Bing Yao. Viela Bio

On track for first au­toim­mune drug ap­proval, Bing Yao steers As­traZeneca spin­off to $150M IPO

Just days af­ter Viela Bio se­cured its first PDU­FA date for its lead au­toim­mune drug, the As­traZeneca spin­off is con­fi­dent­ly gun­ning for a $150 mil­lion IPO.

The biotech is ded­i­cat­ing most of the pro­ceeds to three as­sets — out of six it got from a cleanup at Med­Im­mune be­fore the bi­o­log­ics unit got re­struc­tured al­to­geth­er. Chief among them would be inebi­lizum­ab, the an­ti-CD19 drug that’s be­ing ush­ered through the BLA ap­proval process for neu­romyelitis op­ti­ca spec­trum dis­or­der, prepped for com­mer­cial­iza­tion and ex­plored in ad­di­tion­al in­di­ca­tions. Then there’s al­so the CD40L-tar­get­ing VIB4920, for which Phase II stud­ies are planned for lat­er this year; and the Phase Ib an­ti­body VIB7734, which in­hibits ILT7.

One of the pro­grams from Med­Im­mune, though, seem­ing­ly did not make the cut in­to their pipeline, ac­cord­ing to the S-1.

Viela Bio has moved fast since its $250 mil­lion launch in Feb­ru­ary 2018, splash­ing $216.7 mil­lion to-date while pick­ing up a $75 mil­lion Se­ries B along the way. That leaves CEO Bing Yao with $189 mil­lion in cash and cash equiv­a­lents — with the new in­fu­sion of cash, the run­way will ex­tend to 2022.

The com­mer­cial team field­ing inebi­lizum­ab for NMOSD will be fac­ing an en­trenched rare dis­ease ri­val in Alex­ion, which just re­cent­ly won an ex­pand­ed la­bel for Soliris. In­stead of hit­ting the B cells se­cret­ing au­toan­ti­bod­ies, Soliris blocks the sub­se­quent ac­ti­va­tion of the com­ple­ment sys­tem. Roche/Chugai’s satral­izum­ab was al­so list­ed as po­ten­tial com­pe­ti­tion.

But for Viela Bio, the val­ue of inebi­lizum­ab lies in its po­ten­tial to ad­dress a slate of dis­eases. They will put that hy­poth­e­sis to test in up­com­ing mid- and late-stage tri­als for kid­ney trans­plant de­sen­si­ti­za­tion, myas­the­nia gravis and IgG4-re­lat­ed dis­or­ders.

In its SEC fil­ing, the com­pa­ny al­so laid out just how ex­ten­sive its ties with As­traZeneca are. In ad­di­tion to a 38.4% stake, the phar­ma gi­ant has mul­ti­ple agree­ments in place to sup­ply clin­i­cal and com­mer­cial drug sub­stances and prod­ucts to Viela Bio. And that’s not to men­tion Yao’s top team, as well as a sig­nif­i­cant por­tion of the R&D crew, had mi­grat­ed from Med­Im­mune.

Dur­ing his first year, Yao took home a com­pen­sa­tion pack­age worth more than $2.4 mil­lion, in­clud­ing $936,047 in stock awards and $895,500 in op­tion awards. Jörn Drap­pa, who heads R&D, comes in next with $1.3 mil­lion; BD chief Aaron Ren was re­ward­ed with $747,032 to­tal; while CFO Mitchell Chan got $402,617.

The close re­la­tion­ship al­so means Viela Bio in­her­it­ed a num­ber of li­cens­ing pacts from Med­Im­mune, which en­tail mile­stone and roy­al­ty pay­ments to Duke Uni­ver­si­ty, SBI Biotech, Dana-Far­ber Can­cer In­sti­tute, BioWa and Lon­za.

Aside from As­traZeneca Sean Tong of Boyu Cap­i­tal (who’s al­so on Viela Bio’s board) and Bound­less Mead­ow Lim­it­ed claim the largest chunk of shares, each at 18.4%. Ed­ward Hu of WuXi (9.2%), 6 Di­men­sions (9.2% to­tal), HH RSV-MIM Hold­ings (9.2%) and TLS Be­ta (7.6) fol­low.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB