Af­ter a se­ries of PI3k pile­ups, Genen­tech of­floads a PhII-ready ri­val for fire­sale price

Why would Genen­tech, of all bio­phar­ma com­pa­nies, out-li­cense a PI3k in­hibitor for on­ly $5 mil­lion? That’s a ques­tion a few biotechs may be ask­ing them­selves this morn­ing af­ter see­ing the terms in a deal be­tween the biotech gi­ant and lit­tle Aus­tralian biotech Novo­gen.

Genen­tech de­cid­ed to of­fload GDC-0084 af­ter com­plet­ing a Phase I study of the drug for glioblas­toma. Novo­gen ($NVGN) ac­knowl­edges that there have been sev­er­al PI3k in­hibitors in de­vel­op­ment, but says that this one is dis­tin­guished by its abil­i­ty to cross the blood-brain bar­ri­er to reach the most com­mon form of brain can­cer.

Genen­tech is al­so hand­ing over enough of the drug for Novo­gen to roll out a Phase II study next year, mak­ing it a play­er in PI3k.

That’s a nice lit­tle deal for Novo­gen. But it could be seen as the lat­est in a se­ries of omi­nous turns for biotechs like In­fin­i­ty, which are still try­ing to make progress in this field. Genen­tech is known for oc­ca­sion­al­ly buy­ing or li­cens­ing the par­tic­u­lar drugs it needs to full out a packed pipeline. It’s not much at all known for hand­ing out drugs that no longer fit.

But PI3k in­hi­bi­tion isn’t the lure that it once was, and big bio­phar­ma has been bail­ing out.

In April As­traZeneca sim­ply cut AZD8835, a PI3K al­pha/delta in­hibitor in stud­ies for sol­id tu­mors. And that move came just two months be­fore Ab­b­Vie opt­ed to spurn its $805 mil­lion col­lab­o­ra­tion with In­fin­i­ty $IN­FI, even though their PI3K delta/gam­ma drug du­velis­ib had pro­duced a pos­i­tive set of da­ta in a piv­otal tri­al. It just wasn’t com­pet­i­tive enough.

TG Ther­a­peu­tics al­so has an oral PI3k in­hibitor – TGR-1202 – in the clin­ic.

All these re­treats fol­lowed a ma­jor prob­lem for Gilead’s first-in-class PI3k in­hibitor Zy­delig (ide­lal­is­ib) which was ap­proved in 2014. In March, though, the com­pa­ny was forced to stop 6 stud­ies due to safe­ty is­sues. And that came af­ter the drug was clear­ly los­ing a race with J&J’s Im­bru­vi­ca from J&J and Ab­b­Vie on leukemia and lym­phoma. Ab­b­Vie and Roche’s vene­to­clax, mean­while, is ex­pect­ed to gain mar­ket ground in CLL.

Im­bru­vi­ca’s po­si­tion on the mar­ket al­so was seen as a deal killer for du­velis­ib.

Add it all up and you can see how the PI3k field – once a hot prospect in R&D cir­cles – has been dec­i­mat­ed in re­cent months.

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.

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.

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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