J&J antes $50M to get Zymework­s' 6th big bis­pecifics al­liance un­der­way, with $6B in to­tal mile­stones on the ta­ble

New­ly pub­lic Zymeworks $ZYME has just lined up its 6th ma­jor bio­phar­ma dis­cov­ery al­liance, this time bring­ing J&J $JNJ in­to a fold that al­ready in­cludes such big play­ers as Mer­ck, Eli Lil­ly, Cel­gene, GSK and Dai­ichi Sankyo. And this deal starts with a sub­stan­tial — for a dis­cov­ery deal — up­front along with $1.4 bil­lion in to­tal mile­stones on the ta­ble.

Zymeworks’ some­what bat­tered shares took off on the news, spik­ing 38% Mon­day morn­ing.

As in some of its oth­er deals, Zymeworks is bring­ing its Azy­met­ric and EFECT plat­forms to the ta­ble — this time look­ing to iden­ti­fy 6 bis­pecifics for a slate of un­de­clared tar­gets picked by Janssen. And J&J is pay­ing $50 mil­lion to get things start­ed with an­oth­er $282 mil­lion in de­vel­op­ment mile­stones and $1.12 bil­lion in com­mer­cial cash on the line for suc­cess­ful work.

Ali Tehrani

Zymeworks CEO Ali Tehrani tells me that this brings the grand to­tal of biobucks now up for grabs to about $6 bil­lion, with around $100 mil­lion claimed in up­fronts and sup­port pay­ments from part­ners.

That’s about all the de­tail you’re go­ing to get on this par­tic­u­lar pact. Tehrani can’t go in­to specifics, a com­mon as­pect of any re­search pact this ear­ly in the game. But he does al­low that J&J isn’t look­ing at this in a nar­row frame­work, in­stead tak­ing a “broad mind­set” on what Zymeworks can do.

This has been some­thing of a tough year for Zymeworks. The Van­cou­ver-based biotech — which has been ab­sorb­ing new plat­form tech in a fast-paced dri­ve to ex­pand al­liances as it went af­ter its own in-house pro­grams — took in $59 mil­lion on its IPO af­ter pen­cil­ing in a high­er fig­ure, then watched its share price grad­u­al­ly slide to about half of the open.

The lock­up on the stock end­ed a cou­ple of weeks ago, says the CEO, and he’s hap­py enough with where the com­pa­ny is on the street. Franklin Tem­ple­ton and Cor­morant came in on the stock. He ex­pects more such longterm in­vestors to fol­low, with a new road show in the off­ing. About $40 mil­lion of the stock was spo­ken for go­ing in, a com­mon fea­ture in the biotech IPO world, and now every time a gen­er­al­ist sells a thou­sand shares on a thin­ly trad­ed stock like this, it can have a big im­pact on the price.

“Our ob­jec­tive was to in­tro­duce the street (to Zymeworks) piece by piece,” he says. And that means deals like this, more da­ta on the in-house drug ZW25, with an up­date com­ing at the San An­to­nio Breast Can­cer Sym­po­sium and a splash planned for AS­CO next sum­mer.

“If you look at every con­ver­sa­tion we’ve had,” Tehrani tells me, “you know we promise and we de­liv­er. We do what we say.”

And as the biotech per­forms for Wall Street, he be­lieves that mes­sage will res­onate and the price will head back up. As it did this morn­ing.

He’s promised. Now he gets to de­liv­er.

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.

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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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. 

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.