The E100: Biotech ex­ecs are bull­ish about 2017, but fret about drug pric­ing and the FDA un­der Trump

About the End­points 100: This is our sec­ond biotech in­dus­try sur­vey, which we sent out to our in­vite-on­ly group of ex­ec­u­tives on Feb­ru­ary 6. 98 ex­ecs, pri­mar­i­ly in the US and Eu­rope, com­plet­ed the sur­vey, You can see a list of the en­tire group at the end of this ar­ti­cle.

The biotech in­dus­try is feel­ing bull­ish about its own prospects at the be­gin­ning of 2017, large­ly sat­is­fied with the fi­nan­cial sup­port that’s been flow­ing in to the field with most ex­ecs ready to hire through the year as the tem­po on deal-mak­ing re­mains up­beat.

But it’s not all com­ing up ros­es.

The in­dus­try is in a funk about the Trump ad­min­is­tra­tion af­ter a few weeks of head­lines over a trav­el ban con­tro­ver­sy and a rolling se­ries of out­spo­ken tweets, with a large seg­ment of these ex­ecs wor­ried that a new head of the FDA could come in ready to re­duce if not ac­tu­al­ly dis­card stan­dards on drug de­vel­op­ment.

And vir­tu­al­ly no mat­ter what Trump says or does, a clear ma­jor­i­ty add, we’ve en­tered a new era on drug pric­ing that will de­mand a new math on what ther­a­pies cost. As for the high-pro­file in­stances where com­pa­nies and CEOs have been fin­gered for price goug­ing, many be­lieve we’re see­ing an end game where the re­tal­i­a­tion is like­ly to be se­vere enough to stop such prac­tices for­ev­er.

That’s the bot­tom line from our lat­est End­points 100 sur­vey, which cap­tured the thoughts of a broad swathe of CEOs and top-lev­el ex­ecs in the in­dus­try.

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Down on Trump

Ful­ly two-thirds of these ex­ecs — out of 98 who re­spond­ed to our sur­vey — are deeply dis­en­chant­ed with Pres­i­dent Trump.

Thoughts ranged from “a smol­der­ing dump­ster fire with re­gards to health and hu­man safe­ty” to “his ac­tion on the im­mi­grant ban was mis­guid­ed. His in­abil­i­ty to re­frain from tweet­ing is ar­ro­gant. His ad­mi­ra­tion of Putin is fool­ish.”

A huge ma­jor­i­ty — 82% — dis­ap­proved of the pres­i­dent’s ac­tions. On­ly 4% found some­thing to ap­prove.

One of the pres­i­dent’s sig­na­ture ef­forts ear­ly on has been to blast what he calls out­ra­geous pric­ing for drugs. A big group — 63% — feel that the bio­phar­ma in­dus­try has en­tered a new era on drug pric­ing. But a strong ma­jor­i­ty of 56% be­lieve that al­low­ing Medicare to ne­go­ti­ate drug pric­ing, as Trump has said now re­peat­ed­ly, is the wrong move.

“I be­lieve that Phar­ma re­al­ly doesn’t get it,” said one ex­ec. “Ever since the fi­nan­cial cri­sis there has been a con­stant drum­beat by pa­tients, physi­cians, etc on the price of drugs. We need to be more fo­cused on bring­ing ‘val­ue for the mon­ey.’ There isn’t enough mon­ey in the world to ad­dress the world’s health­care. We need to raise the bar much high­er for our­selves and price re­spon­si­bly. We are killing the gold­en goose.”

“Trump told Phar­ma CEOs to get prices down, in­no­va­tion up and bring busi­ness­es back to the US. He means it and I be­lieve Phar­ma will self reg­u­late on bla­tant price in­creas­es (of which many are guilty).”

On­ly 24% felt that the sta­tus quo on pric­ing could be main­tained.

“Pay­ers are al­ready in­creas­ing pres­sure and there is ex­treme pres­sure in the EU. Ex­ces­sive price in­creas­es on gener­ic drugs must stop. Need to mod­er­ate price in­creas­es on drugs gen­er­al­ly to be more in line with in­fla­tion.”


Medicare price ne­go­ti­a­tions

There’s no doubt­ing the con­sid­er­able op­po­si­tion in the in­dus­try to push­ing Medicare in­to price ne­go­ti­a­tions. But a large mi­nor­i­ty, 44%, felt that there was good rea­son for Medicare price ne­go­ti­a­tions.

“Wrong move or right move, it’s an ob­vi­ous move. It’s the biggest pay­er and some­how, some way, this will hap­pen.”

None of the sol­id ma­jor­i­ty who op­posed see­ing Medicare lever­age low­er prices di­rect­ly ex­pressed their opin­ion on it.

Scott Got­tlieb

It’s ear­ly days in this ad­min­is­tra­tion, but sev­er­al of the ex­ecs who took this sur­vey ex­pect to see some fast changes out of Con­gress, some of which will like­ly spur the M&A side of the busi­ness.

“Ex­pect repa­tri­a­tion (of over­seas prof­its) which will dri­ve more col­lab­o­ra­tion/ac­qui­si­tion. Ex­pect volatil­i­ty in com­mu­ni­ca­tion from ad­min­is­tra­tion re­lat­ing to pric­ing, dri­ving con­tin­ued un­cer­tain­ty un­til ad­min­is­tra­tion clar­i­fies po­si­tion one way or an­oth­er on pric­ing.”

“The biggest im­pact they will have will be in the ap­point­ment of the HHS sec­re­tary and the head of the FDA (hope­ful­ly Scott Got­tlieb).”

“Wild­ly un­pre­dictable. Of the var­i­ous un­knowns now the no­tion that the FDA might con­vert ap­provals to “safe­ty on­ly” is the most alarm­ing.”


The FDA

There is a sig­nif­i­cant di­vi­sion of opin­ion about what the FDA should do un­der a new com­mis­sion­er. 43% said no sig­nif­i­cant changes are need­ed in terms of reg­u­la­tions, sat­is­fied that changes made over the last few years has sub­stan­tial­ly ben­e­fit­ed bio­phar­ma and stream­lined de­vel­op­ment with­out erod­ing stan­dards.

37%, though, are look­ing for sig­nif­i­cant changes.The theme, though, sug­gests the in­dus­try is look­ing for a con­tin­ued evo­lu­tion of the reg­u­la­to­ry land­scape, fa­vor­ing de­vel­op­ers but not gut­ting the gold stan­dard on ef­fi­ca­cy and safe­ty.
“Con­tin­ue to build on ac­cel­er­at­ed ap­proval frame­work.” 

“Do not low­er sci­en­tif­ic stan­dards; re­tain safe­ty and ef­fi­ca­cy hur­dle; in­crease use of sur­ro­gate and re­al world end­points, in­clud­ing da­ta from wear­able and dig­i­tal sources to help stream­line ap­proval with more dis­ease- and pa­tient-rel­e­vant end­points of ef­fi­ca­cy.”

“FDA has been do­ing a good job. We need to keep the high ef­fi­ca­cy stan­dard.”

“I ac­tu­al­ly think over­all the FDA is do­ing a great job, I don’t think rad­i­cal re­form is need­ed. But I do think that many of the ini­tia­tives and re­forms of re­cent years have been em­braced by Sr. man­age­ment, but not by the rest of the bu­reau­cra­cy yet.”

“Ter­ri­fy­ing to think of low­er­ing ef­fi­ca­cy stan­dards sig­nif­i­cant­ly. Not good for the pub­lic or the in­dus­try!”

“In many ar­eas, reg­u­la­to­ry sci­ence is decades be­hind ad­vances in new tech­nolo­gies and med­ical sci­ence. In the rare dis­eases, for in­stance, we need a rig­or­ous yet flex­i­ble reg­u­la­to­ry frame­work that does not ex­ist to­day. The fact that there is not even a re­view di­vi­sion at FDA ded­i­cat­ed to rare ge­net­ic dis­eases is a tragedy in it­self. “

“In­creased use of bio­mark­ers, ac­cel­er­at­ed ap­proval path­ways and per­haps even the in­tro­duc­tion of ‘con­di­tion­al’ ap­proval path­ways will dri­ve med­i­cines that are proven safe and ef­fec­tive to pa­tients as quick­ly as pos­si­ble. In fact, the most sig­nif­i­cant change that could be made at the FDA is to in­clude the pa­tient per­spec­tive at every step of the drug de­vel­op­ment and reg­u­la­to­ry re­view process. Do­ing so will save count­less lives.”
John F. Crow­ley Chair­man & CEO Am­i­cus Ther­a­peu­tics

Brent Saun­ders’ pledge

One change that got a broad thumbs up from the E100: Brent Saun­ders’ call for an in­dus­try pledge to keep an­nu­al price in­creas­es on drugs in the sin­gle dig­its, un­der 10%. A to­tal of 67% en­dorsed the move, with quite a few call­ing it sen­si­ble and vi­able or “a breathe of fresh air.”

But there was al­so a de­tectable air of skep­ti­cism that this kind of ap­proach could work as a longterm so­lu­tion, with many see­ing it as a log­i­cal tem­po­rary step.

“This seems clos­er to fol­low­ing the laws of grav­i­ty than a plan. But it should cre­ate some much-need­ed day­light btwn in­dus­try and (con­tro­ver­sial Tur­ing founder Mar­tin) Shkre­li”

“I found Brent’s procla­ma­tion a bit disin­gen­u­ous… He pro­claims he wilre­spon­si­ble on pric­ing but then takes 9.9% across his en­tire port­fo­lio. Re­al­ly! What in­dus­try gets 9.9% price in­creas­es?”

“I would say that we should em­pha­size ty­ing price in­creas­es to in­fla­tion in some way. If in­fla­tion goes to 15% you would not raise prices by 9% and if in­fla­tion is 1% you would raise less than 9%. I wor­ry about dog­mat­ic state­ments like “sin­gle” dig­it which do not take in­to ac­count the macro eco­nom­ic is­sues.”


The pulse on biotech prospects in 2017: Run­ning strong

This is the sec­ond sur­vey that is keep­ing the thumbs on the pulse of in­dus­try con­fi­dence, which is em­phat­i­cal­ly strong. On­ly 2% of the crowd are less than some­what con­fi­dence, with three out of four run­ning the gamut of con­fi­dent to ex­treme­ly con­fi­dence.

We have 57% rat­ing the flow of in­vest­ments from VCs as ‘good.’

“The cap­i­tal is there from spe­cial­ists for the right com­pa­nies.”

“If you have a great team and a good sto­ry, you can get fund­ed.”

But not every­one is hap­py about their ac­cess to cap­i­tal these days.

“I am con­tin­u­al­ly per­plexed by the de­sire to fund “the dream” ver­sus val­i­dat­ed, re­al drugs. I wish there was more in­ter­est in re­al biotech com­pa­nies that have rev­enues and de­liv­er strong cash flows.”

IPOs are off to a so-so start af­ter a weak 2016, so it’s not too sur­pris­ing to see ex­pec­ta­tions are lim­it­ed for the rest of the year. Forty-two per­cent ranked the IPO sec­tor as fair, with 27% fair, 17% good and 14% poor. No one thought it was ex­cel­lent.

About half thought that the IPO mar­ket will stay this way for the rest of the year, with the “bet­ter” and “worse” group split 29% to 19%.


Hir­ing

Close to 4 out of 5 of these ex­ecs work in or with com­pa­nies that are hir­ing in the first quar­ter, al­so re­flect­ing a strong up­beat tem­po in terms of ex­pand­ing em­ploy­ment, which we al­so saw last fall in our first sur­vey. 86% are hir­ing this year. No one plans to re­duce staff. The biggest prob­lem cit­ed: Find­ing the right peo­ple can be dif­fi­cult.

“We’ll hire ag­gres­sive­ly again this year.”

“Job mar­ket re­mains very hot. Lots of com­pe­ti­tion to ac­cess the best tal­ent.”

“We’re hir­ing ag­gres­sive­ly but good can­di­dates are hard to find,” says Yu­val Co­hen, CEO of Cor­bus Phar­ma­ceu­ti­cals.”


Biotech val­u­a­tions: Fair to good

The pace on deals and buy­outs has start­ed off with some siz­able num­bers in biotech, but our E100 ex­ecs weren’t feel­ing gid­dy about any of it.

57% of these ex­ecs found li­cens­ing deals were be­ing done for av­er­age amounts, 37% said they were high and on­ly 5% thought of them as low. There was a split on M&A, though, with 47% rank­ing val­u­a­tions at av­er­age and 43% call­ing them out as high. That cold be a sell­ers per­spec­tive, though, as Big Phar­ma buy­ers have been say­ing for sev­er­al years now that val­u­a­tions have been run­ning ex­treme­ly high, in their view.


So where do we go from here?

“Let’s keep our eye on the prize: mak­ing im­por­tant new ther­a­peu­tics that ad­dress hu­man needs. Let us em­brace val­ue-based pric­ing. Let us shun var­i­ous his­tor­i­cal in­dus­try prac­tice to un­rea­son­ably ex­tend patent mo­nop­oly. Let us aban­don un­jus­ti­fied year-over-year cost in­creas­es in the ab­sence of proven ad­di­tion­al pa­tient ben­e­fit or con­ve­nience.”

“A good year for biotech in 2017. Too many ex­cel­lent tech­nolo­gies and in­no­va­tion . They all will find homes!”

We end with an anony­mous com­pli­ment:

“Well done, John and col­leagues. End­points is a re­fresh­ing new source for biotech- and phar­ma-re­lat­ed news and views.”

It was just 1 out of 98, but we see a trend de­vel­op­ing.

Do you have an idea for our next sur­vey? Drop me a line at john@end­pointsnews.com

  • Here’s a list of all par­tic­i­pat­ing End­points 100 ex­ec­u­tives
    Jef­frey Al­bers Blue­print Med­i­cines
    Alan Auer­bach Puma
    Stephane Ban­cel Mod­er­na
    Chuck Baum Mi­rati Ther­a­peu­tics
    John Bea­dle PsiOxus
    Kees Been Lyso­so­mal Ther­a­peu­tics
    Arie Bellde­grun Kite Phar­ma
    Nes­san Berming­ham In­tel­lia Ther­a­puet­ics
    Jean-Jacques Bi­en­aimé Bio­Marin Phar­ma­ceu­ti­cal
    Kate Bing­ham SV Life Sci­ences
    Detlev Bin­iszkiewicz Sur­face On­col­o­gy
    Kevin Bit­ter­man Po­laris Part­ners
    Robert Blum Cy­to­ki­net­ics, Inc.
    Bruce Booth At­las Ven­ture
    Ed­uar­do Bra­vo Tigenix, SAU
    Wern­er Cautreels Se­lec­ta
    Chip Clark Geno­cea Bio­sciences
    Robert Cof­fin Replimune
    Ron Co­hen Acor­da
    Yu­val Co­hen Cor­bus Phar­ma
    Robert Con­nel­ly Ax­cel­la (Pronu­tria)
    Bernard Coulie Pli­ant Ther­a­peu­tics
    John Crow­ley Am­i­cus
    David de Graaf Syn­tim­mune
    Kim Drap­kin Jounce Ther­a­peu­tics
    Cameron Dur­rant Kalo­Bios
    Glyn Ed­wards Sum­mit Ther­a­peu­tics plc
    Eliot Forster Im­muno­core
    Tas­sos Gi­anakakos MyoKar­dia
    David Giljo­hann Ex­i­cure
    Robert Gould Ful­crum Ther­a­peu­tics
    Max­ine Gowen Treve­na
    Mike Grey Am­plyx
    Geral­dine Hamil­ton Em­u­late
    John Hau­rum F-star
    Rachel Hau­r­witz Cari­bou
    Pe­ter Hecht Iron­wood
    Mary Lynne Hed­ley Tesaro
    Olav Helle­bø ReNeu­ron Group plc
    Rus­sell Hern­don Hy­dra Bio­sciences
    Rich Hey­man Hey­man Biotech
    Na­tal­ie Holles Au­dentes Ther­a­peu­tics, Inc.
    Steve Holtz­man Deci­bel Ther­a­peu­tics
    Hervé Hop­penot In­cyte
    An­nal­isa Jenk­ins Di­men­sion Ther­a­peu­tics
    Jeff Jonker NGM Bio
    Kevin Ju­dice DiCE Mol­e­cules
    Rachel King Gly­comimet­ics
    Gene Kin­ney Prothena
    Art Krieg Check­mate Phar­ma­ceu­ti­cals
    Je­re­my Levin Ovid Ther­a­peu­tics
    Howard Liang BeiGene
    Jay Lichter Aval­on Ven­tures
    John Maraganore Al­ny­lam
    Alex­ey Mar­golin Al­lena Phar­ma­ceu­ti­cals
    Tim Mayleben Es­pe­ri­on
    Sean Mc­Carthy Cy­tomX Ther­a­peu­tics
    David Mott NEA
    Lon­nie Moul­der Tesaro
    Glenn Ned­win Sec­ond Genome
    Don Nichol­son Nim­bus Ther­a­peu­tics
    Hugh O’Dowd Neon Ther­a­peu­tics
    Bernat Olle Vedan­ta
    Rick Orr Ad­ynxx
    Ju­lia Owens Mil­len­do
    An­toine Pa­piernik Sofinno­va
    Pier­lui­gi Parac­chi GENEN­TA Sci­ence
    Alexan­der Pas­teur F-Prime Cap­i­tal Part­ners
    Joe Payne Arc­turus Ther­a­peu­tics
    Michael Pelli­ni Foun­da­tion Med­i­cine
    An­drea Pfeifer AC Im­mune
    An­drew Phillips C4 Ther­a­peu­tics
    Richard Pops Alk­er­mes
    An­na Pro­topa­pas Mer­sana Ther­a­peu­tics
    Lau­rence Reid Warp Dri­ve Bio
    Nor­bert Riedel Aptinyx
    Adam Rosen­berg Rodin Ther­a­peu­tics
    Gregg San­do Cell Med­ica
    David Schenkein Agios
    Denise Scots-Knight Mereo Bio­phar­ma
    Paul Sekhri Lyc­era Corp.
    Tito Ser­afi­ni Atre­ca
    Ar­mon Sharei SQZ Ther­a­peu­tics
    Lau­ra Shawver Cleave Bio
    Clay Sie­gall Seat­tle Ge­net­ics
    Nan­cy Si­mon­ian Sy­ros Phar­ma­ceu­ti­cals
    Harpreet Singh Im­mat­ics US
    Sander Slootweg For­bion Cap­i­tal Part­ners
    Jeff Stein Cidara
    Carmine Sten­gone Ave­las Bio­sciences, Inc.
    Niclas Stiern­holm Tril­li­um Ther­a­peu­tics
    Clif­ford Stocks On­coRe­sponse
    Hamza Suria Anap­tys­Bio
    Mary Szela Aege­ri­on Phar­ma­ceu­ti­cals
    Nan­cy Thorn­ber­ry Kally­ope
    Praveen Tipir­neni Mor­phic Ther­a­peu­tic
    He­len Tor­ley Halozyme
    Dou­glas Tre­co Ra Phar­ma­ceu­ti­cals
    Steve Tre­gay For­ma Ther­a­peu­tics
    Tim Van Hauw­er­meiren Ar­genx
    Mark Vel­le­ca G1 Ther­a­peu­tics
    Greg Ver­dine Fog Phar­ma
    George Vla­suk Nav­i­tor Phar­ma­ceu­ti­cals, Inc.
    Robert Ward Ra­dius
    Ryan Watts De­nali
    Mal­colm Weir Hep­tares
    Mar­tin Welschof Op­sona Ther­a­peu­tics Ltd
    Doug Williams Co­di­ak
    Troy Wil­son Ku­ra On­col­o­gy
    Steve Yang WuXi AppTec

Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.
The biotech started by putting together an “arsenal” of technologies aimed at making cell therapies for cancer much, much better than the rather crude first-generation drugs that hit the market from Novartis and Kite.
Their drugs have become the baseline against which all others are being measured.
“The technology set we’re developing is independent of the chassis,” Drazan tells me. “It doesn’t have to be autologous (extracted from the patient) or allogeneic (off the shelf). It doesn’t have to be a T cell, it could be a B cell.” But they are starting out on the autologous side, where they have the most knowledge and insight into manufacturing techniques.
It also doesn’t have to be close to the clinic.
Drazan expects the biotech will be working its way through preclinical operations for “a few years,” with enough money from the $85 million launch round to get into humans.
By today’s superheated fundraising standards, that’s not a huge amount of cash. Lyell, another cell therapy 2.0 startup we featured last week, raised $600 million in a year, including a big chunk of cash from GlaxoSmithKline. Drazan is interested in dealmaking as well, but he also knows he has the cash necessary to support the company for a good run — a key part of what it takes to bring together a stellar team of top players.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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UCB tries to win some re­spect in the crowd­ed pso­ri­a­sis mar­ket with a dual IL-17 ap­proach — and it won't be easy

For a pharma company with about $5 billion in revenue, a couple of respectably sized blockbuster drugs on the market and some high-profile partners like Amgen, Belgium’s UCB has kept an unusually low profile on the pipeline side of things over the years.
Until now.
Just days after striking a $2.1 billion deal to buy Ra Pharmaceuticals and its C5 rival to Soliris, UCB is posting positive top-line Phase III results for a dual IL-17 inhibitor that it’s steering into one of the most competitive commercial spaces in the industry. And despite plenty of obvious challenges as they struggle to roll out Evenity with Amgen and patent expirations loom on its franchise drugs, including Cimzia, the company just may be ready to tackle some of the biggest players on the planet.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.
We don’t know the PASI90 and IGA scores — but UCB knows that with the kind of heavyweight competition it faces with Novartis and others, marginal gains for patients won’t stack up. So we’ll be watching for the hard numbers. And there’s another head-to-head with Cosentyx that will play a big role in pushing up analysts’ projections on peak sales, which currently fall well short of blockbuster status.
UCB hasn’t exactly been in the spotlight for the last few years, but it’s in a position now that the company has to win some respect in R&D, with blockbuster projects that can keep investors’ attention at a time the industry is experiencing booming R&D development efforts around the planet.
It hasn’t been easy. There was a setback on a lupus drug partnered with Biogen. But there have been some advances, with a deal to buy Proximagen’s NDA-ready nasal spray therapy USL261, designed as a rescue therapy for acute repetitive seizures, for $150 million in cash and another $220 million in sales and regulatory milestones. There was even a report that the company was kicking the deflated tires at Acorda, though nothing came of that.
Late last year UCB also committed to spend up to £200 million on a new R&D hub in the UK.
That may not translate into a lot of excitement right now, but they’re trying. And there’s a subtle promise that more deals may be in the works.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Swamy Vijayan. Plexium

San Diego up­start de­buts dis­cov­ery en­gine that puts a twist to pro­tein degra­da­tion

For years, the idea of protein degradation — utilizing the cell’s natural garbage disposal system to mark problematic proteins for destruction — remained an elegant but technically difficult concept. But now established as a promising clinical strategy, with major biopharma players such as Bayer, Gilead and Vertex trying to grab a foothold via partnership deals, a San Diego startup is looking to exploit it and push its limits.

CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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