With Japan submission nearing in NMOSD, Viela picks Mitsubishi as territorial partner

Just days after completing its IPO, Viela will receive another cash infusion from a partnership giving Mitsubishi Tanabe territorial rights to lead program inebilizumab to treat neuromyelitis optical spectrum disorder.

Viela Bio Inc. (NASDAQ:VIE) will receive $30 million up front and is eligible for undisclosed milestones, plus additional payments it described as “based, in part, on sales revenue.” The cash adds to a balance sheet that had about $189 million at June 30, and was augmented by $172.6 million in gross proceeds from Viela’s IPO, including its underwriters’ exercise of their overallotment option.

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) will receive local rights to inebilizumab, a mAb targeting CD19, as it nears registration in Japan for NMOSD. Viela spokesperson Amy Bonanno told BioCentury the partners expect a submission to Japanese regulators next year, and do not expect to conduct additional trials before then. A BLA is under FDA review; its PDUFA date is June 11, 2020 (see "Viela Planning Submission").

Mitsubishi Tanabe’s pipeline includes a handful of other candidates for CNS disorders, including amyotrophic lateral sclerosis, Parkinson’s disease, tardive dyskinesia and schizophrenia. The Japanese pharma will hold inebilizumab’s rights in Japan as well as in Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

Inebilizumab would likely be at least second to market in Japan for NMOSD. Soliris eculizumab, a C5 inhibitor from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), is under review by Japan’s Ministry of Health, Labour and Welfare (MHLW); spokesperson Megan Goulart told BioCentury that Alexion expects a decision by YE19. FDA and the European Commission approved the drug this year for NMOSD. It has Orphan Drug designation in all three geographies for the indication.

Satralizumab, an inhibitor of CD126 from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), received Orphan Drug designation from MHLW last month. Chugai said at the time that it was preparing regulatory submissions, but did not say in which territories. The company, majority owned by Roche (SIX:ROG; OTCQX:RHHBY), did not respond to inquiries on Wednesday (see "Chugai's mAb Meets in Phase III").

Viela has estimated that there are about 5,000 patients with NMOSD in Japan, as of 2017. The disease affects the optic nerve, spinal cord and brain stem, and can lead to paralysis and blindness.

Viela is planning three other studies of inebilizumab by next year. This quarter, it intends to start a Phase II study of the mAb for kidney transplant desensitization. Next year, it plans to start a pivotal trial in myasthenia gravis and a Phase IIb study for IgG4-related disease.

The company is anticipating further progress on two other clinical candidates: VIB4920, which is an anti-CD40L-Tn3 fusion protein engineered without an Fc region; and VIB7734, a mAb against LILRA4.

By year end, it intends to begin separate Phase II studies of VIB4920 for Sjogren’s syndrome and kidney transplant rejection. Interim data for VIB7734 are due next half from cohorts with cutaneous lupus erythematosis in a Phase Ib trial.

Viela lost $1.94 to $19.11 Wednesday. Its shares dipped briefly below their IPO price of $19, bottoming out at $18.20 intraday; Viela has traded as high as $25.50 since trading began Oct. 3 (see “Three Biotechs Price IPOs”).

Targets: C5 - Complement 5; CD40L (CD40LG; CD154) - CD40 ligand; CD126 - Interleukin-6 receptor; LILRA4 (ILT7) - Leukocyte immunoglobulin-like receptor subfamily A (with TM domain) member 4

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