Roivant un­der­goes ma­jor re­struc­tur­ing, cut­ting and shift­ing its staff

Vivek Ra­maswamy’s Roivant is un­der­go­ing a self-im­posed shake­up, lay­ing off a chunk of its staff and shift­ing oth­ers to its sub­sidiaries. The com­pa­ny has launched two new busi­ness units and a new start­up as part of the over­haul: two units that will man­age new start­up cre­ations un­der the Roivant fam­i­ly, and one drug com­pa­ny with a pul­monary ar­te­r­i­al hy­per­ten­sion med in hand.

Vivek Ra­maswamy

The news comes months af­ter Roivant’s sub­sidiary Ax­o­vant im­plod­ed in the face of a late-stage Alzheimer’s flop. As part of the re­or­ga­ni­za­tion, Roivant has laid off 10% of its staff, the com­pa­ny said in a state­ment. That in­cludes main­ly HR, IT, and ac­count­ing pro­fes­sion­als do­ing “cen­tral sup­port” func­tions, Roivant said. When asked for de­tails, Roivant said 67 em­ploy­ees were let go (out of rough­ly 700 em­ployed across the Roivant fam­i­ly of com­pa­nies), and 125 were as­signed to its sub­sidiaries. Un­named sources fa­mil­iar with the mat­ter told Fierce­Biotech the shake­up was a “blood­bath.”

“We con­tin­ue to hire in sci­en­tif­ic and busi­ness func­tions at Roivant and across the Vant fam­i­ly; how­ev­er, key op­er­a­tional func­tions will be hired pri­mar­i­ly at the Vants go­ing for­ward,” a com­pa­ny spokesman said in an email.

In a Tues­day an­nounce­ment, Roivant said its formed two new busi­ness units to churn out new star­tups and push ear­ly-stage sci­ence for­ward. First up, it cre­at­ed Roivant Phar­ma to fo­cus on “end-to-end bio­phar­ma­ceu­ti­cal com­pa­ny cre­ation in new ther­a­peu­tic ar­eas.” Mayukh Sukhatme, for­mer­ly Roivant’s chief busi­ness of­fi­cer, will head that group up as pres­i­dent.

Sec­ond, Roivant launched Roivant Health, a new busi­ness unit fo­cused on launch­ing com­pa­nies that push med­i­cines to “emerg­ing mar­kets and im­prove the process of de­vel­op­ing and com­mer­cial­iz­ing new med­i­cines through the ap­pli­ca­tion of tech­nol­o­gy.” For that arm, Ben­jamin Zim­mer, who over­saw the launch of Data­vant while head of spe­cial projects at Roivant, will serve as pres­i­dent.

Mayukh Sukhatme

“I am ex­cit­ed to el­e­vate sev­er­al of Roivant’s tal­ent­ed lead­ers to new roles that will en­able them to tack­le new chal­lenges,” Ra­maswamy said in a state­ment. “Our goal is to de­liv­er trans­for­ma­tive in­no­va­tion in health­care. Go­ing for­ward, we will ex­pand the scope of our fo­cus to in­clude the ad­vance­ment of po­ten­tial­ly trans­for­ma­tive as­sets in­to clin­i­cal de­vel­op­ment, even if they are at ear­li­er stages of de­vel­op­ment than much of our pipeline to date.”

At the same time as all this re­or­ga­ni­za­tion, Roivant al­so not­ed that its launched a com­pa­ny called Al­ta­vant Sci­ences. The com­pa­ny will be de­vel­op­ing a drug called RVT-1201, a po­ten­tial treat­ment for pul­monary ar­te­r­i­al hy­per­ten­sion (PAH) and oth­er in­di­ca­tions. Al­ta­vant will be led by CEO William Symonds, who’s been in se­nior lead­er­ship at Roivant since its 2014 in­cep­tion, most re­cent­ly as chief de­vel­op­ment of­fi­cer. You might know Symonds from his work over­see­ing the de­vel­op­ment of So­val­di and Har­voni for hep C while at Phar­mas­set and Gilead.

“The stan­dard of care for PAH re­mains in­suf­fi­cient,” Symonds said in a state­ment. “I look for­ward to di­rect­ing the newest mem­ber of the Roivant fam­i­ly as we de­vel­op RVT-1201 in a thought­ful, rig­or­ous, and ef­fi­cient man­ner that draws on best prac­tices de­vel­oped at Roivant in ar­eas in­clud­ing pa­tient en­gage­ment, the use of tech­nol­o­gy in tri­als, and the analy­sis of clin­i­cal tri­al re­sults.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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