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

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.