Debra Yu (LianBio)

Pfiz­er hands Lian­Bio $70M to tag along Per­cep­tive's Chi­na play, with an eye to beef­ing up re­gion­al port­fo­lio

When Per­cep­tive un­veiled its care­ful­ly cu­rat­ed syn­di­cate for Lian­Bio’s $310 mil­lion Se­ries A, Pfiz­er stood out as the on­ly phar­ma amid a mar­quee group of VCs. It turns out that the drug­mak­er wasn’t on­ly look­ing to share the fruits of Lian­Bio’s la­bor, it al­so wants to get down in­to the trench­es.

Pfiz­er has put an ad­di­tion­al $70 mil­lion on the ta­ble for Lian­Bio — which Per­cep­tive set out to shape in­to a “best-in-class sourc­ing and de­vel­op­ment en­gine” in Chi­na — to in-li­cense pro­grams that they can then co-de­vel­op. If a drug reach­es the mar­ket, Pfiz­er will be first in line to ne­go­ti­ate for stand­alone com­mer­cial deals.

Kon­stan­tin Poukalov

Hav­ing just re­cent­ly signed off on a $480 mil­lion col­lab­o­ra­tion to de­vel­op and com­mer­cial­ize CStone’s PD-1 in Chi­na, Doug Gior­dano, SVP of Pfiz­er world­wide busi­ness de­vel­op­ment, said the new deal ex­pands its “abil­i­ty to part­ner across the biotech ecosys­tem” and de­liv­er med­ical break­throughs to Chi­nese pa­tients.

“We’ve heard this re­peat­ed­ly from Big Phar­mas over the years that they get pro­grams com­ing down from glob­al but there’s of­ten not as much em­pha­sis and lit­tle ac­tiv­i­ty at the re­gion­al lev­el for busi­ness de­vel­op­ment,” De­bra Yu, Lian­Bio’s pres­i­dent/CBO and a Pfiz­er alum, told End­points News.

For Lian­Bio, the al­liance doesn’t just of­fer heavy­weight en­dorse­ment of its mod­el but al­so a way to tap in­to com­mer­cial in­fra­struc­ture that Pfiz­er has built over a decade.

Kon­stan­tin Poukalov, man­ag­ing di­rec­tor at Per­cep­tive and ex­ec­u­tive chair­man at Lian­Bio, not­ed that the in-kind help that Pfiz­er has com­mit­ted might just be as im­por­tant as the cash. From clin­i­cal tri­al ex­per­tise — Pfiz­er has 60-plus stud­ies un­der­way in the coun­try — and KOL net­work to cre­at­ing mar­ket ac­cess and deal­ing with the re­im­burse­ment process, the phar­ma gi­ant brings sig­nif­i­cant knowl­edge and ca­pac­i­ty to the pact.

Bing Li

In par­tic­u­lar, he adds, Lian­Bio will be pre­sent­ing to Pfiz­er as­sets that re­quire a large, spread-out sales force to cov­er vast ge­o­graph­i­cal re­gions. As­sets that are more tar­get­ed around spe­cif­ic cen­ters of care are more like­ly to be han­dled by the 30-plus Lian­Bio staffers (they’re still re­cruit­ing) CEO Bing Li is lead­ing in Shang­hai and Bei­jing.

As Yu scouts new deals with her New Jer­sey-based team, she be­lieves hav­ing Pfiz­er on board would con­vince biotech part­ners that by li­cens­ing Chi­na rights to Lian­Bio they will get the “best of both worlds.”

“It’s a very spe­cial kind of be­spoke cre­ative part­ner­ship that ben­e­fits all the three par­ties that are in­volved,” she said.

Pre­vi­ous­ly, Lian’s pitch­es main­ly re­volved around de­tailed mar­ket analy­ses and tai­lor-made de­vel­op­ment pro­pos­als that Bridge­Bio CEO Neil Ku­mar has praised as cre­ative. For $26.5 mil­lion in near-term pay­ments, he hand­ed over two tar­get­ed can­cer drug can­di­dates and gave away pref­er­en­tial fu­ture ac­cess to pro­grams across his sub­sidiaries’ port­fo­lio.

MyoKar­dia, mean­while, pro­vid­ed Lian with its first car­dio drug be­fore Bris­tol My­ers Squibb bought it for $13 bil­lion. Lian paid $40 mil­lion up­front for mava­camten and is on the hook for an­oth­er $147.5 mil­lion.

While Lian doesn’t en­vi­sion do­ing an­oth­er deal like the Pfiz­er one — elect­ing in­stead to pri­or­i­tize find­ing new drugs for its pipeline — Poukalov be­lieves oth­er phar­ma gi­ants are sim­i­lar­ly look­ing for ways to get their hands on drugs they may not oth­er­wise have ac­cess to.

“Just like you’ve seen in As­traZeneca’s case where they were able to do re­gion­al spe­cif­ic deals to dri­ve re­gion­al rev­enue, I think that’s top of mind for a lot of oth­er MNCs that are try­ing to evolve and re­al­ly kind of con­tin­ue to an­chor their po­si­tion in the mar­ket­place,” Poukalov said.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Pascal Soriot (Getty)

As­traZeneca CEO So­ri­ot plans new study to test that con­tro­ver­sial 90% ef­fi­ca­cy fig­ure, wait­ing for US da­ta be­fore go­ing to FDA

Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.