Gilead gets in on the mi­cro­bio­me game with a $38M pact, up to $1.5B in mile­stones

In what had been shap­ing up to be a ma­jor year for mi­cro­bio­me biotechs, Gilead is get­ting in on the ac­tion.

Amer­i­ca’s new­ly most watched big biotech an­nounced a four-year, $38 mil­lion up­front pact with Sec­ond Genome to iden­ti­fy bio­mark­ers that can mea­sure clin­i­cal re­sponse to Gilead’s in­flam­ma­tion and fi­bro­sis drugs, among oth­ers, and to find up to 5 new in­flam­ma­to­ry bow­el dis­ease tar­gets or drug can­di­dates. If all five of those can­di­dates reach mar­ket — a rather un­like­ly oc­cur­rence — the deal could be worth up to $1.5 bil­lion.

The pact comes as the mi­cro­bio­me field — the study of the tril­lions of bac­te­ria in the gut, their role in dis­ease, and their po­ten­tial as both drugs and drug tar­gets — awaits some of its first large read­outs since 2016, when a ma­jor fail­ure in a tri­al to treat C. diff in­fec­tion cur­tailed the field. Seres, Finch and Re­bi­otix are all ex­pect­ed to read­out for new C. diff tri­als lat­er this year.

The bac­te­r­i­al in­fec­tion is a first step, but the field broad­ly hopes to even­tu­al­ly ex­pand in­to the in­flam­ma­to­ry bow­el dis­eases cov­ered in the Gilead pact. All three of those biotechs al­so have ear­li­er stage pro­grams for IBD dis­eases such as ul­cer­a­tive col­i­tis or Crohn’s dis­ease, and Sec­ond Genome has one in the “dis­cov­ery” phase.

The con­nec­tion be­tween the mi­cro­bio­me and IBD or oth­er in­flam­ma­to­ry dis­eases is not ful­ly un­der­stood, but a large group has linked changes in gut bac­te­ria to the dis­ease. One the­o­ry is that these changes in the mi­cro­bio­me lead to bac­te­ria ac­tu­al­ly tear­ing through the bar­ri­er lin­ing of the in­tes­tine, al­low­ing bac­te­ria to leak out in­to the mus­cles and trig­ger­ing an im­mune re­sponse. Change the bac­te­ria, some biotechs think, and fix the lin­ing.

Al­though Big Phar­ma has not em­braced the mi­cro­bio­me with the same vig­or they have oth­er emer­gent fields, this is far from the first such deal. J&J and Bris­tol My­ers Squibb signed sim­i­lar bio­mark­er dis­cov­ery pacts with mi­cro­bio­me biotechs in 2018 and 2016.

Gilead is not new to the IBD field. Their JAK-1 in­hibitor fil­go­tinib is ex­pect­ed to be ap­proved this year and even­tu­al­ly be­come a block­buster. They al­so have a se­ries of ear­li­er stage can­di­dates for in­flam­ma­to­ry dis­ease, de­vel­oped both in house and with their part­ner Gala­pa­gos. The Cal­i­for­nia-based drug­mak­er rose to pub­lic and fi­nan­cial promi­nence build­ing an­tivi­ral drugs for life-threat­en­ing in­fec­tions — a role that has be­come acute amid the Covid-19 pan­dem­ic — but they have in re­cent years in­vest­ed bil­lions to ex­pand their ar­se­nal.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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

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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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' 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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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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