September 15, 2008 / 9:09 AM / 11 years ago

UPDATE 1-UCB says Keppra XR epilepsy drug approved in U.S.

(Adds share price, analyst comment)

BRUSSELS, Sept 15 (Reuters) - Belgian pharma group UCB (UCB.BR) said on Monday that U.S. health authorities had approved epilepsy drug Keppra XR and that it would go on sale just before its mother drug loses patent protection.

UCB said Keppra XR, the once-daily extended release tablet version of its blockbuster Keppra, had been cleared as an add-on treatment for partial onset seizures of people aged 16 years or older.

The company expects it to be available in U.S. pharmacies at the end of September. UCB hopes that it will win over epilepsy patients who typically take drugs at least twice a day.

Keppra, with sales last year of 1.03 billion euros ($1.44 billion), will lose U.S. patent protection at the end of this year and is expected to face competition from generics there from November. Its patent protection lasts until 2010 in Europe.

Keppra XR has U.S. patent protection until the end of 2011.

Rabo Securities said in a morning note that it was expecting Keppra XR to be approved, but only in 2009. It added it had been looking to peak sales of the drug in 2011 of 300 million euros.

It raised its price target to 19 from 18 euros, while maintaining a reduce rating.

Bank Degroof raised its price target to 35 from 34 euros.

Other brokers said the news was a slight positive, but that Keppra XR would probably only provide limited protection of product sales from generic erosion and saw peak sales of 150 to 200 million euros.

UCB faces a number of likely decisions from the U.S. Food and Drug Administration on key drugs in the next few months.

These include Vimpat for epilepsy following its earlier rejection for diabetic neuropathic pain, Neupro for restless legs syndrome and advanced Parkinson’s disease and Cimzia for rheumatoid arthritis. (Reporting by Philip Blenkinsop; editing by Rory Channing)

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