Inebilizumab will be developed and marketed in the Asian regions for the treatment of neuromyelitis optica spectrum disorder (NMOSD), and also other potential indications in the future.
As per the terms of the deal, the US-based Viela will be paid upfront a licensing fee of $30m. The company also stands to gain additional payments based on certain development and commercial milestones along with payments based, in part, on sales revenue.
Viela executive chairman and CEO Bing Yao said: “This partnership adds to our ability to commercialize inebilizumab globally, subject to regulatory approval.
“As a well-established pharmaceutical company in Japan, Mitsubishi Tanabe has strong product development and commercialization capabilities in Asia, and we believe, is an ideal partner for expanding inebilizumab’s potential reach to thousands of additional patients in need of viable treatments, with NMOSD as an initial indication.”
Mitsubishi Tanabe will handle the development and commercialisation of inebilizumab in Japan, Thailand, South Korea, Indonesia, Vietnam, Singapore, Malaysia, Philippines, and Taiwan.
Mitsubishi Tanabe president and representative director Masayuki Mitsuka said: “Inebilizumab is an exciting product candidate that, based on the results from the N-MOmentum pivotal study, is well-positioned to provide meaningful benefit for patients with NMOSD, and potentially additional diseases, subject to regulatory approval.
“We are excited to work with Viela to advance inebilizumab in Japan and other Asia regions, and look forward to a productive partnership between our companies.”
Inebilizumab is a humanized monoclonal antibody, which has been designed to bind to CD19 with high affinity. CD19 is a protein that is expressed on a large variety of B cells, which includes plasma cells and antibody-secreting plasmablasts.
Upon its binding to CD19, the B cells get quickly depleted from circulation.
Recently, Viela’s biologics license application (BLA) for the humanised monoclonal antibody for the treatment of NMOSD has been accepted for review by the US Food and Drug Administration (FDA).
In April 2019, the drug secured breakthrough therapy designation (BTD) from the regulator for the treatment of NMOSD, which is considered to be a rare, life-threatening autoimmune disease that impacts the central nervous system.