UCB (UCBJF) recently announced that the US Food and Drug Administration (FDA) has approved Neupro (rotigotine) to treat signs and symptoms of advanced stage idiopathic Parkinson’s disease (PD) and moderate-to-severe primary restless legs syndrome (RLS).
We note that Neupro is currently approved in the US and the European Union (EU) for the treatment of the signs and symptoms of early-stage idiopathic PD. The drug is also approved in the EU for the symptomatic treatment of moderate to severe idiopathic RLS in adults.
It has been a positive year so far for UCB. In January, the 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 EU as adjunctive treatment of partial onset seizures in infants and young children aged one month to under four years.
We currently have a Zacks #3 Rank (short-term Hold rating) on UCB. We believe that the approval of Neupro in the US will add to the company’s top line, which increased 6.0% in 2011 to $4,525.9 million, driven by strong sales of Cimzia (up 63%), Vimpat (up 70%), Neupro (up 16%) and Keppra (up 3%). Moreover, we expect UCB to continue posting strong results riding on the sales of these drugs.