Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Look­ing to ce­ment its lead in packed MS mar­ket, Roche's Ocre­vus un­corks new da­ta in ear­ly-stage pa­tients

Among a pos­i­tive­ly jam-packed mul­ti­ple scle­ro­sis mar­ket, Roche’s Ocre­vus has man­aged to stand out for what the Swiss drug­mak­er is call­ing the most suc­cess­ful launch in its long his­to­ry. But in or­der to press its ad­van­tage, Ocre­vus is look­ing to ear­li­er-stage pa­tients, and new in­ter­im da­ta should help build its case there.

Af­ter 48 weeks on Roche’s Ocre­vus, 85% of new­ly di­ag­nosed pri­ma­ry pro­gress­ing or re­laps­ing MS pa­tients with­out a his­to­ry of dis­ease mod­i­fy­ing ther­a­py post­ed no dis­ease ac­tiv­i­ty, in­clud­ing dis­ease pro­gres­sion or re­lapse, ac­cord­ing to in­ter­im da­ta set to be pre­sent­ed this week­end at the vir­tu­al Amer­i­can Acad­e­my of Neu­rol­o­gy meet­ing.

In the open-la­bel Phase II­Ib EN­SEM­BLE study, Ocre­vus, a CD20 tar­get­ing mon­o­clon­al an­ti­body, cut pa­tients’ av­er­age an­nu­al­ized re­lapse rate to 0.005 and showed con­sis­tent ben­e­fit in tar­get­ed bio­mark­ers. Ocre­vus cut neu­ro­fil­a­ment light chain — a bio­mark­er for neu­ron func­tion — to “near­ly healthy lev­els” af­ter near­ly a year of treat­ment.

The newest da­ta were part of a three-part roll­out at AAN for Roche, which al­so re­leased post hoc da­ta for Ocre­vus in re­duc­ing tu­mor le­sions in pri­ma­ry pro­gress­ing MS and a two-year study on li­a­bil­i­ty claims.

Ocre­vus is one of the best sell­ing MS drugs in the world, rak­ing in $4.68 bil­lion in sales in 2020 at a 24% year-over-year growth clip. But plen­ty of com­peti­tors are aim­ing for the throne, in­clud­ing a small biotech chas­ing the same CD20 B cell tar­get as Roche’s drug.

Back in De­cem­ber, TG Ther­a­peu­tics rolled out da­ta show­ing its ubli­tux­imab led to re­duc­tions of around 60% and 50% in an­nu­al­ized re­lapse rate com­pared to Sanofi’s Auba­gio in a pair of Phase III tri­als (p<0.005). In each of the stud­ies, the ARR is less than 0.10. TG said the da­ta were good enough to spur an FDA sub­mis­sion at some point in the mid­dle of 2021.

Auba­gio, or ter­i­fluno­mide, is an 8-year-old drug that’s of­ten used as a bench­mark in these tri­als. No­var­tis got the green light for its block­buster-to-be Kes­imp­ta af­ter demon­strat­ing a sig­nif­i­cant re­duc­tion in ARR of 51% and 59% over the ac­tive con­trol arm in a pair of tri­als. J&J’s pones­i­mod, mean­while, met the pri­ma­ry end­point by hit­ting an ARR of just 20% com­pared to 29% for Auba­gio, trans­lat­ing to a re­duc­tion of 30.5%.

If ap­proved, ubli­tux­imab would come with the added ben­e­fit of a twice-year­ly, one-hour in­fu­sion sched­ule. That’s a big con­ve­nience step up from Ocre­vus, which is al­so ad­min­is­tered twice a year but re­quires 2.5 hours to in­fuse.

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.

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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.

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.

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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.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

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.

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Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.

Neil Desai, Aadi Bioscience CEO (Specialised Therapeutics via YouTube)

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

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SPACs have become the preferred fast track for public markets over the past year, but apparently there’s still room for a good, old-fashioned reverse merger.

Cancer-focused Aadi Bioscience announced Monday that they would merge with the struggling public biotech Aerpio Pharmaceuticals. To go along with the merger, Aadi raised $155 million from private investors to commercialize their lead drug, Fyarro, which is now sitting before the FDA. Acuta Capital Partners and KVP Capital led the round.

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