Gilead, Gala­pa­gos re­port com­pet­i­tive num­bers for first big PhI­II read­out for fil­go­tinib in rheuma­toid arthri­tis

Gilead $GILD and its part­ners at Gala­pa­gos $GLPG of­fered their first cut of Phase III da­ta for fil­go­tinib, their late-stage can­di­date for dis­rupt­ing the rheuma­toid arthri­tis mar­ket. And while they may have come in nu­mer­i­cal­ly a lit­tle be­hind their big ri­val at Ab­b­Vie, re­searchers seem to have gained a good safe­ty pro­file and some com­pet­i­tive num­bers that help jus­ti­fy Gilead’s $725 mil­lion up­front near­ly 3 years ago.

John McHutchi­son

Look­ing at a snap­shot of the da­ta, 100 mg fil­go­tinib hit a 57.5% mark for ACR20 at 12 weeks and 66% for 200 mg. At the 24 week mark, that trans­lat­ed to 54.9% and 69.4%. The clin­i­cal re­mis­sion rate was 25.5% and 22.4% at 12 weeks, 26.1% and 30.6% at 24 weeks.

That was all much bet­ter than the place­bo arms in this study — hit­ting the pri­ma­ry and the key sec­on­daries in sight. Fil­go­tinib, though, is the drug that Ab­b­Vie $AB­BV aban­doned to stick with upadac­i­tinib (ABT-494), which in one Phase III hit with 71% of pa­tients achiev­ing ACR20 and 29% achiev­ing clin­i­cal re­mis­sion at week 12.

Gilead’s shares jumped 2.3% on the news in af­ter-mar­ket trad­ing while Gala­pa­gos saw its stick surge 18% on Wednes­day.

This isn’t a head-to-head study, of course, but these days it may as well be. 

Upadac­i­tinib, like oth­er JAK in­hibitors such as Eli Lil­ly’s baric­i­tinib, has had some safe­ty is­sues to con­tend with. In this study of fil­go­tinib, the com­pa­nies gave them­selves high marks on safe­ty, with no tri­al deaths to re­port; 3.4, 5.2 and 4.1% of the pa­tients in the place­bo, 100mg and 200mg groups re­port­ing a se­ri­ous ad­verse event. There was “one case of non-se­ri­ous reti­nal vein oc­clu­sion in the fil­go­tinib 200 mg group and no re­ports of deep ve­nous throm­bo­sis or pul­monary em­bolism.”

There were two big MACE events, but they were split be­tween the drug and place­bo arms.

Leerink’s Ge­of­frey Porges sized up the press re­lease and says this one could be a game chang­er, with an im­proved 80% chance of suc­cess at the FDA.

At least based on the com­pa­nies’ press re­lease last night, this hy­poth­e­sis is in­deed valid and sup­ports the no­tion that while fil­go­tinib may not be the first of these drugs to mar­ket (like­ly the last), it might be the best.

Jef­feries’ Michael Yee was quick to re­mark:

The good news is this is the first pos­i­tive study and helps to de-risk the ini­tial read­outs for the fran­chise and looks pret­ty clean. We see this as a mod­est but good cat­a­lyst for GILD giv­en re­cent stock per­for­mance over the last few months and some frus­trat­ed in­vestor sen­ti­ment. The next ma­jor read­outs are in H1:19, al­though the key big­ger pic­ture read­out that Street will want to know in time is the Phase II/III UC male tox­i­c­i­ty study which is still en­rolling, and GILD is work­ing hard to ac­cel­er­ate en­roll­ment which may in­clude open­ing it up to oth­er in­di­ca­tions and lots more sites.

“These ini­tial Phase III da­ta sup­port the po­ten­tial of fil­go­tinib, in com­bi­na­tion with se­lect dis­ease mod­i­fy­ing drugs, to help pa­tients with ac­tive rheuma­toid arthri­tis who do not ad­e­quate­ly re­spond to cur­rent bi­o­log­ic dis­ease mod­i­fy­ing agents,” says Gilead CSO John McHutchi­son. “These da­ta are par­tic­u­lar­ly en­cour­ag­ing as we look ahead to Phase 3 re­sults from the on­go­ing FINCH 1 and 3 tri­als, which are ex­plor­ing fil­go­tinib in oth­er pop­u­la­tions of pa­tients with rheuma­toid arthri­tis.”

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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