Biotech Values

[DewDiligence]

TEVA/ACTI.ST—High dose of Laquinimod dropped from two MS studies after safety imbalance:

http://finance.yahoo.com/news/teva-active-biotech-announce-discontinuation-140000337.html

Teva Pharmaceutical Industries Ltd. and Active Biotech (NASDAQ Stockholm:ACTI) today announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.

…The DMC identified an imbalance in the number of cardiovascular events in the studies. Seven events were observed in patients receiving laquinimod daily at 1.2mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. No events occurred in the 0.6mg or placebo groups… One event was observed in the 1.5mg daily-dose arm of the ARPEGGIO trial in primary-progressive MS (PPMS).

…Both trials, CONCERTO and ARPEGGIO, are continuing the lower-dose arms (0.6mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. The DMC did not identify a cardiovascular signal with the lower dose but recommended long-term monitoring.

It’s astonishing that Laquinimod is still around after so many years of disappointment.