FDA quash­es block­buster dreams at Eli Lil­ly and In­cyte, of­fer­ing a se­vere­ly lim­it­ed ap­proval for Olu­mi­ant

Vi­sions of block­buster sales for the rheuma­toid arthri­tis drug baric­i­tinib were quashed by the FDA’s ap­proval to­day. Reg­u­la­tors came through with an OK for the low, 2 mg dose of the drug, to be mar­ket­ed as Olu­mi­ant, spurn­ing the 4 mg dose that they had been seek­ing and lim­it­ing the pa­tient pop­u­la­tion to TNF re­sis­tant cas­es.

The reg­u­la­to­ry OK al­so comes with a black box warn­ing for the drug’s side ef­fects, which in­cludes a star­tling sig­nal on throm­boem­bolism.

Once tapped as a top fran­chise play­er for Eli Lil­ly $LLY and its part­ners at In­cyte $IN­CY, the FDA hauled the drug back from lim­bo af­ter the ar­rival of Scott Got­tlieb as com­mis­sion­er at the FDA. The agency had ini­tial­ly re­ject­ed the drug, de­mand­ing a new study. But then reg­u­la­tors abrupt­ly re­versed them­selves — with­out ex­pla­na­tion — and let the mar­ket­ing ap­pli­ca­tion pro­ceed.

De­spite the com­mer­cial set­back, Lil­ly plans to come out swing­ing for as much mar­ket share as it can grab. The phar­ma gi­ant says it will of­fer Olu­mi­ant at a 60% dis­count to the price of the lead­ing TNF in­hibitor.

“We are pleased to pro­vide RA pa­tients in the U.S. an ef­fec­tive treat­ment op­tion with Olu­mi­ant, as peo­ple with RA who have had an in­ad­e­quate re­sponse to TNF in­hibitors are gen­er­al­ly con­sid­ered to be some of the most dif­fi­cult to treat RA pa­tients,” said Christi Shaw, pres­i­dent, Lil­ly Bio-Med­i­cines.

To­day’s de­ci­sion fol­lows an ex­pert pan­el vote which weighed heav­i­ly against the 4 mg dose af­ter agency ex­perts out­lined their con­cerns about the safe­ty pro­file. They al­so gave a thumbs up to the 2 mg dose, which is like­ly to be far less suc­cess­ful and not near­ly as com­mer­cial­ly vi­able as the 4 mg. Some an­a­lysts were al­so shak­ing their heads to­day at the re­stric­tion to pa­tients who were re­sis­tant to TNF in­hibitors.

“The Olu­mi­ant ap­proval was a bit worse than the pan­el’s rec­om­men­da­tion,” Mor­gan Stan­ley an­a­lyst David Risinger said, ac­cord­ing to a re­port from Reuters.

Elim­i­nat­ing the 4 mg dose, notes Leerink’s Ge­of­frey Porges, gives Pfiz­er’s Xel­janz a big edge with 6 years of safe­ty da­ta. He adds:

Ul­ti­mate­ly this la­bel means that Olu­mi­ant is like­ly to be re­strict­ed to sal­vage ther­a­py on­ly, and ex­pect fore­casts for the prod­uct to de­cline even fur­ther (Lil­ly con­sen­sus re­mains >$1bn). This doesn’t mean that Ab­b­Vie’s upadac­i­tinib and Gilead’s fil­go­tinib will au­to­mat­i­cal­ly get this la­belling. In fact, it is like­ly that one or both of them avoids the throm­bo­sis risk and gets mul­ti­ple dos­es ap­proved with su­pe­ri­or ef­fi­ca­cy. We be­lieve that the best of the JAKs is still fil­go­tinib, un­til proven oth­er­wise, but the class as a whole is like­ly to be sad­dled with much of the lan­guage in to­day’s Olu­mi­ant la­bel.

This marks the sec­ond big set­back for In­cyte this year, af­ter its IDO pro­gram foundered and scut­tled a whole line­up of com­bi­na­tion stud­ies with ma­jor in­dus­try play­ers.

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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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.

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.

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.

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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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. 

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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While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.