Eli Lil­ly ush­ers up-and-com­ing GIP/GLP-1 drug in­to PhI­II as No­vo Nordisk ri­val wows with im­pres­sive re­sults

With No­vo Nordisk’s GLP-1 drug Ozem­pic (semaglu­tide) on its tail, Eli Lil­ly has round­ed up some mid-stage da­ta to show it has the right can­di­date to fol­low on Trulic­i­ty’s block­buster suc­cess in the com­pet­i­tive di­a­betes mar­ket.

In­ves­ti­ga­tors re­port that LY3298176, a dual GIP and GLP-1 re­cep­tor ag­o­nist, out­per­formed both place­bo and Trulic­i­ty (du­laglu­tide) in terms of blood sug­ar re­duc­tion and weight loss for pat­ints with type 2 di­a­betes. And while cross-tri­al com­par­isons al­ways war­rant cau­tion, the drug ap­pears to of­fer a siz­able ad­di­tion­al ef­fect over GLP monother­a­pies.

Like GLP-1, GIP is an in­cretin hor­mone tied to in­sulin se­cre­tion.

“This drug is set­ting up to be per­haps the most crit­i­cal part of LLY’s di­a­betes strat­e­gy go­ing fwd … es­pe­cial­ly in the face of No­vo’s new launch­es,” Ever­core ISI an­a­lyst Umer Raf­fat writes in a note.

In­vestors were pay­ing close at­ten­tion. Lil­ly’s stock $LLY shot up 4%, a big deal for big-cap com­pa­ny, while No­vo’s shares $NVO slid 7%.

On the pri­ma­ry ef­fi­ca­cy mea­sure — change in HbA1c from base­line to 26 weeks — 90% of those who re­ceived the 10 mg dose of LY3298176 achieved the rec­om­mend­ed HbA1c tar­get of 7% of less; the 5 mg group record 69.1% and the 15 mg group, 77.4%. Mean­while, the sin­gle du­laglu­tide and place­bo arms had 52% and 12% of pa­tients hit­ting that tar­get.

Of note, the 15 mg group ac­tu­al­ly saw a high­er per­cent­age (30%) of pa­tients achiev­ing the most im­pres­sive re­duc­tion, which is HbA1c lev­els of less than 5.7% — what you’d ex­pect to see in non-di­a­bet­ics. Among those on the 10 mg dose, 18% got to that point.

But where LY3298176 re­al­ly stood out was in the weight loss num­bers: -4.8 kg (5 mg), -8.7 kg (10 mg) and -11.3 kg (15 mg) while pa­tients on du­laglu­tide shed an av­er­age of -2.7 kg. That trans­lates to more than a third of drug arm pa­tients los­ing 10% or more of their base­line body weight.

Source: Umer Raf­fat

Click on the im­age to see the full-sized ver­sion

Re­searchers are al­so hap­py with the safe­ty pro­file, which they say is “sim­i­lar to the GLP-1 RA class” with the most com­mon­ly re­port­ed side ef­fects be­ing nau­sea, di­ar­rhea and vom­it­ing.

“We set a high bar for this Phase II study, and the re­sults ex­ceed­ed our ex­pec­ta­tions,” said Jeff Em­mick, vice pres­i­dent of prod­uct de­vel­op­ment, Lil­ly Di­a­betes. “We’re ex­cit­ed to con­tin­ue study­ing GIP/GLP-1 RA and hope to add it to our wide range of ther­a­pies for peo­ple with di­a­betes.”

It’s now time to move in­to a larg­er Phase III tri­al dubbed SUR­PASS, which Lil­ly plans to ini­ti­ate by ear­ly 2019 and com­plete in late 2021.

If the da­ta trends hold up — as Raf­fat is bull­ish it would — he sees the drug tak­ing a key po­si­tion in a bi­fur­cat­ing GLP-1 mar­ket:

  • oral se­ma will take lots of share from short-act­ing GLP-1s (where No­vo is al­ready pulling spend from Vic­toza) as well from orals
  • per­haps there will re­main a long-act­ing niche … with No­vo’s Ozem­pic and LLY’s Trulic­i­ty … LLY will like­ly shift the spend away from Trulic­i­ty and over to this GIP/GLP.
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 of­fers a rare, up­beat in­ter­pre­ta­tion of Ab­b­Vie’s $63B Al­ler­gan deal — 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.