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.

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: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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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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Donald Trump, AP

Trump reach­es for his pen as long-await­ed ex­ec­u­tive or­der on drug man­u­fac­tur­ing on-shoring fi­nal­ly ar­rives — re­ports

President Trump will sign a long-rumored executive order later today that is designed to spur more made-in-the-USA therapies, according to a slate of new reports out Thursday morning.

Drug manufacturing circles have been buzzing about this EO for months now, wondering how Trump plans to require the on-shoring of certain therapies.

According to the Bloomberg report, White House trade adviser Peter Navarro told reporters that the administration will come up with a list of essential medicines Trump wants to have made inside the US. The order will direct government purchasers to buy these essential meds from US suppliers. The reports add that the order relaxes drug safety and environmental regulations to make it happen.

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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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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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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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.