Biotech General Discussion

#TGTX today reported out impressive topline data today for its ULTIMATE I and II trials comparing its investigational glycoengineered anti-CD20 biological called #ubliximab (#UBLI) to teriflunomide in subjects with relapsing forms of multiple sclerosis. The data met the primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide. Detailed data on secondary endpoints and safety will be presented at a scientific conference in the first half of 2021.

Ublitimab's <0.1 ARR looks better than the registrational data for Genentech's infused anti-CD20 blockbuster, OCRE, and likely similar to Novartis's approved subcutaneous anti-CD20, Kesimpta. For OCRE the ARR data in years 1 and 2 of its registrational trials were 0.156 and 0.155, respectively. (See package insert here) compared to the control arm, REBIF's, 0.292 and 0.290, respectively. For Genentech's subcutaneously administered anti-CD20 Kesimpta, the ARR was 0.11 and 0.10, in their 2 registrational trials (See package insert here) vs. 0.22 and 0.25 for teriflunomide (a 51% and 59% reduction in the 2 studies). Of course, cross-trial comparisons need to be taken with caution.

At this point it now looks like when not if UBLI will come to the market. The question will be how well it fares against the established OCRE, which requires a longer (4 hour) infusion, and Kesimpta, which is a self-administered subQ injection at home. TGTX reiterated that it planned to compete on price with one analyst on today's call mentioning a 20% reduced price point.

Check out our AmpCard on Ublitux for MS here.

Amp Team (Manny 12/10/20)

For Ocrevus, also see ocrevus.com and also see:

1) Hauser SL, Brochet B, Montalban X, et al. Long-term reduction of relapse rate and confirmed disability progression after 5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-12, 2018; Berlin, Germany. 2) OCREVUS [prescribing information]. South San Francisco, CA: Genentech, Inc. 2020. 3) Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221-234. 4) Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3)(suppl):S6.

For Kesimpta, also see Package insert and Kesimpta.com.

#multiple_sclerosis, #OCRE, #Kesimpta, #antiCD20, #biologic