Re­gen­eron, Sanofi post good PhI­II asth­ma da­ta for Dupix­ent — but it’s los­ing its ha­lo

Just days af­ter As­traZeneca and Am­gen man­aged to catch an­a­lysts sleep­ing with a promis­ing new asth­ma drug called teze­pelum­ab, Re­gen­eron and Sanofi are com­ing in with new da­ta for Dupix­ent (dupilum­ab) which they are bet­ting will pave the way to a new ap­proval next year.

But sev­er­al an­a­lysts are say­ing Mon­day morn­ing that the new da­ta are a step down from the ex­cit­ing mid-stage re­sults these two ma­jor league part­ners put up. And they’re won­der­ing whether Dupix­ent — a one-time dar­ling — can live up to some old ex­pec­ta­tions.

George Yan­copou­los at­tends old Spring Har­bor Lab­o­ra­to­ry’s Dou­ble He­lix Medals at Amer­i­can Mu­se­um of Nat­ur­al His­to­ry on De­cem­ber 1, 2016 in New York City. get­ty im­ages

The da­ta for un­con­trolled asth­ma looked eas­i­ly good enough for an OK as Re­gen­eron and Sanofi lined up for their next BLA with Dupix­ent.

At 52 weeks, in the 300 mg dose group, dupilum­ab re­duced se­vere asth­ma at­tacks by 46 per­cent in the over­all pop­u­la­tion, 60 per­cent in pa­tients with 150 eosinophilic cells/mi­cro­liter or greater, and 67 per­cent in pa­tients with 300 eosinophilic cells/mi­cro­liter or greater (p less than 0.001 for all groups). At 12 weeks, in the 300 mg dupilum­ab dose group, mean im­prove­ment in lung func­tion over place­bo as as­sessed by forced ex­pi­ra­to­ry vol­ume over one sec­ond (FEV1) with dupilum­ab was 130 mL (9 per­cent) in the over­all pop­u­la­tion, 210 mL (11 per­cent) in pa­tients with 150 eosinophilic cells/mi­cro­liter or greater, and 240 mL (18 per­cent) in pa­tients with 300 eosinophilic cells/mi­cro­liter or greater (p less than 0.001 for all groups).

Biren Amin at Jef­feries looked it over and sum­ma­rized it this way:

This da­ta is com­pa­ra­ble to the IL-5 Nu­cala on ex­ac­er­ba­tions re­duc­tion but su­pe­ri­or on FEV1 im­prove­ment. Based on to­day’s da­ta, we be­lieve dupi will be com­pet­i­tive but not the clear choice in asth­ma.

Said Re­gen­eron chief sci­en­tist George Yan­capolous:

Dupilum­ab has now demon­strat­ed pos­i­tive late-stage re­sults in two se­ri­ous al­ler­gic dis­eases — asth­ma and atopic der­mati­tis — with ro­bust ef­fi­ca­cy and an ex­ten­sive safe­ty data­base. These re­sults con­tin­ue to sup­port our hy­poth­e­sis that the IL4/IL13 path­way is a crit­i­cal dri­ver of al­ler­gic dis­ease, and we re­main com­mit­ted to fur­ther in­ves­ti­gat­ing the IL-4/IL-13 path­way in oth­er al­ler­gic dis­eases.

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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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 at 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.

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.

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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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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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.

Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.