AstraZeneca spinout Viela Bio and China’s Hansoh Pharmaceutical Group have struck a deal to develop and market the former’s autoimmune drug inebilizumab in China. Viela will pick up the usual upfront fee and development, regulatory and commercial milestones, all of which could exceed $220 million.
Under the deal, Hansoh will lead development and commercialization for inebilizumab in China for neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease that has no approved treatment. People with NMOSD suffer attacks during which the immune system attacks the optic nerves, spinal cord and brain. These attacks can lead to paralysis and blindness. Current treatments such as immunosuppressants and steroids are used off-label to treat or prevent attacks. None of them have been “studied in a rigorous fashion in NMOSD,” said Viela Bio Chief Medical Officer Jorn Drappa in a previous interview.
Hansoh could also develop inebilizumab, a CD19-targeting antibody, for other inflammatory or autoimmune diseases and blood cancers, the partners said in a statement.
“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” said Viela CEO Bing Yao, Ph.D., in the statement. “Their significant commercial, regulatory and clinical development infrastructure gives us a strong strategic partner in China and also may provide support for our global product expansion and lifecycle plans.”
The partnership comes three weeks after Viela posted positive pivotal data for inebilizumab in NMOSD. The study enrolled 231 patients with varying severities of disease, including patients with and without autoantibodies against a protein called aquaporin-4 (AQP4). AQP4 antibodies are a biomarker of NMOSD and are believed to trigger NMOSD attacks when they bind to the nervous system.
The study showed that after six months of treatment, inebilizumab reduced the risk of attacks by 73% in all patients. Patients with AQP4 antibodies fared a little better: Their risk of attacks dropped by 77%. What’s more, 89% of patients in this group had no attacks during the six-month period compared to 58% of the patients on placebo.
Inebilizumab is given twice a year through an intravenous infusion that takes 90 minutes. After the six months, patients could sign up for an extension period during which they will receive additional doses of the drug every six months. Viela Bio aims to submit inebilizumab for FDA approval later this year. But inebilizumab isn’t alone in the race to market for NMOSD: It is chasing Alexion’s anti-complement C5 drug Soliris (eculizumab) and Chugai’s IL-6-targeting antibody satralizumab.