GSK bags Tesaro for $5B as it leaps back in­to com­mer­cial on­col­o­gy and beefs up can­cer drug pipeline

Glax­o­SmithK­line has struck a deal to buy Tesaro $TSRO in a $5.1 bil­lion deal that will vault the phar­ma gi­ant in­to the com­mer­cial on­col­o­gy mar­ket as it stakes out a big new role for it­self in the boom­ing can­cer field.

Long dis­cussed af­ter Tesaro man­age­ment put out the word on sev­er­al oc­ca­sions in the past year that it was look­ing to sell the com­pa­ny and its PARP in­hibitor Ze­ju­la, GSK is pay­ing $75 a share, trig­ger­ing an in­stant 60% spike in the stock this morn­ing as in­vestors caught up to the news to­day.

Wait­ing out the ear­ly buzz al­lowed GSK to pick this com­pa­ny up for a rel­a­tive bar­gain. Tesaro start­ed 2018 at $82 a share, but watched its share price slide 42% un­til to­day as an­a­lysts beat them up over their poor sales per­for­mance. In ear­ly 2017, the stock hit a high of $190. That helps ex­plain why Tesaro was nev­er able to suc­ceed at auc­tion­ing the com­pa­ny ear­li­er, when its share price was still in­flat­ed.

Ze­ju­la is one of sev­er­al PARPs to hit the mar­ket af­ter As­traZeneca pi­o­neered the field with the first ap­proval for Lyn­parza, though lit­tle Tesaro has strug­gled to play catch-up along­side Clo­vis and Pfiz­er, which won a re­cent ap­proval for its PARP, ob­tained in the Medi­va­tion buy­out.

It won’t be easy. As­traZeneca and its new part­ners at Mer­ck have poured re­sources in­to the Lyn­parza fran­chise, win­ning block­buster re­turns as they widen their lead over the pack. And the ac­qui­si­tion wasn’t ex­act­ly cheered by GSK in­vestors, who drove the stock down a painful 8% af­ter the news hit.

The ac­qui­si­tion, though, gives Hal Bar­ron’s resur­gent can­cer re­search group un­der Ax­el Hoos a new drug to work with, as GSK pur­sues new in­di­ca­tions in a range of clin­i­cal tri­als aimed at ex­pand­ing its mar­ket pres­ence in on­col­o­gy.

GSK is just now jump­ing back in­to the com­mer­cial can­cer field af­ter strik­ing a deal with No­var­tis to flip its late-stage and mar­ket­ed on­col­o­gy prod­ucts for a port­fo­lio of vac­cines.

The move comes about a year af­ter Bar­ron — who had a leg­endary run at Genen­tech — took the top R&D job at GSK. As he told me ear­li­er this year, his new team — in­clud­ing new BD chief Kevin Sin — was hard at it scour­ing the globe for deals that made sense for the com­pa­ny.

At this point, a weary Tesaro and Ze­ju­la looked un­der­val­ued. And that made it a prime tar­get for the phar­ma com­pa­ny. GSK has been a ma­jor play­er in HIV and vac­cines, but its phar­ma R&D ops are the weak­est in its heavy­weight class.

This new deal brings a pipeline that al­so adds a PD-1 — one in a tidal wave of check­points — as well as TIM-3 and LAG-3 as­sets, which are al­so not so un­com­mon. In the mean­time, Bar­ron made it clear in a call with re­porters this morn­ing that he was ea­ger to see about the po­ten­tial to ex­pand Ze­ju­la in­to the broad­er HRD-pos­i­tive com­mu­ni­ty, which would dra­mat­i­cal­ly in­crease the size of the mar­ket.

PARPs work by in­ter­fer­ing with DNA re­pair mech­a­nisms that al­low can­cer cells to sur­vive, open­ing up an av­enue that could re­late to a va­ri­ety of can­cers.

So what hap­pens to the 800 or so staffers at Tesaro? 

Em­ma Walm­s­ley

In a call with re­porters Mon­day morn­ing, CEO Em­ma Walm­s­ley not­ed that the deal wasn’t be­ing dri­ven by cost syn­er­gies and al­so brings com­mer­cial ca­pa­bil­i­ties back to a com­pa­ny that cur­rent­ly doesn’t have an on­col­o­gy sales force. In time, she added, they’ll look at syn­er­gies — code for cuts — but it’s ear­ly days on that.

Walm­s­ley al­so de­clined to say just what kind of peak sales they can ex­pect from Ze­ju­la. In the past, though, peak sales es­ti­mates have climbed to $2 bil­lion.

“Our strong be­lief is that PARP in­hibitors are im­por­tant med­i­cines that have been un­der ap­pre­ci­at­ed in terms of the im­pact they can have on can­cer pa­tients,” Bar­ron not­ed in a state­ment. “We are op­ti­mistic that Ze­ju­la will demon­strate ben­e­fit in pa­tients with ovar­i­an can­cer be­yond those who are BR­CA-pos­i­tive as front-line treat­ment. We are al­so very ex­cit­ed that through this trans­ac­tion, we will have the op­por­tu­ni­ty to work with an out­stand­ing Boston-based on­col­o­gy group with deep clin­i­cal de­vel­op­ment ex­per­tise and to­geth­er we will ex­plore Ze­ju­la’s ef­fi­ca­cy be­yond ovar­i­an can­cer in­to mul­ti­ple tu­mour types to help many more pa­tients.”


Im­age: Ax­el Hoos, Hal Bar­ron, John Lep­ore, Kevin Sin and Tony Wood.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

Sanofi’s big week in­cludes a promis­ing PhI­II for an or­phan dis­ease drug, with plans for a pitch to the FDA

The biopharma R&D food chain is paying off with a plan at Sanofi to pitch regulators on a new drug for an orphan disease called cold agglutinin disease.

The pharma giant ushered out a statement Tuesday morning — after it spelled out plans to radically restructure the company, abandoning cardio and diabetes research altogether — saying that their C1s inhibitor sutimlimab had cleared the pivotal study.