Div­ing deep in­to CAR-T, Gilead forges $12B buy­out deal for Kite Phar­ma

Gilead has forged the big, trans­for­ma­tion­al buy­out deal that every­one in the in­dus­try has been wait­ing for.

Gilead $GILD has agreed to buy CAR-T pi­o­neer Kite Phar­ma $KITE — which is like­ly just months away from its first ap­proval — for $11.9 bil­lion in cash.

The buy­out will in­stant­ly make Gilead a leader in adop­tive cell ther­a­py, go­ing head-to-head against No­var­tis’ lead­ing ef­fort with CTL019. And in a call with an­a­lysts ear­ly Mon­day, Gilead ex­ecs un­der­scored that while cell ther­a­pies would be­come the cor­ner­stone of their work in on­col­o­gy, the busi­ness de­vel­op­ment team is pur­su­ing more pacts to build that seg­ment of the pipeline.

Gilead agreed to forge the deal at a price of $180 a share, a rel­a­tive­ly mod­est 29% pre­mi­um of the com­pa­ny’s al­ready swollen share price. Just three years ago, though, Kite went pub­lic with an IPO that ini­tial­ly priced at $17 a share. The buy­out price rep­re­sents a 960% in­crease on that.

The biggest sin­gle ben­e­fi­cia­ry of the buy­out will be Kite CEO Arie Bellde­grun, whose 5.9% stake in Kite — list­ed in the lat­est avail­able proxy state­ment — is to­day worth $597,706,380.

Arie Bellde­grun

Kite’s lead­ing drug is axi-cel, which comes with a peak sales es­ti­mate hov­er­ing close to $2 bil­lion a year. But the com­pa­ny has al­so been ac­tive­ly work­ing on a slate of next-gen can­cer ther­a­pies that promise to move be­yond the ini­tial re-en­gi­neer­ing work with chimeric anti­gen re­cep­tors in an ef­fort to move be­yond blood can­cers and in­to sol­id tu­mors.

For Gilead, it’s a chance to forge a new busi­ness that can be re­li­ably lined up next to its foun­da­tion­al work in HIV, where it con­tin­ues to be an in­dus­try leader. Gilead paid $11 bil­lion for Phar­mas­set to break in­to the hep C mar­ket. The com­pa­ny ac­com­plished that task with fly­ing col­ors, but af­ter watch­ing sales swell in­to megablock­buster ter­ri­to­ry, rev­enue has peaked and is ex­pect­ed to slide in com­ing years.

That com­bi­na­tion of fi­nan­cial fire­pow­er — Gilead can eas­i­ly fund this deal re­ly­ing on its cash re­serves — and a need to build the busi­ness put Gilead in a per­fect spot to ac­quire Kite just as the biotech neared a ma­jor cross­road.

For Kite CEO Bellde­grun, the buy­out marks the end of a ma­jor dri­ve to cre­ate a com­pa­ny that could de­vel­op and mar­ket a per­son­al­ized cell ther­a­py. Kite has worked close­ly with the NCI’s Steven Rosen­berg, the sci­en­tist who helped pi­o­neer CAR-T ther­a­pies.

This ac­qui­si­tion al­so has some im­pli­ca­tions for the in­dus­try. M&A has been lack­ing so far in 2017, with big play­ers like Pfiz­er hold­ing back in an­tic­i­pa­tion of tax re­form leg­is­la­tion that would al­low them to move bil­lions from over­seas ac­counts. Gilead CEO Mil­li­gan, though, has con­sis­tent­ly main­tained that to run a bio­phar­ma com­pa­ny prop­er­ly, you need to ig­nore what’s go­ing on in Wash­ing­ton and make de­ci­sions. He may in­spire oth­ers to fol­low suit, oil­ing the tracks on more deals.

John Mil­li­gan, Gilead CEO

“The ac­qui­si­tion of Kite es­tab­lish­es Gilead as a leader in cel­lu­lar ther­a­py and pro­vides a foun­da­tion from which to dri­ve con­tin­ued in­no­va­tion for peo­ple with ad­vanced can­cers,” said John Mil­li­gan, Gilead’s pres­i­dent and CEO. “The field of cell ther­a­py has ad­vanced very quick­ly, to the point where the sci­ence and tech­nol­o­gy have opened a clear path to­ward a po­ten­tial cure for pa­tients. We are great­ly im­pressed with the Kite team and what they have ac­com­plished, and share their be­lief that cell ther­a­py will be the cor­ner­stone of treat­ing can­cer. Our sim­i­lar cul­tures and his­to­ries of dri­ving rapid in­no­va­tion in or­der to bring more ef­fec­tive and safer prod­ucts to as many pa­tients as pos­si­ble make this an ex­cel­lent strate­gic fit.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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