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.”

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.