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.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

An­oth­er four biotechs scratch out the first num­ber and ask for more as IPO boom con­tin­ues

Four more biotechs are raising their offers in an already record year for biotech IPOs.

Softbank-backed Relay Therapeutics scratched out its original $200 million filing and proposed a $250 million raise that would make them a $1.5 billion company. CAR-T developer Poseida Therapeutics bumped itself up $74 million to $224 million. Off-the-shelf cell therapy startup Nkarta upped from $150 million to $215 million — and then priced even higher, at $252 million. France’s Inventiva did its own modest reset, raising its bar from $102 million to $108 million.

Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.