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.”

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Sanofi, Re­gen­eron etch out an­oth­er PhI­II vic­to­ry for Dupix­ent, eas­ing se­vere itch and clear­ing le­sions

Sanofi and Regeneron can boast of another inflammatory disease where Dupixent has proven effective.

The best-selling drug, which targets both IL-4 and IL-13, has delivered a clean sweep in a Phase III trial for prurigo nodularis, a chronic disease characterized by itch so intense that it can affect patients’ sleep and psychology. Thick skin lesions can cover most of the body.

On the primary endpoint, 37% of patients taking Dupixent saw a clinically meaningful reduction in itch compared to 22% of those on placebo (p=0.0216) at week 12. All secondary endpoints were also met, including clearance of skin lesions and improvement in quality of life.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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Oc­u­lar Ther­a­peu­tix ham­mered by a PhII fail­ure in dry eye dis­ease — shares tank

Ocular Therapeutix $OCUL has had its ups and downs in the 7 years since it went public. Friday was one of those down days.

The Bedford, MA-based biotech reported that its lead experimental eye drug, OTX-CSI (cyclosporine intracanalicular insert), failed a Phase II trial for dry eye disease. And the stock experienced one of its periodic meltdowns, dropping more than 30% ahead of the bell.

The therapy flat failed the primary endpoint: increased tear production at 12 weeks as measured by the Schirmer’s Test compared to the vehicle control group. And while investigators called out an improvement from baseline in “signs of dry eye disease as measured by total corneal fluorescein staining (CFS) and symptoms of dry eye disease as measured by the visual analogue scale (VAS) eye dryness in subjects treated with the OTX-CSI insert,” it wasn’t statistically significant.