Bing Yao. Viela Bio

As­traZeneca spin­out Viela Bio pock­ets $75M on its way to BLA for au­toim­mune drug

On the verge of a BLA fil­ing for its lead drug in a pipeline spun out of As­traZeneca, Viela Bio has pushed its ven­ture fund­ing over the $300 mil­lion line.

The $75 mil­lion Se­ries B comes over a year af­ter the phar­ma gi­ant’s Med­Im­mune sub­sidiary pack­aged six drugs from its res­pi­ra­to­ry, in­flam­ma­tion & au­toim­mune unit in­to a $250 mil­lion biotech play­er. Bing Yao, who head­ed that team, is lead­ing Viela Bio as CEO.

With the new cash, the team — lo­cat­ed at Med­Im­mune’s base of Gaithers­burg, MD — ex­pects to get inebi­lizum­ab to the FDA soon, Yao said. The drug, which binds to CD19, is be­ing prepped to treat neu­romyelitis op­ti­ca spec­trum dis­or­der, or NMOSD, an au­toim­mune dis­ease marked by in­flam­ma­tion of the op­tic nerve and spinal cord.

A Phase IIb piv­otal tri­al showed that pa­tients re­ceiv­ing the ther­a­py ex­pe­ri­enced a 77% de­crease in the risk of de­vel­op­ing an NMOSD at­tack ver­sus place­bo.

While se­cur­ing an ap­proval for this in­di­ca­tion will be the pri­or­i­ty, “we be­lieve this fi­nanc­ing al­so puts us in a strong po­si­tion to pur­sue ad­di­tion­al new in­di­ca­tions with inebi­lizum­ab,” Yao added.

Op­er­at­ing un­der a biotech struc­ture while work­ing with old col­leagues from Med­Im­mune and get­ting sup­port — in terms of fi­nances as well as man­u­fac­tur­ing — from As­traZeneca have helped ac­cel­er­ate the de­vel­op­ment of Viela’s drugs, Yao told Bio­Space in a re­cent in­ter­view.

“It’s al­most like a con­tin­u­a­tion of Med­Im­mune,” he said.

The Med­Im­mune brand name has since been swept away in a com­pa­ny-wide R&D re­or­ga­ni­za­tion or­ches­trat­ed by chief Pas­cal So­ri­ot, which saw sev­er­al ex­ecs de­part to make way for a new struc­ture de­mar­cat­ed by on­col­o­gy.

In prepa­ra­tion for its BLA, Viela Bio has al­so inked a com­mer­cial deal with sea­soned Chi­nese phar­ma Han­soh cen­tered around inebi­lizum­ab. All told, the deal is worth up to $220 mil­lion in­clud­ing up­front and mile­stones.

The oth­er two clin­i­cal pro­grams are ME­DI4920, an an­ti-CD40L-Tn3 fu­sion pro­tein for an in­flam­ma­to­ry con­di­tion called pri­ma­ry Sjö­gren’s syn­drome, and ME­DI7734 for myosi­tis.

HBM Health­care In­vest­ments led the round, which saw a num­ber of new in­vestors in­clud­ing Viking Glob­al In­vestors, Cor­morant As­set Man­age­ment, Ter­ra Mag­num Cap­i­tal Part­ners, Gold­man Sachs, and Bar­er & Son Cap­i­tal. Temasek was the on­ly ex­ist­ing backer named in the re­lease; the pre­vi­ous syn­di­cate al­so fea­tured Boyu Cap­i­tal, 6 Di­men­sions Cap­i­tal and Hill­house Cap­i­tal.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Getty Images

UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.