Endpoints News — Roche offers positive update on its anti-TIGIT effort; CVS move threatens a $9B franchise

Biotech Hub / By

10 December, 2021

. Hard to believe that we’re looking at the last full work week of the year coming up on Monday. What a year. There’s a special ASH report and panel review Monday. We’ll be wrapping the last daily report of 2021 on December 23 with a special look at top trends for 2022, as picked by the team. And then we’ll be working a part-time schedule to stay up with the news, but only online, through the holidays. . John Carroll Editor & Founder, Endpoints News

@JohnCendpts

1 Roche of­fers an up­beat two-plus-year look at its an­ti-TIG­IT com­bo ther­a­py — but will two deaths hurt its chances? by Nicole DeFeudis Roche’s Genen­tech got a leg up in the packed an­ti-TIG­IT race ear­li­er this year when the FDA grant­ed it the first break­through des­ig­na­tion in the field based on some up­beat mid-stage da­ta in non-small cell lung can­cer. Now, look­ing to keep its lead, the phar­ma gi­ant is of­fer­ing a two-and-a-half-year look at the same pa­tient group — but will two deaths crush its chances? A com­bi­na­tion of Genen­tech’s an­ti-TIG­IT can­cer tiragolum­ab plus PD-L1 in­hibitor Tecen­triq re­duced pa­tients’ risk of dis­ease pro­gres­sion or death by 38% com­pared to those who re­ceived Tecen­triq alone at a me­di­an fol­low-up of 2.5 years, the com­pa­ny said on Fri­day. In a pre-spec­i­fied ex­plorato­ry analy­sis of par­tic­i­pants with high lev­els of PD-L1, the com­bo re­duced the risk of dis­ease wors­en­ing or death by 71% com­pared to the Tecen­triq group. The com­bo al­so showed a ‘clin­i­cal­ly mean­ing­ful’ im­prove­ment in over­all re­sponse, with a rate of 69% in the com­bo group and 24.1% in the Tecen­triq group for PD-L1-high pa­tients. On the sec­ond end­point, over­all sur­vival, pa­tients in the broad­er pop­u­la­tion sur­vived a me­di­an of 23.2 months on the com­bo, com­pared to 14.5 months on just Tecen­triq, ac­cord­ing to Genen­tech. Me­di­an OS hasn’t yet been reached in the PD-L1-high sub­group that re­ceived the com­bo. How­ev­er, the com­pa­ny al­so re­port­ed two treat­ment-re­lat­ed deaths in the com­bi­na­tion group. While no ex­pla­na­tion was sup­plied, Mizuho’s Mara Gold­stein thinks tiragolum­ab still stands a chance. ‘While Gr.5 events are not to be tak­en light­ly, in the con­text of the ef­fi­ca­cy ob­served, it may not be a weighty is­sue,’ she wrote in a note to in­vestors on Fri­day. Click here to continue reading

Stéphane Bancel, Moderna CEO (AP Images, Boston Herald) 2 UP­DAT­ED: Mod­er­na says its mR­NA flu vac­cine cleared ear­ly stud­ies, but com­par­isons with oth­er vac­cines dri­ve stock down by Jason Mast Mod­er­na says that it’s on its way to hav­ing an mR­NA vac­cine against not one, but two dif­fer­ent sea­son­al virus­es. The biotech re­leased the first ear­ly da­ta from its flu pro­gram Fri­day morn­ing, an­nounc­ing that all dos­es of the shot sig­nif­i­cant­ly boost­ed an­ti­bod­ies in younger and old­er adults with­out “sig­nif­i­cant safe­ty find­ings.” A 500-per­son Phase II will con­firm dose lev­els and com­pare it to an ap­proved flu vac­cine, the com­pa­ny said, and prepa­ra­tions for a large piv­otal tri­al are un­der­way. Mod­er­na said it is al­so ad­vanc­ing new de­signs that can have po­ten­tial­ly broad­er cov­er­age of dif­fer­ent flu strains than cur­rent shots. The re­sults are the open­ing sal­vo in a four-head­ed (so far) race to de­vel­op the first mR­NA flu vac­cine, as Mod­er­na tries to edge out BioN­Tech, Sanofi sub­sidiary Trans­late Bio, and Cure­Vac past the gate. Al­though all four have pro­grams un­der­way, Mod­er­na is the first to an­nounce da­ta. Those da­ta, though, don’t give a clear an­swer on whether mR­NA can im­prove on pre­vi­ous tech­nolo­gies. Mod­er­na said the 50 mi­cro­gram dose of the shot, de­signed like most flu vac­cines to in­oc­u­late against four dif­fer­ent strains of the virus, in­creased an­ti­bod­ies against the two In­fluen­za A strains by eight-fold and ten-fold, re­spec­tive­ly, and against the two in­fluen­za strains by three-fold and two-fold. There was lit­tle dif­fer­ence in an­ti­bod­ies be­tween dose lev­els, the com­pa­ny said. Safe­ty da­ta echoed those from the Covid-19 vac­cine, with fa­tigue, myal­gia (mus­cle ache), and headache the most com­mon side ef­fects. Click here to continue reading

Xiayang Qiu, Regor Therapeutics CEO 3 Af­ter in­vest­ing in their Se­ries B, Lil­ly bags a li­cense for a batch of meta­bol­ic can­di­dates by Josh Sullivan Eli Lil­ly will li­cense in Re­gor Ther­a­peu­tics ther­a­pies for meta­bol­ic dis­or­ders, as a part of an agree­ment an­nounced Fri­day that will give the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion, part of which is an eq­ui­ty in­vest­ment. In a vague­ly word­ed re­lease, Lil­ly said it has a li­cense for cer­tain Re­gor “in­tel­lec­tu­al prop­er­ty” and will have an op­tion to ex­tend that li­cense. In ex­change, Lil­ly will over­see glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion for any ther­a­pies, with the ex­cep­tion of Chi­na, Macau, Hong Kong and Tai­wan. Re­gor, a Shang­hai-based com­pa­ny, will re­serve the rights to these re­gions. The com­pa­ny is el­i­gi­ble for up to $1.5 bil­lion in po­ten­tial pay­ments based on pre­clin­i­cal, clin­i­cal and com­mer­cial mile­stones, as well as tiered roy­al­ties from sales. Re­gor CEO Xi­ayang Qiu said that the col­lab­o­ra­tion is, in part, a recog­ni­tion of Re­gor’s core tech­nol­o­gy, the Com­put­er Ac­cel­er­at­ed Ra­tio­nal Dis­cov­ery plat­form. CARD, an­oth­er in a long line of fan­ci­ly named biotech com­pu­ta­tion­al plat­forms, is de­signed to cre­ate a more ef­fi­cient process for the dis­cov­ery of new drugs. Through CARD, the team has ad­vanced a num­ber of prod­ucts in its pipeline in just two years, in­clud­ing RGT-587 for on­col­o­gy, which is set to en­ter Phase I tri­als, and and RGT-075 to tar­get a glucagon-like pep­tide 1 re­cep­tor hor­mone, which stim­u­lates glu­cose-in­duced in­sulin se­cre­tion. That can­di­date is en­ter­ing Phase II/III tri­als. The com­pa­ny was found­ed in 2018 by a team that in­cludes two Pfiz­er vet­er­ans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Am­gen’s Chi­nese R&D op­er­a­tions. Re­gor’s fo­cus so far has been on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases. Click here to continue reading

4 CVS takes a swing at Bris­tol My­ers and Pfiz­er, ex­clud­ing cov­er­age of their megablock­buster Eliquis in 2022 by Zachary Brennan Bris­tol My­ers Squibb brought in more than $9 bil­lion in sales from its an­ti­co­ag­u­lant Eliquis in 2020, and it con­tin­ues to see growth with more than $8 bil­lion in sales in the first nine months of 2021 (and an­oth­er near­ly $4.5 bil­lion for Pfiz­er in 2021). But in 2022, one of the largest PBMs in the US, CVS Care­mark, has re­cent­ly de­cid­ed to no longer cov­er the megablock­buster, and in­stead will on­ly of­fer cov­er­age for war­farin and Janssen’s Xarel­to. That de­ci­sion will like­ly put a dent in Eliquis sales next year for both BMS and Pfiz­er. But BMS said the de­ci­sion should be lim­it­ed, telling End­points News in an emailed state­ment that while the Bris­tol My­ers Squibb-Pfiz­er al­liance “is dis­ap­point­ed” by this move to hin­der pa­tient ac­cess to Eliquis, the drug will con­tin­ue to have “pre­ferred sta­tus for 85% of CVS Health lives in 2022 and on­ly those pa­tients who have com­mer­cial health in­sur­ance plans with phar­ma­cy ben­e­fits man­aged by Zinc, specif­i­cal­ly, are sub­ject to their for­mu­la­ries and this de­ci­sion, ef­fec­tive Jan­u­ary 1, 2022. Im­por­tant­ly, 95% of Eliquis pa­tients na­tion­al­ly will not be ef­fect­ed by this for­mu­la­ry de­ci­sion by CVS/Zinc.” (Bold and ital­ics are theirs.) For some doc­tors, the de­ci­sion forces them to scram­ble and switch pa­tients to a new an­ti­co­ag­u­lant, and they don’t have time to fig­ure out if their pa­tients fall in­to the gap dis­cussed by BMS and Pfiz­er. Click here to continue reading

House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images) 5 Over­sight Com­mit­tee un­leash­es scathing drug pric­ing re­port as Sen­ate preps to vote on al­low­ing Medicare ne­go­ti­a­tions by Zachary Brennan Back in Jan­u­ary 2019, the late House Over­sight Com­mit­tee chair Eli­jah Cum­mings kicked off a near­ly 3-year-long drug pric­ing in­ves­ti­ga­tion that cul­mi­nat­ed to­day in a ma­jor new re­port de­tail­ing how prices for vi­tal drugs have risen sub­stan­tial­ly since their launch, while call­ing on the Sen­ate to pass a bill that will al­low Medicare to ne­go­ti­ate some prices. The com­mit­tee’s in­ves­ti­ga­tion fo­cused on 12 of the most ex­pen­sive drugs for Medicare, show­ing mas­sive price spikes that have ac­cu­mu­lat­ed over the years and made some drugs, like in­sulin, en­tire­ly un­af­ford­able for some, to the point where some di­a­bet­ics have had to ra­tion their life-sav­ing in­sulin, and some have died. Doc­u­ments ob­tained by the com­mit­tee show that sev­er­al of the com­pa­nies tar­get­ed Medicare specif­i­cal­ly to boost rev­enues. An in­ter­nal No­vo Nordisk slide deck from Oc­to­ber 2013 em­pha­sized, ‘Part D is the most prof­itable mar­ket for the No­vo Nordisk in­sulin port­fo­lio,’ and not­ed that in­sulin vol­ume for the Part D mar­ket was grow­ing three times faster than the com­mer­cial mar­ket. A 2016 pre­sen­ta­tion pre­pared for No­var­tis by an out­side con­sul­tant em­pha­sized, ‘Medicare is crit­i­cal to brand suc­cess, CMS spent ~$1 bil­lion on Gleevec in 2014.’ Build­ing off the work of three hear­ings with phar­ma­ceu­ti­cal ex­ec­u­tives from sev­en com­pa­nies, as well as oth­er pre­vi­ous re­ports, this fi­nal re­port in­cludes new find­ings from an in­ves­ti­ga­tion in­to Pfiz­er’s mar­ket­ing of its block­buster pain drug Lyri­ca, and a deep­er dive in­to the in­sulin prod­ucts from Eli Lil­ly, No­vo Nordisk, and Sanofi, which col­lec­tive­ly con­trol about 90% of the glob­al in­sulin mar­ket. Click here to continue reading

Vlad Coric, Biohaven chariman and CEO 6 As Bio­haven CEO Coric preps FDA fil­ing for new mi­graine spray, he’s al­ready scout­ing for celebri­ty spokesper­son by Beth Snyder Bulik Days af­ter re­port­ing pos­i­tive Phase III re­sults for in­tranasal mi­graine med za­veg­epant, Bio­haven chair­man and CEO Vlad Coric is talk­ing about mar­ket­ing plans. It’s a month or more be­fore Bio­haven will file for FDA ap­proval and like­ly a year be­fore launch, but Coric is al­ready think­ing about mes­sag­ing and com­mer­cial­iza­tion. His plan? A dual strat­e­gy to at­tract po­ten­tial pa­tients around speed to re­lief – za­veg­epant study re­sults show the spray can pro­vide re­lief in as fast as 15 min­utes and a re­turn to nor­mal in 30 min­utes – along with a sec­ondary an­ti-nau­sea ben­e­fit in us­ing an in­tranasal ver­sus a pill. ‘It’s go­ing to be com­ple­men­tary to Nurtec and many peo­ple are go­ing to want this around be­cause you don’t con­trol when a mi­graine hits,’ Coric said. ‘Now you can con­trol which of these tools you can take to­day to com­bat your mi­graine.’ He’s al­ready scout­ing for a new celebri­ty spokesper­son to add an­oth­er well-known voice to its group of ad­ver­tis­ing am­bas­sadors for Nurtec ODT that in­cludes re­al­i­ty TV star Khloe Kar­dashi­an and ac­tor and talk show host Whoopi Gold­berg. That’s all of course con­di­tion­al on FDA ap­proval. The pos­i­tive Phase III da­ta Bio­haven de­tailed ear­li­er this week showed za­veg­epant was su­pe­ri­or to place­bo on the co-pri­ma­ry end­points of pain free­dom and free­dom from most both­er­some symp­toms at two hours, and su­pe­ri­or to place­bo in de­liv­er­ing pain re­lief as ear­ly as 15 min­utes. Click here to continue reading

7 Bil­lion­aire BioN­Tech back­ers have been kick­ing the tires at No­var­tis’ big gener­ics arm — re­port While the ul­ti­mate fate of No­var­tis’ big gener­ics arm San­doz may still be up in the air, there’s no doubt it’s in play as a po­ten­tial buy­out tar­get. Overnight, Reuters picked up on a re­port out of Ger­many that EQT and the bil­lion­aire Strüng­mann broth­ers — en­joy­ing a huge wind­fall from the overnight suc­cess of BioN­Tech’s mR­NA Covid vac­cine — are kick­ing the tires at San­doz. And No­var­tis CEO Vas Narasimhan con­firmed it. “There have been var­i­ous re­quests for more in­for­ma­tion,’ Narasimhan told WirtschaftsWoche. ‘But no con­crete of­fers.’ This is the sec­ond re­port out of Ger­many on the dis­cus­sions over San­doz. Han­dels­blatt re­port­ed more than a week ago that EQT and the Strüng­manns — Thomas and An­dreas — were in talks over a $21 bil­lion bid. And it would­n’t be their first gener­ics deal, as the bil­lion­aires sold Hexal to No­var­tis in 2005. Narasimhan’s de­ci­sion to con­firm their in­ter­est — rather than just re­main mum — leaves lit­tle doubt in just how much he would like an auc­tion to get go­ing. He just lined up a $21 bil­lion fund for new deals with his sale of the Roche stake. A San­doz sale would make him a for­mi­da­ble po­ten­tial buy­er in 2022. Narasimhan got every­one’s at­ten­tion at the end of Oc­to­ber when he flagged a plan to un­der­take a strate­gic re­view of San­doz to see whether the gener­ics group should stay in­side No­var­tis, or be sold or spun off in­to an in­de­pen­dent com­pa­ny. Click here to continue reading

8 The lat­est health­care SPAC comes in at $200M with a laser fo­cus on ar­ti­fi­cial in­tel
https://reports.endpts.com/79153abc/7e206a7a/eae44ffb/index.html

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