What's he think­ing about? Vivek Ra­maswamy lines up a heavy­weight ti­tle fight for a late-stage di­a­betes drug

Vivek Ra­maswamy

Vivek Ra­maswamy has carved out a late-stage al­liance with a small biotech to take him in­to one of the most dif­fi­cult big mar­kets in the bio­phar­ma hand­book.

Ra­maswamy’s Roivant — the par­ent com­pa­ny to a line­up of “vant” star­tups — has agreed to pay Pox­el $50 mil­lion in cash and up to $600 mil­lion in mile­stones to take their di­a­betes drug in­to Phase III in the world’s biggest mar­kets. The up­front in­cludes $15 mil­lion for an eq­ui­ty stake.

A spokesper­son for Roivant con­firmed to me that Ra­maswamy will now set up a new biotech which will now build a pipeline in the field. This will be his 7th, and Ra­maswamy ev­i­dent­ly has the name picked out. We spied this list­ing in Bermu­da: Meta­vant.

The part­ner­ship brings to­geth­er two dif­fer­ent play­ers with their own off­beat strate­gies in drug de­vel­op­ment.

Thomas Kuhn, Pox­el

Mer­ck KGaA spin­out Pox­el (EPA: $POX­EL) has gar­nered sub­stan­tial at­ten­tion for its suc­cess­ful Phase IIb tri­al in Japan of imeglim­in, track­ing he­mo­glo­bin A1c re­duc­tions of 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-dai­ly. The da­ta brought in Sum­it­o­mo Dainip­pon Phar­ma to part­ner on Asia in a $300 mil­lion deal, with $42 mil­lion up front. And that came some months af­ter Pox­el CEO Thomas Kuhn had vowed to do it alone in Japan, telling me that they could get an ap­proval on a scaled down Phase III with 1,000 pa­tients.

Kuhn had es­ti­mat­ed a US tri­al would re­quire 7,000 pa­tients, which is why small biotechs don’t do late-stage di­a­betes drug de­vel­op­ment in the big mar­kets.

Now Ra­maswamy will be tack­ling a po­ten­tial­ly enor­mous­ly ex­pen­sive de­vel­op­ment pro­gram with a high reg­u­la­to­ry bar on safe­ty, with Pox­el on the hook for $25 mil­lion of the costs. And the biotech en­tre­pre­neur, re­cent­ly slammed by the com­plete fail­ure of its orig­i­nal ef­fort on Alzheimer’s, hint­ed that it plans to make more deals around meta­bol­ic drugs.

While Roivant has been hit hard by clin­i­cal fail­ure, Ra­maswamy re­mains one of the most ef­fec­tive fi­nan­cial en­gi­neers in the busi­ness. He’s raised $2.5 bil­lion in a lit­tle more than three years, in­clud­ing $1.1 bil­lion from Soft­Bank. So far, his in-li­cens­ing deals have been con­cen­trat­ed heav­i­ly around Big Phar­ma’s pipeline dis­cards, or in fields where the big play­ers were look­ing for a part­ner to help shoul­der ricks and ex­pense.

He’ll now be tack­ling a field dom­i­nat­ed by a few big play­ers like No­vo Nordisk, Sanofi and Eli Lil­ly, which have the kind of deep pock­ets need­ed to push through late-stage de­vel­op­ment.

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?

Sev­er­al weeks af­ter get­ting hit with an RTF, Y-mAbs lands ap­proval for its oth­er neu­rob­las­toma can­di­date

Nearly two months after handing Y-mAbs a refusal to file letter for one of its main neuroblastoma candidates, the FDA gave the biotech an accelerated OK for the other — but with a box warning.

Y-mAbs, which flew mostly under the radar until a few years ago, snagged approval for naxitamab-gqgk as a second-line treatment in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Patients older than 1 year old can take the drug for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. The good news cushioned last month’s blow, sending the company’s stock $YMAB — which sank more than 18% upon news of the RTF — up 10.15% as of Monday morning.

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.

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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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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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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