Roche silent­ly whisks away its lead $1.7B Ser­agon drug in a Q1 foot­note

Rich Hey­man

Close to three years ago Roche’s Genen­tech team came in and bought out Ser­agon from Rich Hey­man for $725 mil­lion in cash and an­oth­er bil­lion dol­lars in mile­stones, herald­ing the po­ten­tial for se­lec­tive es­tro­gen re­cep­tor de­graders to “one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.”

To­day, the phar­ma gi­ant qui­et­ly car­ried the lead drug from that deal out to the curb, not­ing in a foot­note on pro­gram ter­mi­na­tions that it was re­mov­ing the drug GDC-0810 (ARN-810, RG6046) from Phase II.

In re­sponse to a query, Roche says that 0810 is be­ing shelved now so the com­pa­ny can move for­ward with an­oth­er one of Ser­agon’s drugs in the same field that has bet­ter po­ten­tial — and they’re just as in­ter­est­ed in SERDs as ever. Their state­ment:

Genen­tech has de­cid­ed to halt fur­ther clin­i­cal de­vel­op­ment and on­go­ing stud­ies eval­u­at­ing GDC-0810 while we eval­u­ate our strate­gic op­tions for our Se­lec­tive Es­tro­gen Re­cep­tor De­graders (SERDs) pro­gram.
We have learned much about the SERD bi­ol­o­gy with tar­get­ing the es­tro­gen re­cep­tor. Based on cur­rent da­ta, GDC-0927, an­oth­er next-gen­er­a­tion oral SERD, ap­pears to have greater po­ten­tial than GDC-0810 to be a best-in-class SERD mol­e­cule. We have de­cid­ed to move for­ward with GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER2-neg­a­tive breast can­cer build­ing up­on what we have learned in the clin­ic with GDC-0810. In Q1 2015, we ini­ti­at­ed a Phase I dose-es­ca­la­tion tri­al to as­sess the safe­ty, tol­er­a­bil­i­ty, and phar­ma­co­ki­net­ics of GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER-neg­a­tive breast can­cer who have pro­gressed af­ter re­ceiv­ing cur­rent an­ti-hor­mon­al med­i­cines.
Genen­tech re­mains com­mit­ted to con­tin­u­ing to in­vest in SERD bi­ol­o­gy and nov­el SERD ther­a­pies. We be­lieve in­ves­ti­ga­tion­al next-gen­er­a­tion oral SERDs could one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.

The re­ver­sal marks an un­usu­al set­back for Genen­tech and Roche, which rarely spend that kind of mon­ey on an ex­per­i­men­tal as­set. He­len Thomas, who was then writ­ing Heard on the Street for the Wall Street Jour­nal, found it “dis­con­cert­ing” at the time.

“Rarely in oth­er sec­tors,” she not­ed, “do com­pa­nies shell out vast sums for as­sets that could quite pos­si­bly amount to noth­ing.”

Ser­agon was what was left af­ter J&J came in and bought Aragon — Hey­man’s San Diego biotech cre­at­ed to pur­sue the in­sights of not­ed in­ves­ti­ga­tor Charles Sawyers — in one of its bil­lion-dol­lar buy­outs ($650 mil­lion in cash). Stan­dard ther­a­pies for breast and prostate can­cer are de­signed to block the ef­fect of the hor­mones, act­ing like “glue in the lock” of hor­mone re­cep­tors, then-Aragon CEO Hey­man told me back in 2010. But over time, pa­tients be­come treat­ment re­sis­tant and the ther­a­py can wind up fu­el­ing the can­cer. Hey­man called his lead ther­a­py for prostate can­cer “su­per glue. It tru­ly blocks the re­cep­tor in this re­sis­tant state.”

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.