Novartis presents weaker-than-expected relapse data for multiple sclerosis drug remibrutinib

By Bhanvi Satija and Marleen Kaesebier

LONDON/ZURICH, Oct 23 (Reuters) - Swiss drugmaker Novartis' NOVN.S oral multiple sclerosis (MS) drug remibrutinib meaningfully reduced relapses in patients, according to data presented at a medical conference in Toronto on Friday, but less than analysts had expected.

The drug reduced annualized relapse rates by 35.2% and 31.2%, compared with teriflunomide, an older MS treatment sold by Sanofi under the brand name Aubagio. Analysts had expected a reduction of 45% to 60%.

The detailed trial results, previously disclosed only in top-line form, were presented days after Roche ROPC.S released its own data on rival MS drug fenebrutinib. In pooled Phase III data, Roche reported a 55% reduction in annualized relapse rate versus teriflunomide.

"All in all, they might be quite similar in what they do in terms of reducing relapses and disability," Heinz Wiendl, co-chair of the Novartis studies, said in an interview.

Ahead of the readout, analysts said that relapse improvements similar to those seen in Roche's trial would be needed to show that this class of treatments is better than the currently used anti-CD20 therapies. These include Ocrevus, Novartis' Kesimpta and TG Therapeutics' TGTX.O Briumvi, which target and kill the immune cells that drive MS.

Novartis is banking on the success of the drug across different therapeutic areas, especially following a string of recent trial setbacks for its heart drug pelacarsen and muscle weakness therapy del-desiran.

Analysts currently estimate remibrutinib could bring in over $4 billion in peak sales, if approved for patients with relapsing forms of MS.

The two competing MS drugs belong to a class of treatments previously linked to liver toxicity, making safety a closely watched concern.

While Roche's fenebrutinib could have an edge in terms of efficacy, it showed significantly higher liver enzyme elevations versus the comparator drug. Novartis said there was no liver safety signal in its drug.