With EU knockback laquinimod’s irrelevance is all but assured

Considering Teva’s boardroom shakeup and the imminent genericisation of its blockbuster Copaxone, the group and its investors probably have bigger problems to worry about than last week’s EU rejection of the multiple sclerosis project laquinimod.

Not so laquinimod’s originator, Active Biotech, whose stock crashed 46% on Friday. Notwithstanding the companies’ glib commitment to continue laquinimod’s development the harsh reality is that, even if the project ever reaches the market, it will by that time largely be an irrelevance.

Admittedly, EU approval was not a fait accompli, and previously aired problems with the quality of laquinimod’s data were cited as one reason for the CHMP’s negative opinion (Fortified with sentiment and cash, Active Biotech presses on, March 8, 2013). But it got worse.

The CHMP also pointed to animal data suggesting an increase in cancer incidence after long-term exposure to laquinimod (Nerventra), and effects on the unborn baby. Moreover, the committee said it was unconvinced about proposed measures to prevent pregnancies in prospective female patients.

Some analysts had already expressed doubts about the strength of laquinimod’s dataset, which included pooled results of the phase III Allegro and Bravo studies. The former did yield positive data but fell short of expectations, while the latter failed outright, although Teva presented a correction based on which it claimed a positive outcome.

The CHMP said laquinimod’s effect on reducing relapses – the primary endpoint in both studies – was modest.

Before Friday’s crash Active had been one of the better-performing EU stocks of the past two years, but it is difficult to see a clear way forward for it now. Its only other late-stage asset is tasquinimod, but this is going after another highly competitive and fast-changing space – prostate cancer.

Mired in delays

EU approval was seen as a glimmer of hope for laquinimod, a project that is mired in delays in the US as well, and whose role had already been reduced to that of a bit player in a market set to be dominated by Biogen Idec’s Tecfidera, which has made a strong start towards becoming a major blockbuster.

All the more puzzling why Active and Teva immediately reaffirmed their continued commitment to laquinimod’s development. They said they would request a re-examination of the CHMP opinion, and also hinted at the project’s potential in other indications, including Crohn’s and Huntington’s diseases.

In the US a filing will not be submitted before results from Concerto, a third phase III study, in 1,800 MS patients, are generated in 2016 at the earliest. Teva recently began a fourth study, Libretto, pitting laquinimod head-to-head against Biogen Idex’s Avonex in 600 patients.

At least for now Active can rely on the support provided by Teva, which given its own problems probably sees little value in pulling the plug on a project in which it has already invested significant amounts of cash. But the development effort is fast beginning to look like throwing good money after bad.

To contact the writer of this story email Jacob Plieth in London at[email protected]or follow@JacobEPVantageon Twitter

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