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Posted by on Aug 2, 2011 in FDA, Neurology, Neuropsychiatry, Pharma

Teva’s MS Pill Fails to Meet Primary Endpoint; Shares Fall

Teva’s MS Pill Fails to Meet Primary Endpoint; Shares Fall

Laquinimod, Teva’s investigational pill for multiple sclerosis, was no better than placebo for reducing relapses in a 2-year phase 3 study (BRAVO) of patients with relapsing-remitting disease. These initial trial results were provided yesterday by Teva in a press release, which also reported that laquinimod-treated patients had a greater burden of disease at baseline, as demonstrated by MR images. When this “imbalance” was corrected, hedged the company, significant reductions in the annualized relapse rate, disability progression, and loss of brain volume were realized.*

But no matter. Company share value dropped precipitously on the news, from about $46.50 to less than $42.50 (~9%), as of this post.

Teva_laquinimod_news.pngAnd despite this dismal outcome for the maker of Copaxone (the number-1-selling and most expensive self-injected MS drug in the world), Tevas says that it still plans to submit laquininod for FDA approval at some unspecified time. Claimed Teva’s Group VP of Global Branded Products, Yitzhak Peterburg, somewhat disingenuously but expectedly, “We are encouraged by the overall outcomes achieved in the laquinimod Phase III clinical development program…Teva remains committed to the clinical development of laquinimod and is confident that the drug could provide a unique option for the treatment of multiple sclerosis.”

Unlike fingolimod (Gilenya; Novartis), the only FDA-approved disease-modifying pill for the treatment of MS, laquinimod appears to exert its anti-inflammatory effects less specifically, through a variety of possible mechanisms. Maybe that fact has something to do with the phase 3 outcome. Who knows?

Other possible oral options for MS in late-phase development include teriflunomide (sanofi-aventis) and BG-12 (dimethyl fumarate; Biogen Idec). In June, Merck KGaA announced that it would cease development of its oral contender, cladribine.

* A separate arm evaluated once-weekly IM interferon beta (Avonex); however, the study was not powered to compare laquinimod with the injectable disease-modifying agent.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.