Still trail­ing far be­hind a block­buster ri­val, No­var­tis gath­ers an­oth­er round of pos­i­tive sur­vival da­ta for Kisqali

Just two months ago, No­var­tis’ team turned up at AS­CO with some clear­ly pos­i­tive im­proved sur­vival rates for a group of pre-menopausal breast can­cer pa­tients tak­ing the CDK 4/6 drug Kisqali. And now they’re back, say­ing they al­so scored in a sep­a­rate tri­al track­ing OS among an­oth­er group of post-menopausal women tak­ing the block­buster wannabe.

Su­sanne Schaf­fert No­var­tis

We won’t hear the de­tails on the Monaleesa-3 da­ta un­til they can be rolled out lat­er at a sci­en­tif­ic con­fer­ence, but in­ves­ti­ga­tors say the drug scored on the key end­point in first-line and sec­ond-line cas­es. And this ex­pands on their boast for hold­ing the first — though no longer the on­ly — pos­i­tive sur­vival re­sults in the field, some­thing No­var­tis on­col­o­gy chief Su­sanne Schaf­fert says she’s “thrilled” to see.

The key ques­tion, though, is what’s it go­ing to take to carve away mar­ket share from the dom­i­nant CDK 4/6 — Pfiz­er’s Ibrance — which hit the mar­ket sev­er­al years ago. De­spite flunk­ing their sur­vival end­point, Pfiz­er reaped a $1.26 bil­lion har­vest from their fran­chise drug in Q2 — com­pared to on­ly $111 mil­lion in rel­a­tive­ly ane­mic rev­enue for No­var­tis’ drug.

Eli Lil­ly’s ri­val in the CDK 4/6 field, Verzenio, al­so has yet to make much of an im­pact, but they still came out ahead of No­var­tis with $133 mil­lion in Q2 rev­enue for the drug.

Just 2 days ago Lil­ly her­ald­ed its own suc­cess on the OS front with their drug, al­so hold­ing back the da­ta for a fu­ture sci­en­tif­ic con­fer­ence. And their MONARCH-2 study in­clud­ed pre/peri- and post­menopausal women.

Here was the bot­tom line for No­var­tis at AS­CO: Kisqali com­bined with en­docrine ther­a­py spurred a 70.2% sur­vival rate among pre-menopausal women with hor­mone re­cep­tor-pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive (HR+/HER2-) ad­vanced or metasta­t­ic breast can­cer 42 months af­ter treat­ment be­gan. That’s sig­nif­i­cant­ly bet­ter — with a 27% drop in the risk of death — than the for­mer stan­dard of care, where 46% of pa­tients in the Monaleesa-7 con­trol arm were still alive.

No­var­tis has a pow­er­ful mar­ket­ing ma­chine, and you can ex­pect their team will do every­thing they can to go af­ter Ibrance. But Pfiz­er once again proves that be­ing the first to the mar­ket is a pow­er­ful ad­van­tage.

So­cial im­age: No­var­tis, AP Im­ages

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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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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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.

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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