UCB S.A. (UCBJF) announced that its investigational antiepileptic candidate, brivaracetam, has been accepted for review in the U.S. and the EU. The company is looking to get the candidate approved as an adjunctive therapy for the treatment of partial-onset seizures in epileptic patients aged 16 years and above.
With the acceptance of brivaracetam for review by the FDA and the European Medicines Agency, UCB has crossed two major milestones. As one of its epilepsy drugs, Keppra, is facing generic competition, a positive response from the regulatory bodies should help company replace lost revenues.
According to the press release issued by UCB, epilepsy is the fourth most common neurological disorder in the U.S. Approximately 1 in every 26 people is expected to suffer from epilepsy in their lifetime. Given that almost 65 million people across the world suffer from the disease, among which more than 2 million patients belong to the U.S., we believe that the candidate has a vast market opportunity upon potential approval.
Meanwhile, UCB is looking to gain approval for its epilepsy drug, Vimpat, in additional countries. UCB intends to file for Vimpat in Japan and China as adjunctive therapy for the treatment of epilepsy patients with partial-onset seizures in 2015.
We are encouraged by the acceptance of brivaracetam for review in the U.S. and the EU and expect investor focus to remain on regulatory updates from the company.
UCB carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Amgen Inc. (AMGN), BioCryst Pharmaceuticals, Inc. (BCRX) and Biodel Inc. (BIOD). All these stocks carry a Zacks Rank #1 (Strong Buy).
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