Credit: Celltrion

Ko­re­a's Cell­tri­on blue­prints $514M bi­o­log­ics plant in Chi­na, beef­ing up biosim­i­lar, con­tract man­u­fac­tur­ing

The Chi­nese city of Wuhan might have sprung to world­wide in­famy for the coro­n­avirus out­break orig­i­nat­ing from one of its seafood mar­kets, but if Cell­tri­on has its way, it will be­come known as a cen­ter of bi­o­log­ics man­u­fac­tur­ing.

The Ko­re­an biosim­i­lars mak­er has bud­get­ed $514 mil­lion (₩600 bil­lion) over five years for a new plant in Wuhan, which it says will be Chi­na’s biggest bi­o­log­ics fa­cil­i­ty at a ca­pac­i­ty of 120,000 liters. A ground­break­ing cer­e­mo­ny is slat­ed for April.

Cell­tri­on is kick­ing off the new decade with am­bi­tious goals in­clud­ing faster copy­cat launch­es and even new drug de­vel­op­ment, chair­man Jung-jin Seo in­di­cat­ed at the JP Mor­gan health­care con­fer­ence last week.

“As we chart the com­pa­ny’s 2030 vi­sion, the com­pa­ny hopes to launch one biosim­i­lar prod­uct every year, reach­ing a to­tal num­ber of 18 prod­ucts by 2030,” Seo said in a state­ment. “Biosim­i­lars and val­ue added med­i­cines which we call ‘bioin­no­v­a­tives’(in­no­v­a­tive biosim­i­lars) are set to be our key growth dri­vers in 2020.”

The new fa­cil­i­ty in Wuhan — Cell­tri­on’s first site in Chi­na — is de­signed to de­vel­op and man­u­fac­ture their own bi­o­log­ics for the lo­cal mar­ket, as well as per­form­ing con­tract work for the emerg­ing wave of Chi­nese biotechs.

There’s a lo­gis­ti­cal ad­van­tage in ship­ping prod­ucts all around the coun­try from Wuhan, the cap­i­tal of the in­land province of Hubei, a Cell­tri­on rep told the Ko­rea Her­ald. The ex­ec al­so prais­es the city for its “fast-grow­ing bioin­dus­try clus­ter,” though it’s nowhere near Shang­hai’s hub sta­tus.

The mu­nic­i­pal gov­ern­ment signed a part­ner­ship agree­ment with the com­pa­ny on Tues­day.

Last sum­mer Cell­tri­on sig­naled its in­ter­est in en­ter­ing Chi­na through a joint ven­ture deal with Hong Kong’s Nan Fung Group. The part­ners set up a com­pa­ny dubbed Vcell around three FDA- and EMA- ap­proved biosim­i­lars — Rem­si­ma (Rem­i­cade knock­off), Trux­i­ma (Rit­ux­an knock­off) and Herzu­ma (Her­ceptin knock­off) — to try to get them through Chi­nese reg­u­la­tors to the mar­ket.

As part of that pact, Cell­tri­on al­so said it would be ex­plor­ing a fa­cil­i­ty in the coun­try.

Cell­tri­on will be en­ter­ing a crowd­ed mar­ket with well-heeled ri­vals — In­novent and Hen­lius on the biosim­i­lar side and WuXi on the CD­MO side, to list a few. But as Chi­na adds more bi­o­log­ics to the Na­tion­al Re­im­burse­ment Drug List and im­ple­ments a new sys­tem of procur­ing drugs for hos­pi­tals in a bid to con­tain health­care costs, there’s plen­ty of room for com­pe­ti­tion.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.