Dear Kite: With 2300% up­side, we blazed an amaz­ing trail

With the $12 bil­lion Kite buy­out now signed, sealed and de­liv­ered, CEO Arie Bellde­grun has penned a thank-you note to every­one who helped along the way.

Here it is, in its en­tire­ty.


To My Kite Fam­i­ly –

Arie Bellde­grun

For all of us, the Kite ex­pe­ri­ence has been more than just an in­vest­ment op­por­tu­ni­ty or a step­ping stone in a pro­fes­sion­al ca­reer. Over the past eight years, Kite has be­come an in­te­gral part of our lives and a foun­da­tion from which hope be­came more than just an as­pi­ra­tion.

To our pa­tients: You put your faith in us and an ex­per­i­men­tal tech­nol­o­gy known as CAR T ther­a­py. That faith al­lowed a small proof-of-con­cept tri­al to po­ten­tial­ly pro­duce the first-and-on­ly ap­proved CAR T ther­a­py for mul­ti­ple forms of large B-cell lym­phoma. We now have the po­ten­tial to treat thou­sands of pa­tients in need and the means to ex­pand the tech­nol­o­gy to treat many oth­er tu­mors.

To clin­i­cians, our stead­fast part­ners: Your tire­less ef­forts in con­duct­ing clin­i­cal tri­als, with the sole pur­pose of giv­ing your pa­tients hope when no oth­er op­tions re­mained, is to be com­mend­ed. You should be proud. Your de­ter­mi­na­tion and ex­per­tise have paved the way for oth­ers to fol­low.

To our in­vestors: I am hon­ored and hum­bled by your con­tin­ued be­lief in us. Some of you joined me in the nascent stages of Kite, where you in­vest­ed in sim­ply my word, pas­sion and be­lief. While oth­er in­vestors came lat­er, all of you stood by our side, time and time again, even when oth­ers tried to in­fuse doubt. You have been wise ad­vi­sors and fierce sen­tinels.

To our Board of Di­rec­tors: Your sup­port and guid­ance is be­yond what any­one may read in an SEC fil­ing. You have been our guardians and teach­ers, each bring­ing your own set of ex­pe­ri­ences and in­sights for the bet­ter­ment of every­one in­volved in Kite. You have helped us build and pre­serve a bright fu­ture for cell ther­a­py.

To our UCLA friends and Sci­en­tif­ic Founders: Back in 2009, your un­pop­u­lar be­lief that cel­lu­lar im­munother­a­py not on­ly held great promise for the treat­ment of pa­tients but could al­so be brought to pa­tients with oth­er­wise in­cur­able can­cer was para­mount to the suc­cess of Kite. Your friend­ship, ex­per­tise and sup­port of the en­tire Kite fam­i­ly for the past eight years is the ul­ti­mate ex­am­ple of a suc­cess­ful aca­d­e­m­ic-in­dus­try part­ner­ship. I can­not thank you enough for all you have done for Kite.

To our em­ploy­ees: I can’t imag­ine work­ing along­side a braver, more pas­sion­ate or more com­mit­ted group of peo­ple, of­ten­times at the qui­et sac­ri­fice of your per­son­al lives. Your de­vo­tion has been with­out lim­it or ques­tion, even in the face of skep­tics.

In a span of just a few short years, we grew from few­er than 10 em­ploy­ees to al­most 700. The com­pa­ny’s val­ue in­creased 2300% from the time of our IPO to near­ly $12 bil­lion with the ac­qui­si­tion by Gilead Sci­ences. Our clos­ing $180 per share price rep­re­sents not just a 960% ap­pre­ci­a­tion from the IPO price of $17 per share, but the largest ever pre-com­mer­cial bio­phar­ma ac­qui­si­tion.

Kite has changed so many lives in just eight years. I know it has changed mine. I hope it has changed yours, too.

In this, my last of­fi­cial up­date as Pres­i­dent and CEO of Kite, I re­main filled with hope. Hope that Kite’s maid­en flight is mere­ly the first leg of a jour­ney, with an ul­ti­mate des­ti­na­tion more amaz­ing than any of us can to­day con­ceive. Hope that we, in­di­vid­u­al­ly, and col­lec­tive­ly, re­main fo­cused on the cure and con­tin­ue to work to­ward this no­ble pur­suit. And, hope that I get the chance to shake your hand and per­son­al­ly thank each of you for what you have done to make the Kite dream pos­si­ble.

Hope is on­ly the be­gin­ning, not the strat­e­gy.

Thank you all again for your years of sup­port. None of this would have been pos­si­ble with­out each of you.

Arie

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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