No­vo Nordisk buys uni­ver­si­ty spin­out Ziy­lo — adding a po­ten­tial rem­e­dy for hy­po­glycemia to its di­a­betes pipeline

The busy R&D group at No­vo Nordisk is adding an ear­ly re­search pro­gram to its ar­se­nal of di­a­betes ther­a­pies.

In a “staged ac­qui­si­tion” that could be worth up to $800 mil­lion — with an up­front that the com­pa­nies aren’t dis­clos­ing — No­vo has gained full rights to some glu­cose bind­ing mol­e­cules de­vel­oped by Ziy­lo, a Bris­tol, UK-based biotech whose team will now work di­rect­ly with No­vo re­searchers in both Ox­ford and Copen­hagen.

Mar­cus Schindler

When di­a­bet­ics con­trol their con­di­tion with in­sulin, they need to con­stant­ly mon­i­tor their blood sug­ar lev­els and could some­times ex­pe­ri­ence hy­po­glycemia where the lev­els fall too low. Ziy­lo’s ex­per­tise in these syn­thet­ic mol­e­cules, com­bined with No­vo’s long­time work in in­sulin, could give birth to a new class of glu­cose re­spon­sive in­sulin mol­e­cules that are on­ly ac­tive when glu­cose lev­els are high, ac­cord­ing to Mar­cus Schindler, No­vo’s SVP of glob­al drug dis­cov­ery.

“The am­bi­tion we have is to build an in­sulin mol­e­cule that gives those peo­ple with di­a­betes a peace of mind, not hav­ing to wor­ry about hy­po­glycemic events or mon­i­tor­ing,” he said in a video ac­com­pa­ny­ing the an­nounce­ment.

Har­ry De­stre­croix

Pro­fes­sor An­tho­ny Davis at the Uni­ver­si­ty of Bris­tol first de­signed the glu­cose bind­ing mol­e­cules in the cen­ter of this deal. Har­ry De­stre­croix, then a PhD stu­dent in his lab, co-found­ed Ziy­lo and has served as its CEO since.

Just be­fore sell­ing it­self to No­vo, Ziy­lo spun out a new com­pa­ny dubbed Car­bo­met­rics to de­vel­op the di­ag­nos­tics and glu­cose mon­i­tor­ing ap­pli­ca­tions of its tech. Car­bo­met­rics, which is now the new home for all Ziy­lo re­searchers, will help No­vo op­ti­mize their glu­cose bind­ing mol­e­cules as a col­lab­o­ra­tor.

These are chemists, Schindler told me, that No­vo has ob­served and talked to for years. As the tech­nol­o­gy be­gan to look ready for fur­ther de­vel­op­ment, his team ini­ti­at­ed part­ner­ship talks but ul­ti­mate­ly found ac­qui­si­tion to be a bet­ter mod­el.

“At the end of the day, to cut a long sto­ry short, we ac­tu­al­ly felt it’s such a com­pet­i­tive area — oth­er com­pa­nies, biotechs, even not-for-prof­it or­ga­ni­za­tions are work­ing in this field — and we just want­ed to make ab­solute­ly sure that we have con­trol and own the lead­ing chem­istry that we be­lieve is out there,” he said.

The new pro­gram joins a num­ber of promis­ing pre­clin­i­cal pro­grams at No­vo, from the in-house ef­forts to find a stem cell cure for di­a­betes to the ReS39 pro­gram it li­censed from Bel­gium’s re­MYND last year, which promis­es to re­store the pan­creas’ in­sulin pro­duc­tion and in­crease in­sulin sen­si­tiv­i­ty.

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.

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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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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UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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The top 15 mega-deals in bio­phar­ma: Ab­b­Vie and Bris­tol-My­ers ac­qui­si­tions stir fresh de­bate over what's too big to buy

The debate over what’s too big to buy in biotech is back. A number of top analysts went right after AbbVie’s rationale for the Allergan deal today, just as Bristol-Myers Squibb stirred immediate debate over the worth and wisdom of acquiring Celgene.

To help provide some added context to this discussion, we asked DealForma chief Chris Dokomajilar to look over the past decade of major M&A in biopharma to decipher the top 15 plays.

The new numbers, unadjusted for inflation, harken back to the days of the Pfizer-Wyeth buyout and Merck’s decision to absorb Schering-Plough — both triggered in 2009. The heat over those acquisitions made the big pharma mega-deal highly unpopular for most everyone — except Pfizer — as industry leaders swore off almost all but the handy bolt-on acquisition.

Until recently.

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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.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.