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LONDON, Sept 1 (Reuters) - Swiss drugmaker Novartis said on Tuesday its oral drug remibrutinib outperformed an older treatment in reducing relapses in patients with a form of multiple sclerosis, boosting hopes the medicine could become a blockbuster product.
The trial results mark the first success from three closely watched Novartis pipeline programmes due to deliver data this year. Investors are focused on remibrutinib, heart drug pelacarsen and gene therapy del-desiran, which together are seen generating more than $10 billion in peak annual sales and underpinning the company's long-term growth.
Novartis is seeking to replenish its drug pipeline as it faces revenue pressure from generic competition to blockbuster heart-failure drug Entresto.
- Remibrutinib outperformed teriflunomide in 2 late-stage MS trials.
- Reduced relapses; also slowed disability progression vs teriflunomide.
- Well tolerated; no liver safety issues reported.
- BTK inhibitor class has prior liver-toxicity concerns; class safety still under review.
- FDA previously rejected tolebrutinib for lacking relapse superiority vs Aubagio.
Shares of the company rose 4% on Tuesday as investors looked past safety updates related to its CAR-T therapy studies following the death of three patients. The stock is up 17% so far this year.
"Overall, remi looks like it is at least a best-in-class oral agent," UBS analyst Matt Weston wrote in a note.
He said the combination of strong relapse prevention and an improved liver safety profile made choosing remibrutinib over rivals "a no-brainer".
The two late-stage trials, REMODEL-1 and REMODEL-2, compared remibrutinib with teriflunomide in adult patients. Teriflunomide is sold by Sanofi under the brand name Aubagio.
In the trials, remibrutinib also delivered clinically meaningful results in slowing disability progression compared with teriflunomide.
Novartis said remibrutinib was well tolerated and showed no liver safety issues, consistent with previous studies.
The company plans to seek regulatory approvals globally and will present full trial data at a medical conference in Toronto.
Remibrutinib is already approved for a chronic inflammatory skin condition that causes severe hives and is sold under the brand name Rhapsido. The drug generated $64 million in second-quarter sales.
Novartis is also testing remibrutinib for another skin disease and food allergies. Analysts say the drug could generate as much as $9 billion in peak annual sales across all indications if development is successful.
CLASS-WIDE SAFETY RISKS
Analysts said the results also help address safety concerns that have weighed on other drugs in the same class, though they noted two patients died during the studies.
While the deaths were not related to treatment, analysts said they would be looking for more detailed safety data.
Remibrutinib belongs to the Bruton's tyrosine kinase (BTK) inhibitor class, which works by blocking inflammatory immune cells.
Earlier drugs in the class have faced regulatory setbacks over liver toxicity. In December, the U.S. Food and Drug Administration declined to approve Sanofi's tolebrutinib to slow disability progression after the drug failed to show superiority to Aubagio in preventing relapses.
Roche's fenebrutinib has also faced questions over its safety profile, dampening expectations for its eventual approval.
About 1.8 million people worldwide are estimated to have multiple sclerosis, according to the latest World Health Organization data.
(Reporting by Bhanvi Satija. Editing by Louise Heavens and Mark Potter)
