- TG Therapeutics on Monday said its experimental drug ublituximab reduced the annual relapse rate in multiple sclerosis patients by up to 60% more than Sanofi's Aubagio in Phase 3 clinical trials. The company expects to submit ublituximab — already under review by the Food and Drug Administration in a type of leukemia — for use in MS by September.
- The New York-based biotech claims its drug can compete with Roche's fast-selling medicine Ocrevus on effectiveness while offering better convenience due to a shorter infusion time for treatment than the Swiss company's drug.
- If approved, ublituximab would become the third MS drug cleared that works by targeting a protein found on B cells, after Ocrevus and Novartis' Kesimpta. Those two drugs have added to a wide range of options that include oral drugs like Biogen's Tecfidera and Novartis' Gilenya as well as older biologic medicines.
Challenging top MS drugmakers like Biogen, Roche and Novartis will take strong trial results and, possibly, a pharmaceutical partner to help on marketing. The data outlined Saturday at the American Association of Neurology annual meeting could help that cause, with data showing ublitixumab to be superior to Aubagio and potentially matching Ocrevus.
In December, TG announced the so-called ULTIMATE I and II trials of ublituximab in relapsing MS had met their primary goal, a disclosure that drove the company's share price up 41% in a single day. Saturday's presentation provided a detailed view of the data: against Aubagio, a pill, treatment with ublituximab led to a 60% lower annual rate of MS relapses in ULTIMATE I and 49% lower in ULTIMATE II.
Those relapse findings were accompanied by data indicating ublituximab reduced symptomatic brain lesions by 97% and 96% lower than Aubagio in ULTIMATE I and II, respectively. Other data showed a greater share of patients on TG's drug had no evidence of disease activity, although the difference in percentage with confirmed disability progression at 12 or 24 weeks was not statistically significant. Rates for either drug at those time points were low.
In clinical practice, ublituximab is likely to be compared more to Ocrevus and Kesimpta because they treat MS in the same fashion. All three bind to a protein on B cells — a type of immune cell — disabling them and tamping down the autoimmune process that leads to nerve cell destruction.
On that count, ublitixumab looks like it might have a chance to compete, as its annual relapse rate of 0.076 in ULTIMATE I and 0.091 in ULTIMATE II is on a par with the 0.156 and 0.155 found in Ocrevus' Phase 3 trials — although until the two are tested head-to-head, it is impossible to draw firm conclusions.
Still, Ocrevus has fast become a widely used treatment. Sales of Roche's drug, which is prescribed for both the relapsing form of MS and the more serious primary progressive MS, totaled 4.3 billion Swiss francs, or roughly $4.7 billion, in 2020.
Kesimpta, meanwhile, was approved in 2020. Novartis initially offered the drug free of charge, and so didn't report any sales.
Alethia Young, an analyst at Cantor Fitzgerald, forecast in an April 18 note to clients that ublituximab sales could reach $3 billion in 2026, assuming the drug launches next year. Her estimate was based on both the relative effectiveness of ublituximab along with an infusion time of one hour once patients enter the maintenance phase of dosing, compared with the two hours required by Ocrevus.
At Monday's share price of about $43, TG has a market capitalization of $6 billion.
Ublituximab is already under FDA review, in combination with TG's marketed cancer drug Ukoniq, in leukemia.