Seat­tle Ge­net­ics gets a PhI­II win for Ad­cetris, but shares slide as frets linger

Seat­tle Ge­net­ics $SGEN has had a rough Q2 as its lead ex­per­i­men­tal ther­a­py was put back on hold, forc­ing in­ves­ti­ga­tors to scrap Phase III short­ly af­ter the biotech had to drop a deal with Im­munomedics. But it’s wind­ing up the quar­ter with a ma­jor win in its fa­vor, post­ing a hit in its close­ly-watched Ech­e­lon-1 study for front­line Hodgkin lym­phoma.

The big biotech says that its flag­ship ther­a­py, Ad­cetris, com­bined with a trio of stan­dard drugs beat a 4-drug main­stay cock­tail ther­a­py in front­line Hodgkin dis­ease for mod­i­fied pro­gres­sion-free sur­vival over a lengthy two-year stretch. The Ad­cetris pack­age ex­clud­ed bleomycin, which has been linked to a high­er rate of lung tox­i­c­i­ty and was used in the 4-drug com­bo con­trol.

Clay Sie­gall

Com­pa­ny ex­ecs tell me that they’re prep­ping an FDA ap­pli­ca­tion an­tic­i­pat­ed for lat­er this year. Seat­tle Ge­net­ics con­trols the US and Cana­di­an mar­kets for Ad­cetris, with its part­ner Take­da tak­ing on the rest of the world.

An­a­lysts have been watch­ing this key cat­a­lyst close­ly, look­ing to see if Seat­tle Ge­net­ics has a good chance of sig­nif­i­cant­ly ex­pand­ing its rev­enue from Ad­cetris. The an­swer to that would ap­pear to be a con­di­tion­al yes, based on the biotech’s top-line da­ta.

The Ad­cetris com­bo hit a two-year mod­i­fied PFS rate of 82.1% com­pared to 77.2% in the con­trol arm — a 4.9 point, or 6%, im­prove­ment. That’s sta­tis­ti­cal­ly sig­nif­i­cant, but not the wider, dou­ble-dig­it mar­gin that the bulls have been look­ing for, ac­cord­ing to a re­cent deep dive on this sub­ject from Leerink.

An­a­lysts there have not­ed that with­out a 10%-plus mar­gin in its fa­vor, pay­ers may just stick with the cheap­er stan­dard. The dif­fer­ence could amount to hun­dreds of mil­lions of dol­lars for Seat­tle Ge­net­ics by 2025.

In­vestors weren’t hap­py with the num­bers. Seat­tle Ge­net­ics’ shares dropped 11% as the da­ta sank in on Wall Street. Some of the ear­ly re­ac­tions on Twit­ter were al­so crit­i­cal.

You al­ways pre­fer a bet­ter re­sponse, Seat­tle Ge­net­ics CEO Clay Sie­gall told me in a pre­view of the an­nounce­ment. But this marks a clear win for pa­tients and a plus for the com­pa­ny as Sie­gall re­mains de­ter­mined to make Ad­cetris a bil­lion dol­lar-plus block­buster.

“We did a pret­ty au­da­cious tri­al,” Sie­gall says. “Peo­ple said you’re try­ing to build on some­thing that al­ready looks pret­ty good…There wasn’t a lot of head­room.”

Ad­cetris and the com­bo de­liv­ered a 23% re­duc­tion in risk of pro­gres­sion, he says, build­ing the num­ber of durable re­spons­es among pa­tients who are of­ten di­ag­nosed in their twen­ties and thir­ties. In ad­di­tion, he says, doc­tors clear­ly want to elim­i­nate bleomycin and the risk of lung tox­i­c­i­ty, of­fer­ing an­oth­er ad­van­tage for Ad­cetris.

Seat­tle Ge­net­ics added that an in­ter­im look at over­all sur­vival rates — the sec­ondary to watch — ap­peared to be “trend­ing” in its fa­vor at the in­ter­im point. That’s not un­ex­pect­ed. It will prob­a­bly take 4 years to reach a con­clu­sion on OS, says the CEO, in this pop­u­la­tion.

There’s al­so like­ly to be con­tin­ued chat­ter about in­ves­ti­ga­tors’ use of “mod­i­fied” PFS in the study.

Rather than stick with track­ing the time un­til dis­ease pro­gres­sion, re­searchers mod­i­fied the end­point to in­clude the use of an ad­di­tion­al ther­a­py for pa­tients who had a “cer­tain lack of re­sponse,” says the CEO, who added that that is a sim­plis­tic de­f­i­n­i­tion. If ap­proved, says Sie­gall, this would be Ad­cetris’ 5th OK, with ear­li­er ex­pan­sions help­ing to con­tin­ue to widen the mar­ket for their drug.

Sie­gall al­so says that the pipeline at Seat­tle Ge­net­ics con­tin­ues to of­fer some stel­lar prospects for beef­ing up its port­fo­lio of mar­ket­ed drugs. The biotech re­mains ready to do new deals, he says, but on­ly on an ‘as want­ed’ ba­sis as op­posed to an ‘as need­ed’ ba­sis.

“We think Ad­cetris has an ex­cel­lent chance of be­ing a bil­lion-dol­lar drug in the US,” says the CEO. The next year will pro­vide some in­sights in­to just how like­ly that is.

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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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.

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.

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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