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.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.