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.”

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

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

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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