Launch a new com­pa­ny, steer a $150M IPO and ink a big da­ta col­lab­o­ra­tion — they call it Mon­day at Vivek Ra­maswamy’s Roivant

Vivek Ra­maswamy’s first Phase III may have been a nasty fail­ure, but there’s no sign it’s slowed him down one tiny bit. We have three new moves to re­port this morn­ing in­volv­ing a new up­start in the ranks, a big IPO and a da­ta deal with a big CRO.

Let’s start with the new biotech.

Bill Ger­hart

A year af­ter the team at Patara Phar­ma tout­ed the re­sults of a Phase IIa study for their lead drug to treat chron­ic cough in IPF pa­tients, they’ve packed up shop and tak­en their pro­gram to join up with the fast-grow­ing crew at Vivek Ra­maswamy’s Roivant Sci­ences.

Patara signed off on their web­site and this morn­ing emerged as Respi­vant, Roivant’s 13th vant com­pa­ny — with oth­ers un­der con­struc­tion.

And that’s not all. 

The rest­less Ra­maswamy of­fered up deal terms for Urovant’s $150 mil­lion-or-so IPO while Data­vant struck a deal to col­lab­o­rate with the big CRO Parex­el on gath­er­ing mass amounts of new da­ta on drugs.

Ah­met Tu­tun­cu

In their deal to launch Respi­vant, Roivant is leav­ing Bill Ger­hart in charge of the com­pa­ny as they lead up to a Phase IIb tri­al for IPF-re­lat­ed cough. Frank Tor­ti, the new in­vest­ment chair at Roivant, is the chair­man. 

Ex­ec­u­tive vice pres­i­dent for clin­i­cal and reg­u­la­to­ry Ah­met Tu­tun­cu and ex­ec­u­tive vice pres­i­dent for de­vel­op­ment and man­u­fac­tur­ing Pravin Soni will al­so be part of Respi­vant, which is set­ting up a Phase IIb for RVT-1601, “a mast cell sta­bi­liz­er with pleotrop­ic im­mune mod­u­lat­ing prop­er­ties de­liv­ered di­rect­ly to the lungs via a hand­held aerosol de­vice.”

Pravin Soni

Last fall the com­pa­ny re­port­ed that in a 24-pa­tient Phase II tri­al the ther­a­py demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in day­time and 24-hour cough fre­quen­cy among id­io­path­ic pul­monary fi­bro­sis pa­tients com­pared to a place­bo fol­low­ing 14 days of treat­ment. 

That new tri­al should get start­ed in Q1 of next year.

Travis May

Travis May at Data­vant, mean­while, struck a deal with Parex­el to work to­geth­er on us­ing “re­al-world” da­ta in clin­i­cal stud­ies. For Parex­el, it’s a chance to demon­strate an abil­i­ty to in­cor­po­rate da­ta in de­sign­ing clin­i­cal tri­als for its con­sid­er­able ar­ray of de­vel­op­ment clients around the world. And for Data­vant, it’s a chance to get a high-pro­file play­er in the CRO world to val­i­date the work it’s do­ing. 

Over at Urovant, the biotech plans to sell 10 mil­lion shares at a range of $14 to $16 each, putting the fi­nancier’s tal­ents at fundrais­ing to the test af­ter his maid­en ef­fort at Ax­o­vant saw his first Phase III fail bad­ly.

Im­age: Vivek Ra­maswamy.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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