Top 20 block­buster drugs in the late-stage pipeline — Eval­u­atePhar­ma

Every time news hits about an­oth­er biosim­i­lar to Hu­mi­ra, an­a­lysts are re­mind­ed that Ab­b­Vie $AB­BV is liv­ing on bor­rowed time. Ever since the big split with Ab­bott, the com­pa­ny has been wheel­ing and deal­ing its way in­to Phase III in a huge gam­ble that it can hold off copy­cats long enough to field a slate of drugs ca­pa­ble of re­plac­ing a ther­a­py that now de­liv­ers $16 bil­lion a year.

The new list from Eval­u­atePhar­ma on the top 20 late-stage drugs in the pipeline — in­clud­ed in its big an­nu­al re­port on the in­dus­try — un­der­scores just how hard that is, and al­so how much progress Ab­b­Vie is mak­ing.

Ab­b­Vie has 4 drugs in late-stage de­vel­op­ment that fall in the top 20, more than any oth­er com­pa­ny on the list. These drugs range from Ro­va-T (with a 2022 sales es­ti­mate of $1.5 bil­lion), fol­lowed by elagolix ($1.5 bil­lion), its promis­ing JAK1 in­hibitor ABT-494 ($1.2 bil­lion) and gle­capre­vir/pi­brentasvir ($1.2 bil­lion), which has been wide­ly ig­nored re­cent­ly as it made its way through late-stage hep C tri­als just as the mar­ket has be­gun to shrink fast.

Risky? The $5.4 bil­lion of col­lec­tive­ly pro­ject­ed an­nu­al rev­enue in­cludes a can­cer drug that many be­lieve Ab­b­Vie over­spent on in buy­ing Stem­cen­trx. And even if they all suc­ceed, it’s on­ly a por­tion of what Hu­mi­ra is good for, as long as they can hold on to patent pro­tec­tion.

If Eval­u­ate is right, Gilead $GILD could eas­i­ly ri­val Ab­b­Vie’s pack­age just with its lat­est cock­tail for HIV, adding bicte­gravir to the mix with po­ten­tial an­nu­al sales of $4.4 bil­lion — the high­est mon­ey­mak­er on the list and the on­ly one field­ed by Gilead, which has been hav­ing some trou­ble in the clin­ic over the past year.

No­vo Nordisk al­so helps demon­strate why one big drug in a big dis­ease field can be worth more than a host of small­er ther­a­pies. Its GLP-1 en­try semaglu­tide comes with $2.2 bil­lion in peak sales fore­cast.

J&J $JNJ comes in num­ber two in terms of to­tal num­ber of po­ten­tial block­busters, with three prod­ucts on the list: apa­lu­tamide ($1.6 bil­lion; re­mem­ber ARN-509 from Aragon?) fol­lowed by guselkum­ab ($1.5 bil­lion) and sirukum­ab ($1.1 bil­lion).

Two of the big biotechs, Bio­gen $BI­IB and Cel­gene $CELG, are rep­re­sent­ed here by ad­u­canum­ab — an­oth­er high-risk, high-re­ward play aimed at Alzheimer’s pegged at $1.5 bil­lion — and ozan­i­mod, sucked up in­to Cel­gene’s pipeline dur­ing one of the longest deal sprees in in­dus­try his­to­ry. Ozan­i­mod is as­signed 2022 po­ten­tial sales of $1.8 bil­lion.

In­cyte $IN­CY could ri­val ozan­i­mod sales though, with a sim­i­lar amount pro­vid­ed for epaca­do­stat, its lead­ing IDO1 drug which has fig­ured promi­nent­ly in the news re­cent­ly.

Not every­one is like­ly to agree that Kite’s lead CAR-T $KITE is worth twice the an­nu­al sales of No­var­tis’ leader $NVS in the field, as Eval­u­ate lists these fig­ures. But they’ll like­ly be giv­en plen­ty of op­por­tu­ni­ty to demon­strate their po­ten­tial fol­low­ing loom­ing PDU­FA dates on both.

As­traZeneca $AZN, which bad­ly needs to start gen­er­at­ing more rev­enue, is down to one on the list, now that dur­val­um­ab was ap­proved as the 5th PD-(L)1 check­point. But the CT­LA-4 cat­e­go­ry has been the cause of some fret­ting late­ly, and the drug falls just shy of block­buster sta­tus on the list.

Down­load the full re­port here: World Pre­view 2017, Out­look to 2022

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.