Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to over­turn a ju­ry ver­dict that or­dered it to pay Bris­tol My­ers Squibb about $752 mil­lion for CAR-T patents owned by its sub­sidiary Juno Ther­a­peu­tics has end­ed in vain.

The rul­ing leaves Gilead vul­ner­a­ble to an even big­ger $1.5 bil­lion pay­ment that Bris­tol is now de­mand­ing — adding fu­el to the fiery crit­i­cism some an­a­lysts are al­ready heap­ing on its $11.9 bil­lion Kite buy­out.

In a 30-page doc­u­ment un­sealed on Mon­day, Judge James Otero of the dis­trict court in Los An­ge­les struck down sev­er­al dif­fer­ent ar­gu­ments for a new de­ci­sion. Here are Mor­gan Stan­ley an­a­lysts’ take­aways:

The court, in par­tic­u­lar, de­nied Kite’s con­tentions (1) that Juno’s patent is in­valid, (2) the dam­ages award was un­rea­son­able, and (3) that a new tri­al should take place. The court al­so de­nied Kite’s ar­gu­ment that its in­fringe­ment was not will­ful.

Gilead is like­ly to ap­peal to the fed­er­al cir­cuit, they not­ed, but the odds are not in their fa­vor as the same stan­dard for ev­i­dence will be ap­plied in that court. Ap­peals typ­i­cal­ly take 16 months.

Be­fore that, the low­er court is due to rule on Juno’s own post-tri­al mo­tion to dou­ble the dam­ages from $585 mil­lion to $1.5 bil­lion, and raise the run­ning roy­al­ty rate payable to Bris­tol My­ers from 27.6% to 33.1%.

The num­bers are as­tro­nom­i­cal on their own, but es­pe­cial­ly so con­sid­er­ing that Yescar­ta has on­ly earned $456 mil­lion in sales last year — which is al­ready a jump from $264 mil­lion in 2018. Gilead will have to pay roy­al­ties un­til Juno’s patents ex­pire in Au­gust 2024, which “makes Yescar­ta po­ten­tial­ly a neg­a­tive-mar­gin busi­ness.”

It is yet un­clear whether, or how much, the patent is­sues will af­fect the oth­er CAR-T prod­ucts in Kite’s pipeline. Un­der CEO Kristi Shaw, the group has scored pri­or­i­ty re­view for a sec­ond CAR-T dubbed KTE-X19.

At the crux of the dis­pute is the claim that Steve Rosen­berg of the Na­tion­al Can­cer In­sti­tute copied MSK in­ves­ti­ga­tor Michel Sade­lain’s CAR back­bone in cre­at­ing the CD19-tar­get­ing con­struct that he lat­er li­censed to Kite.

Dur­ing the pro­ceed­ings the in­ter­ac­tion be­tween Arie Bellde­grun, who co-found­ed Kite and has since moved on­to pi­o­neer­ing al­lo­gene­ic CAR-T ther­a­pies, and Memo­r­i­al Sloan Ket­ter­ing ex­ecs were thrust in­to the spot­light. The court again high­light­ed those episodes as part of the “suf­fi­cient ev­i­dence of will­ful­ness.”

Plain­tiff’s fact wit­ness Dr. Dash tes­ti­fied that Dr. Bellde­grun was so des­per­ate to pur­sue a li­cense to the ‘190 Patent that he ap­peared at her of­fice, de­spite not hav­ing a meet­ing. Dr. Jakobovitz sim­i­lar­ly tes­ti­fied that Dr. Bellde­grun met with Plain­tiffs in an at­tempt to li­cense the ‘190 Patent. Plain­tiffs fur­ther ar­gued that De­fen­dant’s fil­ing of the IPR against the ‘190 Patent demon­strat­ed the im­por­tance of the ‘190 Patent to De­fen­dant.

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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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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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.

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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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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Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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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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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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