) 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
According to information provided by UCB, epilepsy affects
roughly 65 million people globally and 2.2 million people in the
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.
UCB carries a Zacks Rank #3 (Hold). Currently, companies like
Lannett Company, Inc.
SIGA Technologies, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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