Just 16 months into its existence, a local biotech startup has investors swarming.
Gaithersburg, Md.-based Viela Bio has completed a $75 million Series B funding round, bringing its total raised since launching to more than $350 million.
The company plans to put the funding toward its Biologics License Application with the Food and Drug Administration for its lead product candidate, inebilizumab, as well as further research on other drugs.
Inebilizumab is a product for blood cancers and autoimmune diseases that is currently in clinical trials. It treats neuromyelitis optica spectrum disorder, an autoimmune disease that impacts the central nervous system. There are currently no approved treatments for NMOSD, which can lead to paralysis, blindness and respiratory failure.
"While our priority is to serve this patient population through the successful approval and launch of inebilizumab, we believe this financing also puts us in a strong position to pursue additional new indications with inebilizumab," CEO Bing Yao said in a statement.
The round was led by HBM Healthcare Investments and included Temasek, as well as several new investors: Goldman Sachs, Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners and Barer & Son Capital.
Securing the necessary FDA clearance would get the clinical-stage company’s first product to market. It could come about six months after the application is filed, and may be available to patients as soon as 2020.
So, how did it get here?
Viela isn't a traditional pharmaceutical startup. It spun out of MedImmune, a biotech company now owned by AstraZeneca, in February 2018 with $282 million from investors. That funding was led by 6 Dimensions Capital, Boyu Capital and Hillhouse Capital, and included Temasek and Sirona Capital. AstraZeneca remains the largest minority shareholder of the company, which is housed on MedImmune's campus.
Viela began its independent existence with three drug candidates in clinical trials – a milestone that usually takes startups years to reach. Yao, a Genentech alum and senior VP of research and development at MedImmune, was named CEO. Jorn Drappa, MedImmune VP of clinical development, joined as chief medical officer.
At the time, the spinoff company planned to wrap up clinical trials by late 2019 and start applying for federal approval for its lead candidate in 2020.
First, the FDA gave inebilizumab orphan status, which gets it an accelerated review as a treatment for a rare condition. Then, in April this year, the FDA granted breakthrough status to Viela for inebilizumab following a study it called “the largest monotherapy study ever conducted in NMOSD.”
The company reported a 77 percent reduction in the risk to patients compared to the placebo, and completed it faster than anticipated. The designation expedites drug development and regulatory review, and usually takes biotech companies years to achieve.
Then, in late May, Viela sealed a deal worth up to $220 million with Chinese company Hansoh Pharmaceutical Group to commercialize inebilizumab in China, setting the stage for international distribution once approved in both countries.
With the funding, studies and partnership in place, the company now plans to file a Biologics License Application with the U.S. government in coming months. If things go its way, it could earn FDA approval to commercialize the drug in six months and get it to patients by early next year.
