Mark Alles. Celgene

Mark Alles be­gins his post-Cel­gene ca­reer on the board of a US-Chi­na biotech led by a for­mer col­league

An­ten­gene had Cel­gene writ­ten all over its brand. Its founder and CEO, Jay Mei, was the big biotech’s ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment in hema­tol­ogy/on­col­o­gy for eight years be­fore launch­ing his own start­up in Chi­na with his for­mer em­ploy­er as a part­ner and in­vestor. Cel­gene chipped in­to An­ten­gene’s $120 mil­lion round last year, and just days ago, it al­so wooed Cel­gene’s Chi­na gen­er­al man­ag­er to be its chief busi­ness of­fi­cer.

You can add one more promi­nent il­lus­tra­tion to the list. In one of his first moves since sell­ing Cel­gene to Bris­tol-My­ers Squibb for $74 bil­lion, for­mer CEO Mark Alles is join­ing An­ten­gene’s board of di­rec­tors.

“Mark brings out­stand­ing gov­er­nance and com­mer­cial ex­pe­ri­ence that will help pro­mote our de­vel­op­ment and com­mer­cial strat­e­gy in Chi­na, the Asia Pa­cif­ic re­gions and the rest of the world,” Mei said in a state­ment.

While he was still work­ing for the New Jer­sey biotech, Mei had ac­com­pa­nied Alles on a trip to Bei­jing to meet with John Oyler re­gard­ing an as­set swap deal that would see BeiGene mar­ket­ing some of Cel­gene’s can­cer drugs in Chi­na, in ex­change for a made-in-Chi­na PD-1 (which they even­tu­al­ly dropped). In fact, he re­calls the ex­act date they met: May 14, 2016.

Jay Mei (End­points/Pharm­Cube)

Click on the im­age to see the full-sized ver­sion

That part­ner­ship ce­ment­ed BeiGene’s sta­tus as a pi­o­neer­ing US-Chi­na biotech act­ing as a bridge be­tween Amer­i­can in­no­va­tion and the vast Chi­nese mar­ket, con­tribut­ing their share of R&D work along the way. Mei counts An­ten­gene, based in Shang­hai and Philadel­phia, as a mem­ber of this camp — con­sist­ing of hy­brids that work like a multi­na­tion­al drug­mak­er but un­der­stand the do­mes­tic mar­ket deeply.

“In fact I of­ten say Chi­na is a coun­try with three worlds,” he told re­porters at the End­points-Pharm­Cube BI­IS con­fer­ence in late 2018. “[Shang­hai] is in the heart of the first world; you dri­ve an hour or two and it might be the sec­ond world; dri­ve three to four hours and you ar­rive at the third world. Chi­na is very com­plex.”

But the coun­try has gone a long way in em­brac­ing emerg­ing biotechs from over­seas — speed­ing up reg­u­la­to­ry process­es and ap­provals dras­ti­cal­ly — as well as nur­tur­ing its own.

“Ten years ago when I first came to Chi­na to in­tro­duce Cel­gene’s prod­ucts, the ex­perts had heard of our drugs be­cause they’d been to ASH and AS­CO,” Mei re­called. “But no­body had heard of the com­pa­ny.”

Thanks in part to Alles’ busi­ness de­vel­op­ment strate­gies, that is no longer the case. And the in­dus­try vet, who’s al­so tak­en a board role at Sy­ros, said he’s now ex­cit­ed to bring all that ex­pe­ri­ence to An­ten­gene now that it’s ever clos­er to com­mer­cial­iza­tion.

The first an­tic­i­pat­ed launch would be of se­linex­or, or ATG-010, a con­tro­ver­sial mul­ti­ple myelo­ma drug li­censed from Karyopharm. Al­so work­ing to­ward that goal is new CBO John Chin, who spent 15 years with Cel­gene and was cred­it­ed for man­ag­ing the Revlim­id fran­chise.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

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We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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