No­var­tis spot­lights its top 4 block­buster late-stage pipeline projects

Over the past year the R&D group at No­var­tis $NVS has de­vel­oped one of the most mus­cu­lar late-stage pipeline strate­gies in Big Phar­ma. They kept their lead in CAR-T and drove home the first ap­proval in the field, and they have 4 Phase III ef­forts un­der­way which they are show­cas­ing dur­ing to­day’s R&D day in Lon­don.

The spot­light il­lus­trates where this phar­ma gi­ant — one of the top three among the glob­al R&D play­ers with a bud­get of about $9 bil­lion — plans to in­vest the great­est en­er­gy in win­ning new ap­provals. And while a whole long slate of ri­vals are ei­ther strug­gling to demon­strate that they are on to new drugs of re­al im­por­tance or find some way to in­spire in­no­va­tion, No­var­tis de­vel­op­ment chief Vas Narasimhan is un­der­scor­ing with this list why he was se­lect­ed to take the CEO’s job.

None of these drugs have a lock on big new mar­kets. But if they fall short, it won’t be for lack of try­ing.

No­var­tis’ top 4:

RTH258 (brolu­cizum­ab):

The scoop: No­var­tis ex­ecs kicked out the lat­est da­ta on Fri­day demon­strat­ing that this drug not on­ly lined up well against Re­gen­eron’s Eylea in wet AMD, but al­so looked bet­ter in some re­spects re­gard­ing dis­ease mod­i­fi­ca­tion. With a once-every-12-weeks ver­sus a once-every-8 weeks dos­ing reg­i­men for a ther­a­py that’s in­ject­ed in­to the eye, No­var­tis thinks it can steal a big chunk of a multi­bil­lion-dol­lar mar­ket for it­self.

Sec­ond thoughts: Re­gen­eron isn’t about to roll over on this one. They are work­ing on their own 4X per year treat­ment reg­i­men and have a next-gen drug in the pipeline that will look to do Eylea — and RTH258 — one bet­ter.

AMG 334 (erenum­ab):

The scoop: No­var­tis is part­nered with Am­gen on this CGRP mi­graine drug, which is look­ing to help set a whole new stan­dard of care in treat­ing a crip­pling ail­ment. And they have the late-stage da­ta to prove it works safe­ly. No won­der No­var­tis re­worked its deal ear­li­er this year to grab a share of the all-im­por­tant US mar­ket.

Sec­ond thoughts: They’re not alone. Eli Lil­ly, Te­va and Alder are all lin­ing up their own ri­vals, mean­ing that com­mer­cial­iza­tion is like­ly to take place amid some bru­tal com­pe­ti­tion, with pay­ers play­ing them off against each oth­er.


The scoop: No­var­tis grabbed the lead with this drug, gain­ing an ap­proval for pso­ri­a­sis 5 years ago. This year it fol­lowed up with some strong da­ta back­ing up its dura­bil­i­ty, adding im­pres­sive ex­ten­sion da­ta for anky­los­ing spondyli­tis and pso­ri­at­ic arthri­tis. And No­var­tis has big plans to rack up new ap­provals for more in­di­ca­tions. Next stop: spondy­loarthri­tis.

Sec­ond thoughts: Once again, No­var­tis is not alone. There are oth­er head-to-head ri­val drugs out there, in­clud­ing ther­a­pies from J&J (Trem­fya), Eli Lil­ly and even Valeant. No­var­tis is in a strong po­si­tion, but it can’t take any­thing for grant­ed.

ACZ885 (canakinum­ab):

The scoop: This was No­var­tis’ dark horse, the car­dio drug that sur­prised an­a­lysts with a win in demon­strat­ing how it could help a huge mar­ket of heart pa­tients. Car­dio re­mains one of the biggest dis­ease fields on the plan­et, with mas­sive com­mer­cial po­ten­tial. And No­var­tis has been con­cen­trat­ing on one seg­ment of the mar­ket in com­ing up with the kind of tar­get­ed da­ta that pay­ers won’t be al­lowed to ig­nore. An up­date on that score is ex­pect­ed quite soon.

Sec­ond thoughts: Car­dio is big, it’s al­so been mas­sive­ly dis­ap­point­ing for de­vel­op­ers. Am­gen tried and failed (so far) to win over pay­ers with its own da­ta on PC­SK9, and Mer­ck just walked away from the on­ly suc­cess­ful CETP drug be­cause the ben­e­fit for pa­tients was too mar­gin­al to gen­er­ate any com­mer­cial ex­pec­ta­tions. To win here, No­var­tis will have to prove val­ue — far be­yond what it takes to win an ap­proval.

Im­age: No­var­tis. 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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