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 Younatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application.

The big biotech also notes that the “FDA has stated that, if possible, it plans to act early on this application under an expedited review.”

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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