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.

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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