Pfiz­er, Mer­ck KGaA say their PD-L1 Baven­cio al­so flunked PhI­II in the all-im­por­tant lung can­cer field

Play­ing catch-up in the crowd­ed PD-1/L1 field in can­cer R&D is prov­ing par­tic­u­lar­ly tough for Mer­ck KGaA and Pfiz­er $PFE.

The part­ners re­port­ed this morn­ing that their Phase III lung can­cer study JAVELIN Lung 200 failed the pri­ma­ry end­point for over­all sur­vival com­par­ing Baven­cio (the PD-L1 avelum­ab) against do­c­etax­el in sec­ond-line lung can­cer, a ma­jor field for all the play­ers in this par­tic­u­lar field.

Re­searchers swift­ly fin­gered the crossover of pa­tients to oth­er avail­able check­points as a like­ly rea­son for the flop — rais­ing a threat that may well arise for every­one test­ing check­points in the all-im­por­tant group of lung can­cer pa­tients.

De­tails are scant as the da­ta will be pre­sent­ed at an up­com­ing con­fer­ence, but the part­ners made sure to pro­vide an ex­pla­na­tion:

While the tri­al did not meet its pre­spec­i­fied end­point of im­prov­ing over­all sur­vival (OS) in pa­tients with pro­grammed death lig­and-1-pos­i­tive (PD-L1+) (1% or high­er) tu­mors (HR: 0.90 [96% CI: 0.72–1.12], p-val­ue 0.1627, one-sided), the pro­por­tion of pa­tients in the chemother­a­py arm cross­ing over to im­mune check­point in­hibitors out­side the study was high­er than pre­vi­ous­ly re­port­ed in post-plat­inum im­munother­a­py clin­i­cal tri­als, and this may have con­found­ed this tri­al out­come.

Re­searchers al­so point­ed to im­prove­ments in OS in a sub-group with mod­er­ate-to-high and high PD-L1+ ex­pres­sion, as well as lack of new safe­ty con­cerns, as pos­i­tive signs. But they face some tough com­peti­tors in lung can­cer, where Mer­ck has been mak­ing head­way with Keytru­da as Bris­tol-My­ers Squibb and As­traZeneca fight to gain ground. And the com­pa­nies got some kick­back from Ever­core ISI’s Uber Raf­fat: “The news to­day on Pfiz­er’s 2L lung fail­ure marks the first time we can start to say that PFE may have un­der­per­formed.”

Raf­fat al­so ques­tioned if crossovers could re­al­ly ex­plain the set­back, as Mer­ck has re­port­ed suc­cess be­fore in stud­ies with a 15% crossover rate.

The two big part­ners won an ap­proval to use their PD-L1 drug against Merkel cell car­ci­no­ma, but they’re find­ing it tough ex­pand­ing its use to oth­er can­cers. Just a cou­ple of months ago they al­so re­port­ed that Baven­cio had failed a Phase III study for gas­tric can­cer, putting a crimp in their plans to ramp up sales.

Chris Boshoff

“We are com­mit­ted to un­der­stand­ing the da­ta in the con­text of the sub­pop­u­la­tions and the im­pact of ac­cess to oth­er im­mune check­point in­hibitors,” said Chris Boshoff, a se­nior vice pres­i­dent and head of im­muno-on­col­o­gy at Pfiz­er. “We will con­tin­ue to progress the broad avelum­ab pro­gram, ex­plor­ing var­i­ous in­di­ca­tions.”

With con­tri­bu­tion from John Car­roll.

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.

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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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.

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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