More ques­tions than an­swers for bio­phar­ma af­ter UK elec­tion; In­ter­cept gets FDA ad­vi­so­ry date, and a PDU­FA de­lay

→ On Thurs­day, vot­ers in the UK hand­ed Boris John­son’s Con­ser­v­a­tive gov­ern­ment, and its ag­gres­sive Brex­it stance, a clear ma­jor­i­ty. Urte Jaki­mavi­ciute, Glob­al­Da­ta‘s se­nior di­rec­tor of mar­ket re­search, weighed in on the biotech im­pli­ca­tions.

“The phar­ma sec­tor has been al­lo­cat­ing sig­nif­i­cant amounts of mon­ey to deal with any po­ten­tial con­se­quences of Brex­it, and with Con­ser­v­a­tives win­ning the elec­tion, Boris John­son’s with­draw­al agree­ment should be backed by the UK’s par­lia­ment. Even though the UK is set to leave by Jan­u­ary 31, it is un­clear what kind of re­la­tion­ship with the EU Boris John­son will seek. No mat­ter what con­tin­gency plans are in place and how much funds phar­ma com­pa­nies are al­lo­cat­ing to deal with the con­se­quences of Brex­it, it is very hard to be ready for what­ev­er is go­ing to hap­pen due to an enor­mous de­gree of un­cer­tain­ty sur­round­ing the process. You can­not ful­ly pre­pare for some­thing that you can­not con­trol.”

In­ter­cept Phar­ma­ceu­ti­cals $ICPT, one of the lead­ing play­ers in the heat­ed race to get a NASH drug ap­proved, re­port­ed late-stage da­ta ear­li­er this year that showed its ex­per­i­men­tal drug met the main goal of im­prov­ing scores on liv­er fi­bro­sis, but not NASH res­o­lu­tion. Buoyed by its de­gree of suc­cess in a field lit­tered with fail­ure, the com­pa­ny sub­mit­ted an FDA mar­ket­ing ap­pli­ca­tion. On Fri­day, it said the FDA had set its ad­vi­so­ry com­mit­tee da­ta to de­lib­er­ate on the ap­prov­abil­i­ty of the drug for April 22, 2020 — which will like­ly de­lay the agency’s fi­nal de­ci­sion on the drug by three months. “This is un­for­tu­nate­ly af­ter the cur­rent PDU­FA of March 26, 2020 and thus we (and ICPT) ex­pect the PDU­FA will like­ly get pushed from March to June 2020 now,” Jef­feries an­a­lyst Michael Yee wrote in a note. “We had pre­vi­ous­ly flagged this po­ten­tial change in notes and our video but don’t think it’s a big deal, is sim­i­lar to the AM­RN sit­u­a­tion, and re­flects the dif­fi­cul­ties of get­ting Ad­com’s or­ga­nized.” Sep­a­rate­ly, In­ter­cept said it has al­so sub­mit­ted an ap­pli­ca­tion to mar­ket the drug in Eu­rope.

→On­coSec $ONCS an­nounced in­ter­im re­sults from a phase II tri­al test­ing their in­ter­leukin 12 ther­a­py TA­VO in com­bi­na­tion with Mer­ck‘s Keytru­da. The over­all re­sponse rate was 28.5%, with 4 out of 14 eval­u­at­ed pa­tients ex­pe­ri­enc­ing par­tial re­spons­es that were char­ac­ter­ized as “rapid tu­mor re­duc­tions.” Da­ta is still be­ing col­lect­ed, they said, with all pa­tients hav­ing un­der­gone 6 to 9 months of treat­ment.

→Trans­gene $TNG an­nounced that a phase II tri­al test­ing TG4010 in non-small cell lung can­cer has failed — so it is aban­don­ing the ex­per­i­men­tal IL-2 drug. The French biotech did not re­lease spe­cif­ic re­sults. It’s their sec­ond clin­i­cal fail­ure, fol­low­ing the Phase III flop of the on­colyt­ic virus pro­gram they ran with part­ner Sil­la­Jen. The com­pa­ny al­so signed a $13 mil­lion part­ner­ship with As­traZeneca in May.

→Anixa Bio­sciences $ANIX is de­lay­ing its pre­clin­i­cal CAR–T treat­ment, cit­ing the need for ge­net­ic en­gi­neer­ing. The com­pa­ny, in its for­mer guise as Itus Cor­po­ra­tion, li­censed The Wis­tar In­sti­tute’s CAR-T tech for sol­id tu­mors, fo­cus­ing first on ovar­i­an can­cer. Now, cit­ing their lead sci­en­tist and in­ven­tor of their CAR-T tech, Jose Cone­jo-Gar­cia, Anixa said the tech could use en­hanced ge­net­ic en­gi­neer­ing that would im­prove the vi­ral vec­tor and pro­mote more fol­li­cle-stim­u­lat­ing hor­mone on the trans­formed T-Cells.  “This op­ti­miza­tion work may take an ad­di­tion­al year,” they wrote, “re­sult­ing in the fil­ing of the IND in late 2020, with clin­i­cal tri­als to com­mence in 2021.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.