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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

Leo Tarkovsky, Fingerpaint Group's new chief commercial officer

Fin­ger­paint Group taps for­mer WPP and Mc­Cann Health ex­ec for new com­mer­cial role

Healthcare agency veteran Leo Tarkovsky has joined Fingerpaint Group as chief commercial officer to oversee its growing portfolio of pharma and healthcare agencies and communications companies.

Tarkovsky came to Fingerpaint from WPP where he was EVP for global healthcare growth over the past year. Before that served at McCann Health for seven years including as president overseeing the New York agencies with pharma clients including AstraZeneca, Bristol Myers Squibb, Eli Lilly and Johnson & Johnson’s Janssen.

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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