Prep­ping a case for canakinum­ab, No­var­tis tries to stake out a high-val­ue seg­ment of huge car­dio mar­ket

No­var­tis prob­a­bly al­ready has the da­ta it needs for a reg­u­la­to­ry ap­proval of its big car­dio drug canakinum­ab. Now it says it has the da­ta in hand for a big piece of the mar­ket that pay­ers won’t be able to turn their noses up at.

Us­ing a sim­ple bio­mark­er test, No­var­tis’ $NVS de­vel­op­ment chief, and soon CEO, Vas Narasimhan says that the drug proved more clear­ly im­pact­ful for heart at­tack pa­tients whose hsCRP lev­el — a mea­sure of in­flam­ma­tion us­ing high-sen­si­tiv­i­ty C-re­ac­tive pro­tein — fell be­low 2mg/L af­ter three months of treat­ment. By that score, they tracked a 31% re­duc­tion in car­dio­vas­cu­lar death and a 31% re­duc­tion in all-cause mor­tal­i­ty.

Vas Narasimhan

Put an­oth­er way, treat­ing 16 peo­ple for 5 years would pre­vent one death, heart at­tack, stroke or coro­nary revas­cu­lar­iza­tion in the sub-group, com­pared to 24 pa­tients for the en­tire pop­u­la­tion stud­ied in the mas­sive 10,000-pa­tient tri­al that ran 6 years.

“We set out to iden­ti­fy a sub­group with high­er ef­fi­ca­cy,” Narasimhan told a group of re­porters ahead of the re­lease. And they found one where they be­lieve their drug can demon­strate a high­er val­ue.

“Im­por­tant­ly, these da­ta al­so sup­port the val­ue of tar­get­ing in­flam­ma­tion when treat­ing pa­tients who have had a heart at­tack in the past, re­in­forc­ing that ‘low­er is bet­ter’ when it comes to lev­els of in­flam­ma­tion,” says Paul Rid­ker, the CAN­TOS study chair­man and di­rec­tor of the Cen­ter for Car­dio­vas­cu­lar Dis­ease Pre­ven­tion at Brigham and Women’s Hos­pi­tal.

Paul Rid­ker

The num­bers are acute­ly im­por­tant for No­var­tis, which would clear­ly like to avoid the ex­pe­ri­ence of Re­gen­eron/Sanofi and Am­gen, which field­ed big new cho­les­terol drugs for car­dio pa­tients on­ly to find pay­ers throw­ing up steep road blocks at every turn to pre­vent the re­im­burse­ment need­ed to make sales. Am­gen in par­tic­u­lar trum­pet­ed sig­nif­i­cant car­dio risk re­duc­tion for their ther­a­py, on­ly to see pay­ers re­main stub­born­ly op­posed to it with­out clear ev­i­dence of a mor­tal­i­ty ben­e­fit.

What No­var­tis is aim­ing for is a drug that can be used in tan­dem with a cho­les­terol ther­a­py, and now it has to come up with a com­pelling enough eco­nom­ic ar­gu­ment in its fa­vor to jus­ti­fy what­ev­er price it has in mind.

An­a­lysts are keen­ly aware of the chal­lenges No­var­tis faces, es­pe­cial­ly af­ter see­ing the phar­ma gi­ant strug­gle to gain mar­ket trac­tion for En­tresto and be­ing forced to con­cede that its big block­buster hope­ful sere­lax­in was a flop. But they al­so ap­pre­ci­ate the po­ten­tial here.

The drug, sold as Ilaris for a niche mar­ket, is on track to earn $380 mil­lion this year. And con­sid­er­ing da­ta on an added risk of in­fec­tion as well as some ex­pert fret­ting about the some­what fuzzy clar­i­ty of the ben­e­fit ini­tial­ly on dis­play, Tim An­der­son pegged the peak sales at a con­sen­sus of $800 mil­lion, while not­ing that patent pro­tec­tion should run out in on­ly 7 years.

There is a side ben­e­fit to this drug that No­var­tis is still try­ing to puz­zle out. The drug pro­duced a re­duc­tion in lung can­cer mor­tal­i­ty of 77%, un­der­scor­ing their the­o­ry that in­hibit­ing IL-1ß could pro­duce promis­ing da­ta in on­col­o­gy.

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.

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.

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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