescents (16-18 years) suffering from partial-onset seizures (with or without secondary generalization) with epilepsy.
In Feb 2013, UCB received EU approval for Vimpat as a single loading dose option for treating patients suffering from partial onset seizures. Vimpat will be used for initiation as a single loading dose (200 mg). This will be followed by a 100 mg twice daily Vimpat maintenance dose regimen 12 hours later.
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