As killer virus out­breaks hit un­prece­dent­ed lev­els, non­prof­it hands $37.5M to Themis to tack­le Las­sa/MERS vac­cines

A non­prof­it formed in the af­ter­math of the re­cent Ebo­la out­break is hand­ing an Aus­tri­an biotech $37.5 mil­lion to put two killer dis­eases on its vac­cine to-do list: Las­sa fever and MERS.

It’s the first deal signed since the 2017 launch of the non­prof­it, which calls it­self CEPI (pro­nounced “sep­py”) – short for the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions. The group’s goal is to build a glob­al vac­cine de­vel­op­ment fund, de­vot­ed to ready­ing pan­dem­ic de­fens­es dur­ing peace­time. It was formed by the gov­ern­ments of Nor­way, Ger­many, In­dia, and Japan, along with the Bill and Melin­da Gates Foun­da­tion, Well­come, and the World Eco­nom­ic Fo­rum.

The group hopes to raise $1 bil­lion for the fund, which it would dole out to wor­thy re­search ef­forts. They’ve al­ready raised $630 mil­lion.

This first in­fu­sion of cash is go­ing in tranch­es over a five-year pe­ri­od to Themis Bio­science, which has a plat­form tech based on the measles vac­cine that might be use­ful against mul­ti­ple virus­es.

These two in­fec­tious dis­eases are a high pri­or­i­ty for CEPI right now, and right­ly so. MERS, which hides out in camels and has been cir­cu­lat­ing the Mid­dle East since 2012, has killed a third of the peo­ple it’s in­fect­ed. And Las­sa fever, en­dem­ic to the same parts of Africa re­cent­ly hit by Ebo­la, is ex­pe­ri­enc­ing a pe­ri­od of un­prece­dent­ed out­break. Las­sa fever nor­mal­ly has a fa­tal­i­ty rate of 1%, but in the cur­rent Niger­ian out­break it is thought to be clos­er to 20%, ac­cord­ing to the CDC.

Richard Hatch­ett

“Es­tab­lish­ing our part­ner­ship with Themis rep­re­sents not on­ly an im­por­tant step in our jour­ney to­wards tack­ling these dis­eases, but al­so a break­through in how we can part­ner and work with vac­cine de­vel­op­ers when tra­di­tion­al mar­ket in­cen­tives for de­vel­op­ment have failed,” said CEPI’s CEO Richard Hatch­ett.

Themis’ CEO and founder Erich Tauber tells me there’s not enough fi­nan­cial up­side to tack­ling these dis­eases, which is why vac­cines aren’t be­ing de­vel­oped.

“The out­breaks oc­cur once every five or six years, and that’s not enough mar­ket push to get the vac­cines de­vel­oped,” Tauber said. “If a com­pa­ny like Themis went to ven­ture cap­i­tal­ists and asked for in­vest­ment to de­vel­op vac­cines for Las­sa or MERS, chances are no­body would pay us mon­ey to de­vel­op those vac­cines be­cause they are com­mer­cial risks.”

Erich Tauber

The mon­ey from CEPI will help bridge that gap. The com­pa­ny hopes the funds will take the com­pa­ny through Phase II, where de­vel­op­ment might end.

The hope, Tauber said, is to prove the vac­cines ef­fi­ca­cious in an­i­mal stud­ies and safe in large co­horts.

“But from there, the vac­cine will most like­ly have to be used on emer­gency rules,” Tauber said.

These two lat­est vac­cine projects will be added to Themis’ port­fo­lio, which in­cludes an ad­vanced pro­gram for a vac­cine against chikun­gun­ya virus, a mos­qui­to-trans­mit­ted dis­ease that can have de­bil­i­tat­ing long-term side ef­fects. That pro­gram is in Phase II tri­als in 600 pa­tients.

With its measles virus plat­form, Themis is al­so de­vel­op­ing vac­cines against Zi­ka, RSV, and norovirus, among oth­er ar­eas.

Im­age: Vi­ral dis­ease out­break. Shut­ter­stock

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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