Arie Bellde­grun and David Chang score record IPO, now they plan to win the race to a his­toric FDA OK

Arie Bellde­grun and David Chang are once again in the race of a life­time — and they plan to stay in the lead to the first pi­o­neer­ing FDA OK in the field.

The two ex-Kite ex­ecs have pulled off the biggest biotech IPO of their gen­er­a­tion, up­siz­ing the of­fer­ing to 18 mil­lion shares and pric­ing at $18 a share — the top of the range.

Arie Bellde­grun

The Al­lo­gene of­fer­ing brought in $324 mil­lion, peg­ging the mar­ket val­ue of the com­pa­ny at $2.2 bil­lion, and un­der­writ­ers will soon have a chance to boost that some more. That sum edges out Ax­o­vant, which raised $315 mil­lion in 2015 to back an Alzheimer’s drug that turned out to be a com­plete bust.

“So far I have not seen a com­pa­ny that is all about al­lo­gene­ic,” Bellde­grun tells me in a phone in­ter­view, dis­cussing the off-the-shelf ap­proach to CAR-T they scooped up from Pfiz­er. “This is a huge op­por­tu­ni­ty.”

“We want to be in the lead,” he adds.

To do that, Al­lo­gene can now re­ly on a war chest filled with the bulk of the mon­ey raised in a mon­ster, $744 mil­lion fundrais­ing blitz through the year.

The next big tran­si­tion point comes in the first half next year, when they go in­to the clin­ic with their lead ther­a­py. If they stay on sched­ule — fol­low­ing an al­ways haz­ardous course of clin­i­cal de­vel­op­ment — Chang says they could grab piv­otal da­ta by the end of 2021. In the mean­time, they’ll al­so ush­er in an­oth­er clin­i­cal pro­gram in 2019, with an­oth­er ther­a­py that could pur­sue mul­ti­ple in­di­ca­tions in on­col­o­gy.

The pair have been there be­fore, rac­ing No­var­tis on per­son­al­ized CAR-T ther­a­pies. The phar­ma gi­ant just bare­ly edged them out. But that was a tech­nol­o­gy that was 15 years in the mak­ing, says Bellde­grun. Now they have a host of new tools, like gene edit­ing, at their dis­pos­al. And by carv­ing out a Pfiz­er group with 40 core staffers and a 4-year track record in pre­clin­i­cal work, they plan to make rel­a­tive­ly quick work of this new race.

We’ll see lat­er to­day how in­vestors like the lat­est biotech uni­corn to hit the Nas­daq, where Bellde­grun and Chang made their mark with Kite Phar­ma — which sold to Gilead for $12 bil­lion, mak­ing in­vestors a bit gid­dy.

David Chang

Over the last 6 months they’ve raised $744 mil­lion for the com­pa­ny in the wake of in-li­cens­ing Pfiz­er’s off-the-shelf CAR-T port­fo­lio, a fig­ure that would have been con­sid­ered some­thing of a pipe dream be­fore 2018 came around.

Now that the mon­ey blitz is done, open­ing up a 3-year run­way to an ap­point­ment with the FDA, the com­pa­ny will con­tin­ue a quest to de­vel­op the world’s first off-the-shelf CAR-T, a sci­en­tif­ic chal­lenge that could swipe aside the pi­o­neer­ing per­son­al­ized drugs that are now on the mar­ket at No­var­tis and Gilead.

They’ve al­ready dou­bled the size of the orig­i­nal team, and more hires are to come. Al­lo­gene al­so has some am­bi­tious plans to es­tab­lish a lead­ing man­u­fac­tur­ing ef­fort, which will be key to their ul­ti­mate suc­cess in the field.

Gold­man Sachs & Co, J.P. Mor­gan Se­cu­ri­ties, Cowen and Com­pa­ny, and Jef­feries are act­ing as the joint book-run­ning man­agers for the of­fer­ing. 

This year we’ve seen a rapid surge in new biotech IPOs, which was large­ly un­ex­pect­ed af­ter a cou­ple years of steady run­ning. And once again Bellde­grun and Chang have their tim­ing down per­fect­ly. In­evitably, a deal like this will raise ques­tions about just how hot things are on the Nas­daq right now, and whether we’re in a bub­ble.

But it’s not over yet.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.

While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.

Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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