UCB (UCBJF) was in the news again recently after the US Food and Drug Administration (FDA) approved its lead product, Keppra (levetiracetam), for use as adjunctive therapy for the treatment of partial onset seizures in adults and children aged one month and older suffering from epilepsy. The approval is for the tablet and oral formulation of the drug.
We note that while Keppra is already available in the US as adjunctive therapy for the treatment of partial onset seizures in adults and children of four years of age and older with epilepsy, it is marketed in the European Union (EU) as adjunctive treatment of partial onset seizures in infants and young children aged one month to under four years.
We believe that the approval of Keppra for the extended patient population will help UCB book incremental sales from the drug. This news is also in line with the company’s focus to develop therapeutics for central nervous system (CNS) disorders.
Earlier during the month, UCB had restructured its agreement with Japanese partner Otsuka Pharmaceutical Co. regarding Keppra, Neupro (rotigotine) and Cimzia (certolizumab pegol). The companies decided to end their co-development and co-promotion agreement for Cimzia in Japan, after a mutually decided period, while they continued to work together for Keppra and Neupro. UCB and Otsuka Pharma have an agreement to co-promote Neupro and Keppra in Japan.
Otsuka Pharma markets Keppra as E Keppra in Japan for the adjunctive treatment of partial onset seizures in adults with epilepsy, which offers many patients a new option of treatment. Further, the company has filed for the approval of Neupro in Japan for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS).
Cimzia is currently marketed in the US and EU for the treatment of adults with moderate-to-severely active rheumatoid arthritis (RA). The drug is also marketed in the US for reducing signs and symptoms of Crohn’s disease (CD).
We currently have a Zacks #3 Rank (short-term Hold rating) on UCB.
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