Tiny In­nate re­ports a PhI­Ib dis­as­ter, bat­ter­ing shares — and a NY con­gress­man

Reps. Chris Collins, R-NY, left, and Robert Pit­tenger, R-NC, leave a meet­ing of the House Re­pub­li­can Con­fer­ence in the Capi­tol on June 7, 2017. CQ Roll Call

Just about every­thing the lit­tle Aus­tralian biotech In­nate Im­munother­a­peu­tics tracked in its Phase IIb study of its ex­per­i­men­tal drug for mul­ti­ple scle­ro­sis points to a dis­as­ter. The da­ta on all 93 pa­tients in the study demon­strate a clear fail­ure of the drug to de­liv­er an im­prove­ment for pa­tients on any of “mul­ti­ple” end­points. The dropout rate in the drug arm was high. And the rate of se­ri­ous ad­verse events was high­er in the drug arm than in the con­trol group.

Rep. Chris Collins (R-NY)

In­nate (ASX Code: IIL) is go­ing back over the da­ta to see if the per pro­to­col re­sults on just the pa­tients who had com­plet­ed a siz­able por­tion of the study did any bet­ter. But in­ves­ti­ga­tors aren’t try­ing to en­cour­age any­one to be­lieve in MIS416, de­liv­ered by IV once a week for a year. They say there is no rea­son to ex­pect a change in out­comes.

All that is bad enough on its own. But even so, you may nev­er have heard about any of this but for one fact: A promi­nent US con­gress­man bet the ranch on this com­pa­ny’s stock — and ev­i­dent­ly lost vir­tu­al­ly all of it. In­nate’s stock al­most dis­ap­peared af­ter in­vestors got a look at the da­ta, falling to a few pen­nies a share.

Bloomberg re­porters, who have been cov­er­ing this sto­ry, did the math and con­clud­ed that New York Re­pub­li­can Chris Collins, In­nate’s biggest share­hold­er and a long­time be­liev­er, lost $16.7 mil­lion af­ter tak­ing the fli­er. And ev­i­dent­ly a num­ber of oth­er Re­pub­li­cans, in­clud­ing HHS Sec­re­tary Tom Price, al­so lost mon­ey as well.

HHS Sec­re­tary Tom Price

The con­nec­tions be­tween law­mak­ers in charge of health­care pol­i­cy and In­nate have now re­port­ed­ly in­spired an ethics in­ves­ti­ga­tion in­to the role Collins played in at­tract­ing in­vestors to the com­pa­ny. And in a sto­ry this morn­ing, The Buf­fa­lo News re­port­ed that the FDA had just grant­ed the biotech an IND to launch tri­als in the US, void­ing the con­gress­man’s claim that he had no con­flicts be­cause the biotech nev­er had busi­ness in front of US reg­u­la­tors.

The biggest les­son from all this, though, may be that any­one who bets a large por­tion of their wealth on a biotech long shot like this — based in Syd­ney — doesn’t know much about in­vest­ing, biotech or health­care. Collins, for his part, doesn’t agree. “For those that in­vest­ed in In­nate, in­clud­ing me, we all were so­phis­ti­cat­ed in­vestors who were aware of the in­her­ent risk,” Collins says in a pre­pared state­ment. He adds: “For every suc­cess­ful drug, there are count­less num­bers that fail. That’s how to­day’s sys­tem works.”

Si­mon Wilkin­son, In­nate Im­munother­a­peu­tics’ chief ex­ec­u­tive said: “These re­sults are a shock and def­i­nite­ly not what we were ex­pect­ing based on our pre­vi­ous clin­i­cal ex­pe­ri­ence with MIS416 and the re­port­ing of treat­ment ben­e­fits we have re­ceived from many com­pas­sion­ate use pa­tients over an ex­ten­sive 8-year pe­ri­od. These da­ta will be as dis­tress­ing to them as they will be for all the stake­hold­ers who were re­ly­ing on the out­come of this study.”

Wilkin­son can count his biggest in­vestor and biggest los­er as one of the most bad­ly shocked of all.

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.