UPDATE 1-Lundbeck says clobazam effective in seizures
* Phase 3 clobazam trial gets good results treating seizures
* Company repeats will file application with FDA by year-end
* Shares up 0.8 percent
(Adds detail, analyst, share price)
By John Acher
COPENHAGEN, Dec 6 (Reuters) – Danish drugmaker H Lundbeck (LUN.CO) said it got positive results in a Phase 3 trial of its candidate drug clobazam in treating seizures associated with Lennox-Gastaut syndrome.
Lennox-Gastaut syndrome (LGS) is is a rare and severe form of epilepsy and Lundbeck reiterated it expected to submit a new drug application for clobazam as an adjunctive treatment for LGS to the U.S. Food and Drug Administration by year-end.
Clobazam is part of Lundbeck’s efforts to develop new drugs to replace its antidepressant escitalopram — sold as Lexapro in the United States and Cipralex in other markets — once patents expire in 2012-2014.
Deutsche Bank said in a note to clients it expected clobazam to generate sales of $100 million by 2016 if it were approved by U.S. regulators in late 2011.
Deutsche Bank analysts, who have a “buy” rating on the stock, noted clobazam represented a “shortlived but meaningful opportunity for Lundbeck to diversify” ahead of patent expiries. “Given that few analysts give Lundbeck credit in their models for the drug, we believe this offers about 10 percent potential upgrade to 2016 consensus EBIT forecasts if approved,” they said.
The clinical test of efficacy and safety found 77.6 percent of patients who received high-dosage clobazam achieved a 50 percent or greater reduction in the average weekly rate of seizures, Lundbeck said in a statement.
The two highest dosages of clobazam as an add-on therapy achieved the main objective of the study, which was a statistically significant reduction in the average weekly rate of seizures, compared with placebo, Lundbeck said.
The data from the study were presented at the American Epilepsy Society meeting in San Antonio, Texas, it said.
“While several medications are approved in the United States for treatment of LGS, many patients continue to have seizures due to the intractable nature of the disease,” Joan Conry, professor of neurology and a principal investigator in the study, said in the statement. Clobazam is marketed outside of the United States in more than 100 countries under various brand names, including Frisium or Urbanyl, Lundbeck said.
Shares in Lundbeck traded up 0.8 percent at 102.90 crowns by 1212 GMT, outperforming the STOXX Europe 600 healthcare sector index .SXDP which was down 0.2 percent. (Editing by Jon Loades-Carter and David Holmes)