- The Food and Drug Administration has approved a new drug to treat a rare autoimmune disease that can cause blindness and paralysis, capping a two-year span in which the medicine's developer, Maryland-based Viela Bio, went from big pharma spinout to commercial-stage company.
- Approved Thursday as Uplizna, Viela's drug will launch later this month and compete with existing therapies from Roche and Alexion Pharmaceuticals. The condition Uplizna treats, neuromyelitis optica spectrum disorder, or NMOSD, affects 10,000 people in the U.S.
- Since physicians already have experience treating NMOSD with Roche's Rituxan and its biosimilars, Uplizna isn't likely to become first-line therapy, Stifel analyst Derek Archila wrote in a note to clients. Viela shares fell 8% in Friday morning trading.
Viela came to life because of AstraZeneca CEO Pascal Soriot's strategy of selling off lower priority research and development projects like Uplinza.
The biotech launched in February 2018 with $250 million in venture capital funding. By October 2019, Viela debuted as a public company with a $173 million stock offering.
Uplizna won approval in NMOSD on the basis of a clinical trial called N-MOmentum. The study enrolled patients who test positive for an antibody present in 80% of NMOSD patients. Participants who took Viela's drug were 77% less likely to relapse during more than six months of follow-up than those who took placebo.
Alexion's Soliris, which has is approved to treat the condition, reduced the risk of relapse by 94% over one-year of follow-up. Roche's Rituxan has never gained been cleared by the FDA for NMOSD, so its use is considered off-label. A recent retrospective study of Rituxan indicated that patients on first-line immunosuppressants were nearly three times as likely to relapse when compared to Rituxan.
Roche is also developing a new treatment for NMOSD called satralizumab.
In NMOSD, a relapse involves inflammation of the optic nerve, spinal cord or a region of the brain, causing nausea and vomiting.
Pricing is likely to be a chief concern as Uplizna launches. In NMOSD, use of Rituxan or biosimilars like Teva's Truxima costs $33,000 to $37,000 a year, Stifel's Archila wrote. Soliris, meanwhile, is a famously expensive drug that costs more than $700,000 a year for NMOSD.
In an email, a Viela spokesperson said the company has not disclosed Uplizna's price.
Archila, who initiated coverage on Viela earlier this week with a "hold" rating, said he is anticipating a net price of around $175,000 a year.
"The challenge for [Viela] will be proving inebilizumab's differentiation from rituximab on efficacy, and more importantly, safety where physicians have had years of experience with rituximab," Archila wrote, using the generic names for Uplinza and Rituxan.
Insurers will likely reserve reimbursement for Uplizna patients who relapse on Rituxan, he added. Archila therefore believes most Wall Street estimates of Uplizna sales are too high.
Viela is also testing Uplizna in myasthenia gravis and kidney transplant patients, and has two other clinical-stage candidates to treat autoimmune diseases.