With mo­men­tum from FDA OK, SK Bio­phar­ma to breath new life in­to Ko­re­an biotech with $850M IPO — re­port

SK Life Sci­ence’s re­cent suc­cess at the FDA is set­ting its par­ent com­pa­ny nice­ly for a $850 mil­lion IPO in Ko­rea, the Fi­nan­cial Times re­port­ed.

The group — a sub­sidiary of the con­glom­er­ate SK Hold­ings ded­i­cat­ed to drug dis­cov­ery and de­vel­op­ment — filed its pre­lim­i­nary ap­pli­ca­tion to the Ko­rea Ex­change late last month. But the re­cent US ap­proval for epilep­sy drug Xco­pri, or cenoba­mate, raised an­a­lysts’ ex­pec­ta­tions on the amount they can bag.

“Giv­en the cur­rent mar­ket cir­cum­stances, they will be able to raise more than Won1tn,” an in­vest­ment banker close to the deal told the FT. That trans­lates to over $849 mil­lion.

Lo­cal an­a­lysts quot­ed by the pa­per are peg­ging Xco­pri’s val­ue at more than $4.67 bil­lion (Won5.5tn) — which would buoy the com­pa­ny’s mar­ket val­ue close to $6.8 bil­lion (Won8tn).

A strong new en­trant would bring some need­ed en­er­gy to South Ko­rea’s biotech sec­tor, whose rep­u­ta­tion has suf­fered in scan­dal af­ter scan­dal in­volv­ing some of its bell­wether com­pa­nies. Gov­ern­ment of­fi­cials have launched probes against sev­er­al al­leged se­ri­ous mis­con­ducts: Han­mi hid­ing pa­tient deaths and tri­al fail­ures from the pub­lic, Sam­sung Bi­o­Log­ics in­flat­ing its val­ue to get list­ed on the stock ex­change, Sil­la­Jen ex­ec­u­tives en­gag­ing in in­sid­er trad­ing ahead of a dis­ap­point­ing clin­i­cal an­nounce­ment. Oth­er bad news, such as the im­plo­sion of He­lixmith’s plas­mid prod­uct, have fur­ther shak­en in­vestors’ con­fi­dence.

Seb­by Bor­riel­lo

SK Bio­phar­ma can look to bur­nish its prospects with a planned launch of Xco­pri in the sec­ond quar­ter of 2020 — pend­ing DEA sched­ul­ing — as well as the mus­cle and com­mit­ment pro­vid­ed by the gi­ant cor­po­ra­tion it’s teth­ered to.

Chief com­mer­cial of­fi­cer Seb­by Bor­riel­lo pre­vi­ous­ly told End­points News that they plan to even­tu­al­ly mar­ket the drug in Ko­rea, Japan and Chi­na as well, while part­ner (and Ax­o­vant spin­out) Arvelle Ther­a­peu­tics han­dles Eu­rope.

“The mar­ket is like­ly to re­cov­er next year on the back of SK’s de­but, al­though in­vestor sen­ti­ment and ex­pec­ta­tions for new block­buster drugs have been damped by failed clin­i­cal tri­als this year,” wrote Sun Min-jung, an an­a­lyst at Hana Fi­nan­cial Group, in a re­port­ed quot­ed by the FT.

The com­pa­ny has se­lect­ed Cit­i­group and NH In­vest­ment & Se­cu­ri­ties as lead man­agers for the IPO deal, which is ex­pect­ed to close in Jan­u­ary.

So­cial im­age: Shut­ter­stock

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.