Replies to post #124206 on Biotech Values

[jq1234]

By contrast, a third group of patients who got Avonex, an older injected treatment from Biogen Idec Inc. (BIIB), had fewer relapses than those who got a placebo in the study.

“Laquinimod is dead, if not regulatorily, then commercially,” said Ori Hershkovitz, a partner at Sphera Funds Management Ltd. in Tel Aviv.

http://www.bloomberg.com/news/2011-08-01/teva-s-oral-multiple-sclerosis-drug-fails-to-meet-goal-of-clinical-trial.html

[floblu14]

Teva, Active Biotech Multiple Sclerosis Treatment Misses Primary Goal
DOW JONES NEWSWIRES

Teva Pharmaceutical Industries Ltd. (TEVA)said their investigational oral treatment for a relapsing form of multiple
sclerosis added to data demonstrating significant reduction in brain-volume loss and the risk of disability progression.

However, the once-daily treatment--called laquinimod-- failed to meet its primary endpoint of reducing relapses when compared with a placebo in a Phase III study. Still, following a standard adjustment in a predefined sensitivity analysis, the treatment significantly reduced the annualized relapse rate.

The companies plan to submit the treatment for regulatory approval in the U.S. and European Union. Teva acquired in 2004 the exclusive global rights to develop and commercialize laquinimod with the exception of in the Nordic and Baltic countries, where Active Biotech retained the rights, according to Teva's website.

Teva's American depositary shares closed Friday at $46.64 and were halted premarket.

http://online.wsj.com/article/BT-CO-20110801-706781.html

[pcrutch]

I suspect this raises the prospects of TEVA attempting to settle their litigation over Copaxone.

[biomaven0]

If the randomization was “properly performed” and baseline MRI status was a pre-specified variable of interest, why weren’t the trial arms stratified with respect to this variable?

I'm assuming they didn't stratify with respect to all possible variables.

It's worth noting that Avonex also didn't beat placebo in the non-adjusted comparison, but did so after adjustment.

The interesting play here might be the Swedish company Active Biotech (NASDAQ OMX NORDIC: ACTI) which was down very sharply indeed.

Peter