Drug Development, Licensing

Once a blockbuster-to-be, Teva finally sounds taps for its PhIII loser laquinimod

This was the year that the old management team at Teva once confidently predicted that its lead drug laquinimod would be approved for multiple sclerosis. Instead, it’s time for the new executive team at the company to finally sound taps for a drug that offered some intriguing signals of efficacy but failed one crucial primary endpoint after the next.

Helén Tuvesson

Active Biotech, the Swedish company that out-licensed the drug to Teva 14 years ago for clinical development, put out a note this morning that Teva had returned all rights to the drug, which flopped in multiple Phase III studies for progressive and relapsing/remitting MS as well as a mid-stage trial for Huntington’s disease. The last failure was recorded just a few weeks ago.

Laquinimod was written off by analysts long ago. It was picked up in 2004 to succeed Copaxone, hoping to protect a blockbuster franchise for a company known for both generic as well as branded drugs. 

Teva, though, chose wrong — which became painfully apparent around the same time their generics business was cratering, triggering a company-wide reorganization.

Active Biotech execs — who saw their battered stock $ACTI slide 7% this morning — plan to study the situation, holding up the drug’s success on a secondary endpoint as reason to continue to believe this drug is still worth pursuing in the clinic.

“The pronounced effect of laquinimod on brain atrophy demonstrated in both RRMS and HD patients supports our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases, a disease area where the medical need remains high. Therefore, we will assess all opportunities for a continuation of the development of laquinimod” said Helén Tuvesson, CEO of Active Biotech.


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