Launch of Lundbeck's Cipralex delayed?

Danish pharmaceutical company H Lundbeck has said that it plans tolaunch its new-generation antidepressant Cipralex (escitalopram) in the first half of next year and not, as stated earlier, by the end of 2001. The company said that the Swedish drug regulatory authority has asked some follow-up questions regarding the registration dossier, but did not divulge further details.

Cipralex is a single-isomer version of Celexa (citalopram), Lundbeck's best-selling drug which is marketed in the USA by Forest Laboratories. Forest also has US rights to the new version, which offers a more rapid onset of action and improved tolerability, and filed for approval there earlier this year. Lundbeck submitted its dossier in January to the authorities in Sweden, which has been selected as the rapporteur country for the European Union mutual recognition process (Marketletter February 2).

Lundbeck said that no financial impact of the delay was expected this year, and reiterated its forecast that revenues would rise 35%, with operating profits up 80% for the year.