FDA ex­perts shrug off retinopa­thy con­cerns, of­fer (near) unan­i­mous thumbs up for No­vo Nordisk's semaglu­tide

An FDA pan­el of out­side ex­perts to­day vot­ed al­most unan­i­mous­ly to en­dorse No­vo Nordisk’s next big di­a­betes/obe­si­ty drug semaglu­tide, like­ly set­ting up a near-term ap­proval for one of this year’s top block­busters in the pipeline. There was one ab­sten­tion and ze­ro op­po­si­tion to the key ques­tion.

No­vo Nordisk is a ma­jor play­er in di­a­betes and pre­dictably ran a thor­ough late-stage ef­fort to nail down their drug’s abil­i­ty to low­er HbA1c — a crit­i­cal mea­sure for the con­trol of the dis­ease. In the process, though, they al­so care­ful­ly tracked in­ci­dents of di­a­bet­ic retinopa­thy — dam­age to the blood ves­sels in the eye, which can lead to blind­ness — spot­light­ing what would be­come a big is­sue for its sci­en­tists on Wednes­day.

Ac­cord­ing to No­vo Nordisk, no one else has done sim­i­lar eye ex­ams as re­searchers de­cid­ed to do in their big SUS­TAIN 6 out­comes study. In their case, the sci­en­tists main­tained that the drug wasn’t di­rect­ly re­spon­si­ble for in­ci­dents of retinopa­thy, but rather pinned the blame for the cas­es on the sud­den drop in HbA1c which the drug was re­spon­si­ble for. And that risk could be man­aged, the com­pa­ny says, through the right warn­ing la­bel to alert pa­tients who are at risk.

The FDA, while of­fer­ing a clear nod for the drug’s ef­fi­ca­cy pro­file, made these retinopa­thy cas­es the cen­tral fea­ture of the pan­el dis­cus­sion, ask­ing the ex­perts to ei­ther sign off on the ad­verse safe­ty is­sue as some­thing that could be man­aged or stop the drug now un­til more da­ta could be gath­ered.

Eli Lil­ly has a lot rid­ing on the fi­nal out­come for No­vo Nordisk. In its last big Phase III tri­al, SUS­TAIN 7, re­searchers pit­ted semaglu­tide against Lil­ly’s up-and-com­ing GLP-1 drug Trulic­i­ty, and beat it. An ag­gres­sive mar­keter, No­vo will go toe-to-toe with Lil­ly in the glob­al di­a­betes mar­ket if it gets the chance.

No­vo is al­so de­vel­op­ing semaglu­tide specif­i­cal­ly for obe­si­ty, a mar­ket that has de­fied sev­er­al re­cent at­tempts by small biotechs with on­ly rel­a­tive­ly mod­est amounts of weight loss to boast about. And there is al­so a pro­gram un­der­way in NASH.

Pegged as a po­ten­tial $2.2 bil­lion drug in 5 years in one re­cent as­sess­ment, No­vo ex­ecs dur­ing their Q2 call re­viewed the Phase II obe­si­ty da­ta they had nailed down in June, out­lin­ing plans for a loom­ing Phase III that they be­lieve can show their GLP-1 drug can knock off up to around 15% of an obese per­son’s weight rel­a­tive to place­bo.

If semaglu­tide gets a clean bill of health from reg­u­la­tors, as ap­pears like­ly, No­vo can start test­ing those fore­casts.

It’s al­so worth not­ing that an ap­proval here would shove up the FDA’s record for 2017 to 35 or more, putting it on track to re­turn to the strong ap­proval rate for new drugs reg­u­la­tors scored in 2015, be­fore see­ing a big dropoff in 2016. The FDA has al­ready reg­is­tered a record num­ber of OKs on the gener­ics front, as new com­mis­sion­er Scott Got­tlieb fol­lows through on his list of goals at the FDA.

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.

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. 

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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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.